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Sponsored by: |
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006115 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic colorectal cancer that has not responded to previous chemotherapy.
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 |
Official Title: | Alternation of FOLFOX6 (Oxaliplatin - Leucovorin - Fluorouracil) and FOLFIRI (Irinotecan - Leucovorin - Fluorouracil) as Second Line Treatment of Metastatic Colorectal Cancer |
Study Start Date: | April 1999 |
OBJECTIVES: I. Determine the efficacy of oxaliplatin, leucovorin calcium, and fluorouracil followed by irinotecan, leucovorin calcium, and fluorouracil in terms of progression free survival in patients with metastatic colorectal cancer. II. Evaluate these treatment regimens in terms of overall survival, response rate, toxicity, and quality of life in this patient population.
OUTLINE: This is a multicenter study. Patients receive 4 courses of oxaliplatin IV and leucovorin calcium IV over 2 hours on day 1 followed by fluorouracil IV continuously over 46 hours. Following the initial 4 courses of therapy, patients receive 4 courses of irinotecan IV over 30-90 minutes and leucovorin calcium IV over 2 hours on day 1 followed by fluorouracil IV continuously over 46 hours. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed every 8 weeks. Patients are followed every 3 months until death.
PROJECTED ACCRUAL: A total of 14-39 patients will be accrued for this study over 12 months.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed metastatic adenocarcinoma of the colon or rectum Measurable or evaluable lesion or residual disease (e.g., ascites, bone metastases) Failure after first line therapy Fluorouracil and leucovorin calcium OR Raltitrexed No oxaliplatin or irinotecan Relapse within 6 months of adjuvant therapy Relapse within 6 months of hepatic artery infusion chemotherapy for resected hepatic metastasis No symptomatic brain metastasis
PATIENT CHARACTERISTICS: Age: 18 to 80 Performance status: WHO 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Hepatic: AST and ALT no greater than 3 times upper limit of normal (ULN) Alkaline phosphatase no greater than 5 times ULN Renal: Not specified Other: No bowel obstruction No other significant, uncontrolled underlying medical or psychiatric condition No serious active infection Neurologically stable No other prior malignancy except nonmelanomatous skin cancer or carcinoma in situ of the cervix No psychological, social, familial, or geographical condition that would preclude study Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: At least 2 weeks since prior radiotherapy Surgery: At least 2 weeks since prior surgery Other: No other concurrent experimental drugs
France | |
American Hospital of Paris | |
Neuilly Sur Seine, France, F-92202 | |
C.H. Senlis | |
Senlis, France, 60300 | |
Centre Hospital Universitaire Hop Huriez | |
Lille, France, 59000 | |
Centre Hospitalier de Mulhouse | |
Mulhouse, France, 68051 | |
Centre Jean Bernard | |
Le Mans, France, 72000 | |
CH Meulan | |
Meulan, France, 78250 | |
CHU Pitie-Salpetriere | |
Paris, France, 75651 | |
Clinique de l'Orangerie | |
Strasbourg, France, 67010 | |
Polyclinique De Courlancy | |
Reims, France, F-51100 | |
Hopital Bichat-Claude Bernard | |
Paris, France, 75018 | |
Hopital Claude Gallien | |
Quincy Sous Senart, France, 91480 | |
Hopital Drevon | |
Dijon, France, 21000 | |
Hopital Saint Antoine | |
Paris, France, 75571 | |
Hopital Tenon | |
Paris, France, 75970 | |
Intercommunal Hospital | |
Montfermeil, France, 93370 | |
Clinique Saint Jean | |
Lyon, France, 69008 |
Study Chair: | Mohamed Hebbar, MD | Centre Hospital Universitaire Hop Huriez |
Study ID Numbers: | CDR0000068128, FRE-GERCOR-C98-3-FIREFOX, EU-20023 |
Study First Received: | August 3, 2000 |
Last Updated: | January 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00006115 |
Health Authority: | United States: Federal Government |
stage IV colon cancer stage IV rectal cancer recurrent colon cancer |
recurrent rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum |
Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Irinotecan Colonic Diseases Leucovorin Intestinal Diseases Rectal Diseases Camptothecin Recurrence |
Intestinal Neoplasms Rectal neoplasm Calcium, Dietary Oxaliplatin Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Adenocarcinoma Rectal cancer Colorectal Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Vitamin B Complex Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Vitamins Micronutrients Antineoplastic Agents, Phytogenic |