Multicentre Phase III Comparing To Therapeutic Sequence: Folfiri Following of Folfox6 (Group A) and Folfox6 Following Of (Group B) For Metastatic Colorectal Cancer
18 Years
75 Years
Both
Colorectal Cancer
Trial Information
Multicentre Phase III Comparing To Therapeutic Sequence: Folfiri Following of Folfox6 (Group A) and Folfox6 Following Of (Group B) For Metastatic Colorectal Cancer
OBJECTIVES: I. Compare the efficacy of leucovorin calcium plus fluorouracil with either
irinotecan or oxaliplatin in terms of progression free survival in patients with recurrent
metastatic colorectal cancer. II. Compare the efficacy, tolerance, quality of life, and
overall survival in this patient population.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating
institution and measurable or evaluable disease. Patients are randomized to receive either a
2 hour continuous infusion of irinotecan or a 2 hour continuous infusion of oxaliplatin on
day 1. All patients receive a 2 hour continuous infusion of leucovorin calcium followed by
IV bolus and 48 hour continuous infusion of fluorouracil on days 1 and 2. Courses are
repeated every 2 weeks. Patients will receive the alternate treatment if disease progression
or unacceptable toxicity occurs on their initial treatment. Patients are followed every 3
months after end of treatment.
PROJECTED ACCRUAL: This study will accrue a total of 109 patients per arm over approximately
18 months.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically proven recurrent stage IV adenocarcinoma of the
colon and rectum No CNS metastases Bidimensionally measurable lesion (at least 2 cm in
dimension) or evaluable disease (as malignant ascites or bone metastases) as documented by
CT or MRI Must be outside prior radiotherapy field
PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: WHO 0-2 Life expectancy:
Greater than 3 months Hematopoietic: Absolute neutrophil count greater than 1,500/mm3
Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times
normal Alkaline phosphatase no greater than 3 times normal SGOT/SGPT no greater than 3
times normal Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No uncontrolled
congestive heart failure or angina pectoris in the past 6 months No hypertension or
arrhythmia in the past 6 months Neurologic: No peripheral neuropathy No significant
neurologic or psychiatric disorder Other: No complete or partial obstruction of the bowel
No serious nonmalignant disease No active infection No second malignancy except in situ
cervical carcinoma or nonmelanomatous skin carcinoma No chronic diarrhea Not pregnant or
nursing Fertile women must use adequate contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy for metastatic disease
Chemotherapy: No prior chemotherapy for metastatic disease At least 6 months since prior
adjuvant chemotherapy with no disease progression or after metastatic liver resection No
prior chemotherapy with oxaliplatin or irinotecan Endocrine therapy: Not specified
Radiotherapy: At least 2 weeks since prior radiotherapy Surgery: At least 2 weeks since
surgery Other: At least 30 days since use of investigational agent
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Aimery de Gramont, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Hopital Saint Antoine
Authority:
United States: Federal Government
Study ID:
CDR0000066151
NCT ID:
NCT00003260
Start Date:
January 1998
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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