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Sponsored by: |
Federation Nationale des Centres de Lutte Contre le Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00066274 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying combination chemotherapy containing irinotecan and oxaliplatin to see how well it works compared to two standard combination chemotherapy regimens in treating patients with unresectable metastatic colorectal cancer.
Condition | Intervention | Phase |
---|---|---|
Colorectal Cancer |
Drug: FOLFIRI regimen Drug: FOLFOX regimen Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium Drug: oxaliplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Randomized Phase II Study Evaluating Three Chemotherapies: [Irinotecan + Oxaliplatin (Irinox)], [Irinotecan + LV5FU2] and [Oxaliplatin + LV5FU2] as First Intention Treatment in Subjects With Metastatic Colorectal Cancer |
Study Start Date: | May 2002 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms.
Quality of life is assessed at baseline and then every 3 months for 1 year.
Patients are followed at 2 months.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 1 year.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed colorectal carcinoma
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiac
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
France | |
Centre Antoine Lacassagne | |
Nice, France, 06189 | |
Centre Eugene Marquis | |
Rennes, France, 35062 | |
Centre Hospitalier de L' Agglomeration Montargoise | |
Amilly, France, 45207 | |
Centre Hospitalier de Rodez | |
Rodez, France, 12027 | |
Centre Hospitalier Departemental | |
La Roche Sur Yon, France, F-85025 | |
Centre Hospitalier General Lucien Hussel | |
Vienne, France, 38200 | |
Centre Hospitalier Regional Metz Thionville | |
Thionville, France, 57126 | |
Centre Oscar Lambret | |
Lille, France, 59020 | |
Polyclinique Francheville | |
Perigueux, France, 24004 | |
Centre Regional Francois Baclesse | |
Caen, France, 14076 | |
Centre Rene Huguenin | |
Saint Cloud, France, 92210 | |
CHG Roanne | |
Roanne, France, F-42300 | |
CHR D'Orleans - Hopital de la Source | |
Orleans, France, 45100 | |
Clinique Sainte-Marguerite | |
Hyeres, France, 83400 | |
Institut Bergonie | |
Bordeaux, France, 33076 | |
Pole Sante Sarthe et Loir Hopital Pierre Daguet | |
Angers, France, 49036 | |
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | |
Montpellier, France, 34298 |
Study Chair: | Yves Becouarn, MD | Institut Bergonie |
Study ID Numbers: | CDR0000315384, FRE-FNCLCC-ACCORD-08/0103, EU-20233 |
Study First Received: | August 6, 2003 |
Last Updated: | January 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00066274 History of Changes |
Health Authority: | United States: Federal Government |
stage IV colon cancer stage IV rectal cancer |
Antimetabolites Immunologic Factors Gastrointestinal Diseases Rectal Neoplasms Colonic Diseases Irinotecan Leucovorin Rectal Diseases Oxaliplatin Vitamins Micronutrients Digestive System Neoplasms Vitamin B Complex |
Rectal Neoplasm Trace Elements Intestinal Diseases Immunosuppressive Agents Intestinal Neoplasms Camptothecin Calcium, Dietary Rectal Cancer Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic Colorectal Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Gastrointestinal Diseases Antineoplastic Agents Colonic Diseases Irinotecan Physiological Effects of Drugs Leucovorin Rectal Diseases Oxaliplatin Neoplasms by Site Vitamins Therapeutic Uses |
Micronutrients Vitamin B Complex Digestive System Neoplasms Growth Substances Enzyme Inhibitors Intestinal Diseases Immunosuppressive Agents Intestinal Neoplasms Camptothecin Pharmacologic Actions Neoplasms Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic |