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	Treatment or Intervention	Phase
recurrent colon cancer adenocarcinoma of the rectum Stage IV rectal cancer recurrent rectal cancer stage IV colon cancer adenocarcinoma of the colon	Drug: fluorouracil  Drug: irinotecan  Drug: leucovorin calcium  Drug: oxaliplatin	Phase II

Further Study Details: 

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.

PROTOCOL 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   -   80 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--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

--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

--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

France
      American Hospital of Paris, Neuilly-sur-Seine,  F-92202,  France
      C.H. Senlis, Senlis,  60300,  France
      Centre Hospital Universitaire Hop Huriez, Lille,  59000,  France
      Centre Hospitalier de Mulhouse, Mulhouse,  68051,  France
      Centre Jean Bernard, Le Mans,  72000,  France
      CH Meulan, Meulan,  78250,  France
      CHU Pitie-Salpetriere, Paris,  75651,  France
      Clinique de l'Orangerie, Strasbourg,  67010,  France
      Clinique Saint Jean, Lyon,  69008,  France
      Hopital Bichat-Claude Bernard, Paris,  75018,  France
      Hopital Claude Gallien, Quincy-sous-Senart,  91480,  France
      Hopital Drevon, Dijon,  21000,  France
      Hopital Saint Antoine, Paris,  75571,  France
      Hopital Tenon, Paris,  75970,  France
      Intercommunal Hospital, Montfermeil,  93370,  France
      Polyclinique De Courlancy, Reims,  F-51100,  France

Study chairs or principal investigators

M. Hebbar,  Study Chair,  GERCOR   

Study ID Numbers:  CDR0000068128; FRE-GERCOR-C98-3-FIREFOX; EU-20023
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  August 3, 2000
ClinicalTrials.gov Identifier:  NCT00006115
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08