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Sponsored by: |
Fondation Francaise de Cancerologie Digestive |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00303758 |
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, cisplatin, and gemcitabine, 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) and giving them in different ways may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating metastatic pancreatic cancer.
PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work in treating patients with metastatic pancreatic cancer that cannot be removed by surgery.
Condition | Intervention | Phase |
---|---|---|
Pancreatic Cancer |
Drug: cisplatin Drug: fluorouracil Drug: gemcitabine hydrochloride Drug: leucovorin calcium |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | Essai Randomise Comparant Deux Stategies De Chimiotherapie Dans Les Cancers Pancreatiques Avances: LV5FU2 Simplifie + Cisplatine Suivi de Gemcitabine, Versus Gemcitabine Suivi de LV5FU2 Simplifie + Cisplatine en Can de Progression |
Estimated Enrollment: | 202 |
Study Start Date: | October 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG performance status (0 or 1 vs 2), participating center, location of the tumor (ampullar region vs other locations), and infusion rate of gemcitabine hydrochloride (30 vs 100 minutes). Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive leucovorin calcium IV over 2 hours on day 1, cisplatin IV over 1 hour on day 1 or 2, and fluorouracil IV over 46 hours on day
1 and 2. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients with disease progression also receive gemcitabine hydrochloride IV over 30 or 100 minutes weekly for 7 weeks. Patients then receive gemcitabine hydrochloride IV on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and then every 2 months.
After completion of study therapy, patients are followed periodically for 2 years.
PROJECTED ACCRUAL: A total of 202 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the pancreas or ampulla
Measurable disease, meeting the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
France | |
C.H. Bourg En Bresse | |
Bourg En Bresse, France, 01012 | |
Centre de Lutte Contre le Cancer Georges-Francois Leclerc | |
Dijon, France, 21079 | |
Centre Eugene Marquis | |
Rennes, France, 35064 | |
Centre Hospital Universitaire Hop Huriez | |
Lille, France, 59037 | |
Centre Hospitalier d'Abbeville | |
Abbeville, France, 80101 | |
Centre Hospitalier de Blois | |
Blois, France, 41016 | |
Centre Hospitalier de Chalons-en-Champagne | |
Chalons-en-Champagne, France, 51000 | |
Centre Hospitalier De Dunkerque - CHD | |
Dunkerque, France, 59240 | |
Centre Hospitalier de Martigues | |
Martigues, France, 13698 | |
Centre Hospitalier de Saint-Quentin | |
Saint-Quentin, France, 02321 | |
Centre Hospitalier de Semur en Auxois | |
Semur en Auxois, France, 21140 | |
Centre Hospitalier de Soissons | |
Soissons cedex, France, 02209 | |
Centre Hospitalier de Tarbes | |
Tarbes, France, 65013 | |
Centre Hospitalier Docteur Duchenne | |
Boulogne Sur Mer, France, 62200 | |
Centre Hospitalier Draguignan | |
Draguignan, France, 83300 | |
Centre Hospitalier General de Mont de Marsan | |
Mont-de-Marsan, France, 40000 | |
Centre Hospitalier Intercommunal St. Aubin les Elbeuf | |
Elbeuf, France, 76503 | |
Centre Hospitalier Pierre Oudot | |
Bourgoin-Jallieu, France, 38300 | |
Centre Hospitalier Regional et Universitaire de Lille | |
Lille, France, 59037 | |
Centre Hospitalier Universitaire Ambroise Pare - Boulogne | |
Boulogne, France, F-92104 | |
Centre Hospitalier Universitaire d'Amiens | |
Caen, France, 14076 | |
Centre Joliot Curie Des Docteurs Jean-Christophe Chardon Jacques Hernandez Et Laurent Gasnault | |
Saint Martin Boulogne, France, 62280 | |
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | |
Montpellier, France, 34298 | |
Nouvelle Clinique Generale | |
Valence, France, 26000 | |
CHR D'Orleans - Hopital de la Source | |
Orleans, France, 45100 | |
CHR Hotel Dieu | |
Nantes, France, 44093 | |
CHU - Robert Debre | |
Reims, France, 51092 | |
CHU de Grenoble - Hopital de la Tronche | |
Grenoble, France, 38043 | |
CHU de la Timone | |
Marseille, France, 13385 | |
CHU Nord | |
Marseille, France, 13915 | |
Clinique Armoricaine De Radiologie | |
Saint Brieuc, France, F-22015 | |
Clinique Pasteur | |
Guilherand Granges, France, 07500 | |
Clinique Ste - Marie | |
Pontoise, France, 95301 | |
Hopital Beaujon | |
Clichy, France, 92118 | |
Hopital Bichat - Claude Bernard | |
Paris, France, 75018 | |
Hopital Charles Nicolle | |
Rouen, France, 76031 | |
Hopital Du Bocage | |
Dijon, France, 21034 | |
Hopital Duffaut | |
Avignon, France, 84902 | |
Hopital Edouard Herriot | |
Lyon, France, 69437 | |
Hopital Europeen Georges Pompidou | |
Paris, France, 75015 | |
Hopital Haut Leveque | |
Pessac, France, 33604 | |
Hopital Louis Pasteur | |
Colmar, France, 68024 | |
Hopital Robert Boulin | |
Libourne, France, 33500 | |
Hopital Saint Joseph | |
Marseille, France, 13008 | |
Hopital Universitaire Hautepierre | |
Strasbourg, France, 67098 | |
CHR Clermont Ferrand, Hotel dieu | |
Clermont-Ferrand, France, 63003 |
Study Chair: | Jean-Francois Seitz, MD | CHU de la Timone |
Investigator: | Jean-Louis Legoux, MD | Hopital Haut Leveque |
Investigator: | P. Hammel, MD, PhD | Hopital Beaujon |
Study ID Numbers: | CDR0000453841, FFCD-0301, EU-20543 |
Study First Received: | March 15, 2006 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00303758 History of Changes |
Health Authority: | United States: Federal Government |
adenocarcinoma of the pancreas recurrent pancreatic cancer stage IV pancreatic cancer |
Antimetabolites Immunologic Factors Pancreatic Neoplasms Disease Progression Leucovorin Pancrelipase Cisplatin Vitamins Micronutrients Gemcitabine Endocrine Gland Neoplasms Digestive System Neoplasms Vitamin B Complex |
Endocrine System Diseases Trace Elements Immunosuppressive Agents Antiviral Agents Recurrence Calcium, Dietary Digestive System Diseases Radiation-Sensitizing Agents Fluorouracil Pancreatic Diseases Gastrointestinal Neoplasms Endocrinopathy Adenocarcinoma |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Pancreatic Neoplasms Physiological Effects of Drugs Leucovorin Neoplasms by Site Therapeutic Uses Vitamins Micronutrients Gemcitabine |
Endocrine Gland Neoplasms Digestive System Neoplasms Vitamin B Complex Growth Substances Endocrine System Diseases Enzyme Inhibitors Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Digestive System Diseases Radiation-Sensitizing Agents Fluorouracil Pancreatic Diseases |