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Trials of Treatment for Pancreatic, Neuroendocrine, Ampullary and Bile Duct Cancer
This page attempts to bring together sources of information on trials of treatment for mainly pancreatic adenocarcinoma but also includes some information on neuroendocrine, ampullary and bile duct cancer in the UK.
There are a number of sources of information on clinical trials for pancreatic cancer. These pages attempt to list the sources of information and provides information on the trials that we are aware of but some may have closed or new trials may have started since the pages were last updated. An update to the pages does not imply that all the information has been checked. It just means that some new trials may have been added or old ones removed or the content redesigned. There are a number of trial databases which may or may not be updated more frequently than the information on the rest of this page so it is worth checking the databases directly as they may contain information on trials not listed below. It will also be worth checking directly with hospitals specializing in pancreatic cancer.
Many trials never appear in the databases. There are many different trials available throughout the country and patients should discuss with their own oncologist what would be the most suitable treatment for them.
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ESPAC-4 - National Adjuvant treatment with combination chemotherapy gemcitabine plus capecitabine versus single agent chemotherapy of gemcitabine is open in Liverpool and Clatterbridge and due to open nationally soon. information from Liverpool cancer Trials Unit. Pancreatic cancer can sometimes be treated with surgery. If the growth in your pancreas has been removed with surgery, there is a chance that your cancer could come back. There is a possibility that giving chemotherapy after surgery, may prevent this happening. This is called adjuvant therapy. Nobody is sure which are the best chemotherapy drugs to use. This trial is to find out whether giving gemcitabine or giving gemcitabine with the addition of the tablets capecitabine is more effective after surgery. Extra info from CancerHelp UK web-site
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Telovac - Dr Gary Middleton, Royal Surrey County Hospital, Guildford
This national Phase III trial compares combination gemcitabine and capecitabine chemotherapy with concurrent and sequential chemoimmunotherapy using a telomerase vaccine in locally advanced and metastatic pancreatic cancer. The trial is being extended to include patients whose cancer has returned following surgery as long as it is more than 12 months since last chemotherapy/treatment. Information on trial. Telomerase vaccine therapy has shown benefit in pancreatic cancer and is being trialled in combination with GemCap chemotherapy. The telomerase vaccine, GV1001, has been developed by Danish-based biotech company Pharmexa.
The trial is open at 44 sites throughout the UK and more sites are due to open soon. 65 centres have expressed interest in joining. More information from Liverpool Cancer Trials Unit and CancerHelp UK.See the uptodate list of open sites on the Liverpool Cancer Trials Unit web-site. Further information on our web-page on this trial.
TARGET - Royal Marsden Hospital A Phase I-II Dose Finding and Early Efficacy Study of Combination Therapy With Erlotinib (Tarceva), Gemcitabine, Bevacizumab (Avastin), and Capecitabine in Advanced Pancreatic Cancer.Pancreatic cancer is an aggressive, largely chemo-resistant disease with a poor prognosis. EGFR and VEGF are both overexpressed in pancreatic cancers and thought to contribute to tumour development and progression. The combination of gemcitabine and capecitabine has recently been shown to be effective in advanced pancreatic cancer. The combination of gemcitabine plus erlotinib has also been shown to be effective in advanced pancreatic cancer. The aim of this study is to assess whether combining a chemotherapy doublet (gemcitabine plus capecitabine) and a biologic doublet (erlotinib plus bevacizumab) is a safe and effective way to treat advanced pancreatic cancer by targeting multiple tumour stimulating mechanisms simultaneously. Planned to extend to Clatterbridge, Mount Vernon and Maidstone.
PACER - Locally Advanced Pancreatic Cancer: Phase II Study of Cetuximab and 3-D Conformal Image Guided Radiotherapy
Cetuximab and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed by Surgery. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving cetuximab together with 3-dimensional conformal radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cetuximab together with radiation therapy works in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.
info on trial open at Christie Hospital Manchester and Cookridge Hospital Leeds. Extra info from CancerHelp UK web-site
AG-013736 In Combination With Gemcitabine Versus Gemcitabine Alone For Patients With Metastatic Pancreatic Cancer This is a Phase 2 study being conducted at multiple centers in the United States, Europe and Canada. Patients having pancreatic cancer that has spread to other parts of the body (i.e., metastatic) are eligible to participate. Patients must have not had any prior treatment for metastatic disease. The purpose of the study is to test whether the angiogenesis inhibitor AG-013736 in combination with gemcitabine is an effective treatment for metastatic and locally advanced pancreatic cancer vs. gemcitabine alone by overall survival. In the UK this study is running at
London, Southampton, Edinburgh and Leicester. More information from CancerTrials.gov web-site. At Leicester it is only open to locally advanced patients. No longer recruiting patients.
PARC - Randomized phase II study evaluating EGFR targeting therapy with Cetuximab in combination with radiotherapy and chemotherapy for patients with locally advanced pancreatic cancer info on trial open at St Barts and the London.
KU36-29 - is a phase 1 of Gemcitabine with AZD2281, a PARP inhibitor info on trial open at Oxford and Royal Marsden. Study to Assess the Safety & Tolerability of a PARP Inhibitor in Combination With Gemcitabine in Pancreatic Cancer
SCALOP - Randomized phase II study to evaluate activity, safety and feasibility of two chemoradiotherapy treatments for locally advanced cancer. It compares chemoradiotherapy with gemcitabine or capecitabine following gemcitabine plus capecitabine chemotherapy. Extra information from CancerHelpUK site. Open at Velindre, Cardiff and will open at other centres soon.
It is always worth inquiring at your local centre about whether they are running trials as many never appear in the databases, especially those sponsored by drug companies and phase I/II trials.
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A Phase I Study of Gemcitabine Plus Oxaliplatin in Combination with imatinib mesylate (Glivec) in Patients with Gemcitabine-Refractory Advanced Adenocarcinoma of the Pancreas . Royal Marsden Hospital. To work out the optimal doses of the novel combination of gemcitabine, oxaliplatin and imatinib mesylate (glivec) in patients with advanced pancreatic cancer that has progressed during or after treatment with first-line gemcitabine. Using a Phase I study design, the dose of gemcitabine will be escalated in several steps to identify the highest tolerable dose that can be given safely. Based on pre-defined dose-limiting toxicity, the maximum tolerated dose of the combination will be identified and a safe dose for further evaluation of this regimen in pancreatic cancer selected. National Research register N0258175366
more information
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Metxia: gene therapy : two-stage Phase I/II clinical trial in patients with pancreatic cancer at Division of Surgery and Oncology, University of Liverpool (Royal Liverpool University Hospital) and Hammersmith Hospital, London
In this trial patients will have MetXia-OB83 (MetXia) and the chemotherapy drug cyclophosphamide. MetXia is a new treatment that is not licensed yet. It is a type of gene therapy. The genetic material (DNA) within each cell controls the cell by telling it which proteins to make. In this trial, a virus carries a new piece of DNA into the cancer cells. The researchers have treated the virus so it will not cause an infection. The new DNA tells the cell to make an enzyme called cytochrome P-450 (usually made in liver cells). This enzyme makes cyclophosphamide more active. In theory, when the cyclophosphamide comes into contact with the cytochrome P-450 inside the pancreatic cancer cell, it will kill the cell.
Extra info from Cancer HelpUK site. Part I to select gene level has been successfully completed and Part II to select doseage of chemotherapy is now complete.
Mcm 5 protein test to diagnose cancer of the bile duct, gall bladder or pancreas.
Cancer of the bile duct, gall bladder or pancreas is usually diagnosed using blood tests, scans and a biopsy. But it is not always easy to be sure of the diagnosis based on these results.
Doctors hope a test that looks for a protein called Mcm5 will be better at diagnosing these cancers. Mcm stands for 'minichromosome maintenance' protein. This is a new test, and doctors are not sure yet how good it will be. We need to make sure it is accurate and reliable before it can be widely used to diagnose cancer.
In this trial, patients will have the Mcm5 test as well as the usual tests, not instead of them. If you take part, the results of the Mcm5 test will not affect your treatment or care. But if the trial proves the Mcm5 test is good enough, it may benefit other patients in the future.
The aim of this trial is to find out if testing for the Mcm5 protein can help diagnose cancer of the bile duct, gall bladder or pancreas. Extra info from Cancer HelpUK site
32P BioSiliconTM in Addition to Gemcitabine in Pancreatic Cancer
ClinicalTrials.Gov says: "The first study investigated the safety of 32P BioSilicon in patients with advanced,unresectable pancreatic cancer who are also receiving standard intravenous gemcitabine chemotherapy. The secondary aims of the study assessed the implantation procedure, localisation of 32P BioSilicon, tumour response and survival parameters. A second small study is noe open escalating the dose of radiotherapy delivered via the biospheres
"Tumours targetted with 32P BioSilicon is hypothesized to show a reduction in tumour volume and with the low radioactivity dose that is delivered intratumourally, the incidence of side effects associated with the treatment is expected to be low. Prologation of survival and improved quality of life could be favourable outcomes of the investigational product. " Open at Guy's and St Thomas' Hospital NHS Trust, London, SE1 9RT, United Kingdom and is/will be open to recruitment in Birmingham. ; Recruiting Paul Ross, MBBS,PhD 020 7188 4249. see ClinicalTrials.Gov for more details
ACVA for cancers that that test positive for carcinoembryonic antigen (CEA) (PH1/099) - Phase 1 trial
ACVA is a new and experimental treatment. It is a type of biological therapy known as a DNA vaccine. It is made from the tetanus vaccine, but researchers have added some new genetic material (DNA) to modify it. Because the genetic material has been changed, it is also classed as a type of gene therapy.
Some cancer cells have a protein called carcinoembryonic antigen (CEA) on the surface of the cell (they 'express' CEA). The research team hope that ACVA will help the immune system to recognise cells with CEA on them and kill them. But they are not sure yet how well this will work.
This trial will recruit some patients with advanced cancer that has spread to another part of the body (metastasised). And some who have no signs of cancer following treatment (are 'in remission'). All patients taking part will have cancers that express CEA.
The aims of the trial are to find out if ACVA can stimulate the immune system to recognise and kill cancer cells that express CEA, what the side effects are and what happens to the level of CEA in the body. Open at Southampton. Extra information from CancerHelpUK site
VERTPAC - phase I trial of verteporfin photodynamic therapy in locally advanced unresectable pancreatic carcinomaThis trial is looking at photodynamic therapy using a drug called verteporfin for pancreatic cancer that cannot be removed with surgery.
Cancer of the pancreas is very difficult to treat. Even if it has not spread anywhere else in the body, surgery to remove pancreatic cancer may not be possible. Researchers are looking for new ways of treating pancreatic cancer that cannot be removed with surgery.
In this trial, they are looking at photodynamic therapy (PDT). This is a very experimental treatment using a drug called verteporfin. Verteporfin makes cancer cells sensitive to light (a photosensitiser). In trials of PDT for other types of cancer, different photosensitisers have been used, but the researchers think that verteporfin may have fewer side effects.
You have verteporfin as an injection into a vein. After the drug has had time to get into the cancer cells, the doctor aims a laser light at them. They hope that this will kill some of the cancer cells.
The aims of this trial are to see if photodynamic therapy using verteporfin is safe, find out if it helps people with pancreatic cancer, learn more about the side effects. Open at University College London Hospital. Extra information from CancerHelpUK site
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EPA nutritional supplement to treat Cancer Cachexia
A pragmatic parallel-randomised single blind controlled trial to investigate the efficacy of an oral nutritional supplementation Prosure™ containing the omega-3 fatty acid, eicosapentaenoic acid or EPA to prevent or delay the development of cachexia in patients with specific incurable solid tumour cancer
- extra info from NCRN
Enteral Nutrition Trial University Hospital of Wales, Cardiff,
A randomised controlled trial of early enteral nutrition after major gastrointestinal resection for malignancy
Thalidomide in cancer cachexia The use of thalidomide as a treatment for cancer cachexia. contact: Dr Susi Green, Queen Alexandra Hospital Portsmouth, Southwick Hill Road, Cosham, Portsmouth, PO6 3LY
- extra info from NCRN
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Infliximab (C0168T60) - Dr Pippa Corrie, Addenbrooks, Cambridge
A phase II, multi-centre, randomised , double-blind, placbo-contolled study evaluating the efficacy and safety of anti-TNF Monoclonal antibody (infliximab) to treat cancer-related cachexia in subjects with pancreatic cancer. 3 arm study of gemcitabine with placebo or Infliximab -
info (pdf)
Gene therapy - St Barts and the Royal London A new gene therapy suite is due to open at St Barts, London soon. The first trials are likely to be for intraperitoneal disease, and for liver metastases respectively
A Biomarker Identification Trial of Tarceva (Erlotinib) in Patients With Advanced Pancreatic Cancer This study is designed to identify biomarkers which may predict improvement in progression free survival from treatment with Tarceva, in patients with advanced pancreatic cancer who failed one prior regimen of standard chemotherapy or who are deemed unsuitable for chemotherapy. It will also assess the efficacy and safety of Tarceva in this patient population. Patients will be randomized to receive either Tarceva 150mg/day po, or placebo po daily. Tumor tissue will be used for biomarker analysis. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals. more details London
A Dose-Escalation to Rash Study of Tarceva (Erlotinib) Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer London and Southampton more info
Phase II Study of Brivanib (BMS-582664) to Treat Multiple Tumor Types
A Randomized Discontinuation Study of Brivanib Alaninate (BMS-582664) Versus Placebo in Subjects With Advanced Tumors. The purpose of this study is to determine if gastric/esophageal, lung, pancreatic, bladder and sarcoma patients show benefit from brivanib treatment. Patients who clearly do, stay on treatment. Those in which it is unclear will be randomized to continue or withdraw treatment to determine whether that benefit is related to brivanib. Patients eligable are those for whom diagnosis of a solid tumor which is unresectable in which no approved effective therapy exists or for subjects who are intolerable to such therapy. more info Surrey
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NET-01 - Dr Pippa Corrie, Addenbrooks, Cambridge and UKNETwork
A Randomised Phase II Study Comparing Capecitabine Plus Streptozocin ('Cap-Strep') With Capecitabine Plus Streptozocin Plus Cisplatin ('Cap-Cist') In The Treatment Of Unresectable Or Metastatic Neuroendocrine Tumours RATIONALE: Drugs used in chemotherapy, such as capecitabine, streptozocin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving capecitabine together with streptozocin is more effective with or without cisplatin in treating neuroendocrine tumors. PURPOSE: This randomized phase II trial is studying giving capecitabine together with streptozocin to see how well it works compared with or without cisplatin in treating patients with unresectable or metastatic neuroendocrine tumors. - info (pdf).
Birmingham, Cambridge, Cardiff, Edinburgh, Glasgow, Leeds, Leicester, Royal Free Hospital London, Christie Hospital Manchester, Newcastle, Maidstone, Royal Marsden Surrey, St Thomas' London more info
Study of Lanreotide Autogel in Non-Functioning Entero-Pancreatic Endocrine Tumours
Phase III, Randomised, Double-Blind, Stratified Comparative, Placebo Controlled, Parallel Group, Multi-Centre Study to Assess the Effect of Deep Subcutaneous Injections of Lanreotide Autogel 120mg Administered Every 28 Days on Tumour Progression Free Survival in Patients With Non-Functioning Entero-Pancreatic Endocrine Tumour
- info.QMC Nottingham,
University Hospital Cardiff, Western General Edinburgh, Western Infirmary Glasgow, Cookridge Leeds, Leicester, Royal Free Hospital London, Sheffield, St Barts, Newcastle, Belfast, Oxford
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ABC02
Gemcitabine alone or in combination with cisplatin, in patients with advanced or metastatic cholangiocarcinomas and other biliary tract tumours: a multicentre, randomised phase III study (60 months) - awarded CRUK CTAAC Feb 2004. RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether gemcitabine is more effective with or without cisplatin in treating cholangiocarcinoma or biliary tract tumors.PURPOSE: This randomized phase III trial is studying gemcitabine and cisplatin to see how well they work compared to gemcitabine alone in treating patients with unresectable locally advanced or metastatic cholangiocarcinoma or other biliary tract tumors.
- extra info from NCRN and
More information from CancerTrials.gov web-site. Open at 40 centres around UK
BILCAP
A randomised clinical trial evaluating adjuvant chemotherapy with capecitabine compared to expectant treatment alone following surgery for biliary tract cancer. RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving capecitabine after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether capecitabine is more effective than observation in treating biliary tract cancer. PURPOSE: This randomized phase III trial is studying capecitabine to see how well it works compared with observation in treating patients with biliary tract cancer. - extra info from NCRN
and info including open centres. Open at 35 centres around UK.
PHOPKREP 03-01
A phase IV trial to see how the body gets rid of photodynamic therapy drugs. more info from CancerHelpUK site
PHOTOSTENT-02
Porfimer Sodium Photodynamic Therapy Plus Stenting Versus Stenting Alone in Patients With Advanced or Metastatic Cholangiocarcinomas and Other Biliary Tract Tumours: a Multicentre, Randomised, Phase Lll Study. RATIONALE: Biliary stenting is the placement of a tube in the bile ducts to keep a blocked area open. Photodynamic therapy uses a drug, such as porfimer sodium, that is absorbed by tumor cells. The drug becomes active when it is exposed to light. When the drug is active, tumor cells are killed. It is not yet known whether biliary stenting is more effective with or without photodynamic therapy in treating patients with biliary tract tumors.PURPOSE: This randomized phase III trial is studying biliary stenting to see how well it works compared with biliary stenting and photodynamic therapy using porfimer sodium in treating patients with locally advanced, recurrent, or metastatic cholangiocarcinoma or other biliary tract tumors that cannot be removed by surgery. info on trial open for recruitment in Aintree(Liverpool), UCLH(London), QMC(Nottingham), Ninewells(Dundee)
RMH E/C 1323
A Randomised trial comparing epirubicin, cisplatin and PVI 5FU (ECF) to 5FU, Etoposide Leucovorin (FELU) in patients with inoperable or metastatic biliary cancer. - extra info from UKCCCR
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PAPRIKA Phase 3 Randomised, open label trial for 2nd line therapy in advanced pancreatic cancer– Chief Investigator Professor William Steward, Leicester Royal Infirmary. This trial was for patients with advanced (inoperable), locally recurrent or metastatic disease who have previously been treated with a gemcitabine containing chemotherapy regimen . The purpose of this clinical study is to determine if a new taxane called larotaxel (XRP9881) is a better treatment than 5FU or capecitabine for patients with pancreatic cancer which has failed to respond to first-line gemcitabine or has recurred after previous treatment with gemcitabine. The trial was open at Leicester Royal Infirmary, Bristol Haematology and Oncology Centre, Mount Vernon Hospital, Guy's & St Thomas' Hospital, Christie Hospital Manchester, Clatterbridge Centre for Oncology, Plymouth Oncology Centre.
information
A Phase III Randomized, Double-Blind Study Of Sunitinib (SU011248, Sutent) Versus Placebo In Patients With Progressive Advanced/Metastatic Well-Differentiated Pancreatic Islet Cell Tumors
This study randomized patients with advanced pancreatic islet cell tumors to receive either sunitinib or placebo. Patients who were randomized to sunitinib received 37.5 mg of sunitinib daily, those randomized to placebo received a tablet that looked similar but had no active drug. Neither the patient or the doctor knew whether the patient was receiving sunitinib or placebo. Patients were followed to determine the status and size of their tumors, survival, quality of life and safety of the drug. - info. Liverpool, Leeds and Manchester were recruiting.
FRAGEM - Humber and Yorkshire Coast Cancer Research Network. Phase II randomised study of chemo-anticoagulation (Gemcitabine_LMWH) vs chemotherapy alone (Gemcitabine) for locally advanced and metastatic pancreatic adenocarcinoma. Some cancers release certain chemicals that help the blood to clot, or coagulate. This is called 'activating the coagulation system'. It increases the risk of a blood clot developing in a blood vessel. The number of people with pancreatic cancer that develop a blood clot is 1 in 4 (25%). This is a higher rate than for any other cancer. This trial compares gemcitabine and dalteparin or gemcitabine alone for advanced pancreatic cancer. The aim of the trial is to see how many patients in each group develop blood clots, and to see if dalteparin can effect how well patients do. Centres running the trial included: Hull, Maidstone and Kent, Royal Lancaster, Barts & The London, Guys Kings and St Thomas’ , Nottingham City, St Georges' London, Scarborough, Scunthorpe, Grimsby.
Phase III Randomized Study Of Gemcitabine Plus AG-013736 (Axitinib) Versus Gemcitabine For first line treatment in Advanced Pancreatic Cancer. Randomized, Double-Blind Phase 3 Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine Plus Placebo For The First-Line Treatment Of Patients With Locally Advanced, Unresectable Or Metastatic Pancreatic Cancer. AG-013736 is a vascular endothelial growth factor inhibito. Open at many sites in London (including Hammersmith), Christie Manchester, Leicester, Mount Vernon, Birmingham trial info. Open soon in Edinburgh, Cardiff, Maidstone, Southampton
GEMCAP , - required number of participants (accrual) achieved ahead of schedule and preliminary results announced on 2nd November 2005. Single or combination chemotherapy for patients who have advanced cancer of the pancreas (GEM-CAP)- Phase III multicentre randomised clinical trial comparing gemcitabine alone or in combination with capecitabine for the treatment of patients with advanced pancreatic cancer. Unfortunately, most patients with pancreatic cancer cannot have surgery because their cancer is too advanced when it is diagnosed. Doctors believe that giving chemotherapy will help patients by improving symptoms. The study investigated whether adding the chemotherapy tablets capecitabine (xeloda) to the standard treatment of gemcitabine injections is better than gemcitabine alone.
ESPAC -3 V2(European Study Group for Pancreatic Cancer Trial 3: Adjuvant Chemotherapies in Operable Pancreatic and Ampullary Cancer ),
info from Cancer HelpUK site and
Liverpool cancer Trials Unit
The trial completed 13th Dec 2006 for pancreatic cancer and in 2008 for ampullary cancer. more info
AviTa - metastatic disease - Phase III 2 arm study of gemcitabine plus tarceva(erlotinib) with either Avastin(bevacizumab) or placebo. Run at Leicester Royal Infirmary under PI Prof Will Steward and in some other centres in UK including Royal Marsden (London and Sutton), Christie's (Manchester), Mount Vernon, Royal Cornwall Hospital and Glasgow(Beatson). No prior treatment for advanced disease was permitted but patients can have received prior adjuvant chemotherapy.
More information is available on the Roche trials web-site.
FATPAC -1 (Fatty Acid Treatment in PAncreatic Cancer) - Dr John Bridgewater,
University London College Hospital
Randomised double blind phase III study comparing Resource Support® to a
standard nutritional supplement in patients with advanced pancreatic cancer.
The trial investigates the benefit of taking supplementary amounts of a
naturally occurring compound known as EPA (eicosapentaenoic acid) compared
to a standard nutritional supplement. This compound EPA is a key ingredient
of a formulation called Resource Support®. This will be in addition to any
standard chemotherapy treatment for your cancer of the pancreas. In some other studies, EPA, also known as an OMEGA 3 fatty acid, has been
shown to change the balance of chemicals produced by cancer. It is felt that
this change may improve the symptoms that you are having from your cancer,
in particular the weight loss, but this is not certain. In order to prove
any benefit of EPA, in this study, patients will be randomly allocated into
one of two groups, those receiving EPA together with a nutritional
supplement and of those having the nutritional supplement alone. This
supplement will provide an equally nourishing drink, but without the EPA.
contact: Dr John Bridgewater tel:02073809093 University London College
Hospital. Trial is open to patients receiving treatment at other hospitals with prior consent from their consultant.
NUT Study
A randomised controlled trial of nutritional intervention for patients with weight loss who are undergoing chemotherapy for gastrointestinal malignancy. - extra info from NCRN
Malignant Ascites - Trifunctional Antibody - Mr Simon Parsons, Nottingham
Multicentre trial for all forms of cancer, including pancreatic, open in Nottingham (phone Mr Parsons at Nottingham City Hospital 0115 969 1169), Liverpool (phone Ms A Sultana 0151 706 4199), Birmingham, Royal Marsden, Maidstone, Aberdeen. This trial compares effectiveness of draining ascites to treatment by the trifunctional antibody removab (anti-EpCAM x anti-CD3). It is a 2-arm, randomized, open-label phase II/III pivotal study in EpCAM positive cancer patients with symptomatic malignant ascites using paracentesis (ie draining of fluid) plus the tri-functional antibody removab versus paracentesis alone. It is hoped that the antibody will stimulate the immune system to destroy cancer cells. This trial was for patients with advanced/inoperable disease. The aim of the trial WAs to treat ascites and hopefully control symptoms effectively so that the patient doesn't need repeated drainage.
Trial now closed.
NTRAC - GLA GI58 - Beatson Oncology Centre Glasgow (Part of Glasgow-Dundee NTRAC Centre)
A Phase I Study Of Capecitabine Based Chemoradiation In Patients With Localised Non-Operable Carcinoma Of The Exocrine Pancreas.Patients diagnosed with inoperable pancreatic cancer are often offered a treatment combination of radiotherapy and chemotherapy. This treatment usually involves radiotherapy being given together with a drug called 5-fluorourcil (5-FU). 5-FU is normally given via an intravenous drip. Capecitabine is a tablet which converts in to 5-FU once inside the body. Capecitabine has proved to be a useful substitute for 5-FU for the treatment of several other types of cancer.
The aim of this trial is to see if the use of radiotherapy and capecitabine is as effective as using 5-FU for the treatment of patients diagnosed with non-operable pancreatic cancer.
CetCisGem - Hammersmith Hospital under Dr Harpreet Wasan Phase II trial of
antibody called Erbitux or Cetuximab (a EGFR inhibitor) with very high
activity (about to be licensed for bowel cancer), in combination with
Gemcitabine and cisplatin in Pancreatic Cancer. This was due to be combined with molecular profiles.
NATTS - a study comparing methods of pain relief for patients with advanced abdominal cancer. It was a 3 arm randomized trial comparing painkillers, coeliac plexus block(injection into nerve of the back under CT or ultrasound guidance) and thoracoscopic splanchnicectomy(cutting splanchnic nerve through the chest)
SONG - Chemotherapy before surgery for pancreatic cancer - gemcitabine or gemcitabine and cisplatin
KABI (monoclonal antibody) , Division of Surgery and Oncology, University of Liverpool
A Phase I/II trial of Monoclonal antibody and iodine treatment. In this trial patients will have a new treatment called I 131 KAb201. KAb201 is a monoclonal antibody. It targets a protein called CEA, which is produced by some pancreatic cancers. Trial now closed.
Oncovex - gene therapy for pancreatic cancer that has spread to the skin, London Prof Coombes
Z-360 in Unresectable Advanced Pancreatic Cancer in Combination With Gemcitabine Treatment
To evaluate the safety of two doses of Z-360 with Gemcitabine administration for subjects with unresectable advanced pancreatic cancer in order to determine the optimal dosage for PhaseII study.
Study open in UK at Royal Free Hospital, London. Phase 1 study?
More information from CancerTrials.gov web-site.
ABR-217620 in Patients With Advanced Non-Small Cell Lung Cancer, Renal Clear Cell Carcinoma or Pancreatic Cancer
The drug ABR-217620 is a combination of two proteins, one that recognizes tumor cells and one that triggers an attack on the tumor cells by activating some white blood cells belonging to the body's normal immune system. In animals, this results in an accumulation of white blood cells in the cancer that can fight the cancer. This study will test how much of the drug can be given to patients with non-small cell lung cancer, renal clear cell carcinoma, or pancreatic cancer without causing unacceptable side effects. Study open in UK at Christie Hospital, Manchester. Phase 1 study?
More information from CancerTrials.gov web-site.
Phase II Study of Volociximab(M200) in Combination With Gemcitabine in Metastatic Pancreatic Cancer M200/placebo (an anti VEGF treatment) was open at centres such as Mount Vernon and Beatson Glasgow, Christie Manchester and Cookridge Leeds in the UK. Trial info
A phase II study of ABR-214936 (anatumomab mafenatox) tumour targeted superantigen (TTS) therapy in patients with advanced adenocarcinoma of the pancreas Christie Hospital Manchester abstract
Phase II study of Triapine (3-AP) with Gemcitabine in Patients with unresectable or metastatic Pancreatic Cancer . Was open at Christie Manchester and Royal Marsden Sutton. trial info
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ESPAC-3(v2) Phase III Adjuvant Trial in Pancreatic Cancer Comparing 5FU and D-L-Folinic Acid vs. Gemcitabine. Leeds, UK: National Cancer Research Network Trials Portfolio, 200
Phase III randomised comparison of gemcitabine (GEM) versus gemcitabine plus capecitabine (GEM-CAP) in patients with advanced pancreatic cancer ECCO abstract 2 Nov 2005, D. Cunningham, I. Chau, D. Stocken, C. Davies, J. Dunn, J. Valle, D. Smith, W. Steward, P. Harper, J. Neoptolemos
Neoptolemos JP, Stocken DD, Friess H, Bassi C, Dunn JA, Hickey H, Beger H, Fernandez-Cruz L, Dervenis C, Lacaine F, Falconi M, Pederzoli P, Pap A, Spooner D, Kerr DJ, Buchler MW; European Study Group for Pancreatic Cancer. A randomized trial of chemoradiotherapy and chemotherapy after resection of pancreatic cancer. N Engl J Med. 2004 Mar 18; 350(12):1200-10. Erratum in: N Engl J Med. 2004 Aug 12;351(7):726.
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