Alternation of FOLFOX6 (Oxaliplatin - Leucovorin - Fluorouracil) and FOLFIRI (Irinotecan - Leucovorin - Fluorouracil) as Second Line Treatment of Metastatic Colorectal Cancer
18 Years
80 Years
Both
Colorectal Cancer
Trial Information
Alternation of FOLFOX6 (Oxaliplatin - Leucovorin - Fluorouracil) and FOLFIRI (Irinotecan - Leucovorin - Fluorouracil) as Second Line Treatment of Metastatic Colorectal Cancer
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.
Inclusion 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
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Mohamed Hebbar, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Centre Hospital Universitaire Hop Huriez
Authority:
United States: Federal Government
Study ID:
CDR0000068128
NCT ID:
NCT00006115
Start Date:
April 1999
Completion Date:
Related Keywords:
- Colorectal Cancer
- stage IV colon cancer
- stage IV rectal cancer
- recurrent colon cancer
- recurrent rectal cancer
- adenocarcinoma of the colon
- adenocarcinoma of the rectum
- Colorectal Neoplasms
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