This trial is active, not recruiting.

Condition colorectal cancer
Treatments folfiri regimen, fluorouracil, irinotecan hydrochloride, leucovorin calcium
Phase phase 2
Sponsor Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Start date June 2002
Trial identifier NCT00075595, CDR0000347378, EU-20333, FRE-GERCOR-FOLFIRI3-C00-2


RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and irinotecan, use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving fluorouracil together with leucovorin and irinotecan works in treating patients with recurrent or refractory metastatic unresectable colorectal cancer.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Time to progression
time frame:
Time to death from progression
time frame:

Secondary Outcomes

Objective response
time frame:
Stabilization rate
time frame:
Time to treatment failure
time frame:
Duration of response
time frame:
Overall survival rate
time frame:
Incidence of grade 3 or 4 toxicity
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

DISEASE CHARACTERISTICS: - Histologically confirmed colorectal adenocarcinoma - Metastatic, unresectable disease - Meets 1 of the following criteria: - At least 1 unidimensionally measurable metastatic lesion at least 10 mm by spiral scan OR 20 mm by conventional scan - Evaluable disease - Evidence of disease (e.g., ascites or bone metastases) by imaging techniques - Progressive disease as defined by 1 of the following criteria: - Progressive disease while receiving first-line chemotherapy - Recurrent disease within 6 months after completing adjuvant chemotherapy - No symptomatic brain metastases PATIENT CHARACTERISTICS: Age - 18 to 80 Performance status - WHO 0-2 Life expectancy - At least 3 months Hematopoietic - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 Hepatic - Bilirubin < 1.5 times upper limit of normal (ULN) - Alkaline phosphatase < 3 times ULN Renal - Not specified Cardiovascular - No uncontrolled angina - No myocardial infarction within the past 6 months Gastrointestinal - No chronic diarrhea grade 2 or greater - No unresolved fully or partially obstructed intestine Other - Not pregnant or nursing - Fertile patients must use effective contraception - No other underlying disease or medical condition that would preclude study participation - No other prior malignancy except curatively treated basal cell cancer or carcinoma in situ of the cervix - No psychological, social, familial, or geographical condition that would preclude study follow-up PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics - No prior irinotecan Endocrine therapy - Not specified Radiotherapy - At least 3 weeks since prior radiotherapy Surgery - At least 3 weeks since prior surgery Other - No other concurrent clinical trial participation

Additional Information

Official title Phase II Study of 5FU/Folinic Acid and Irinotecan as Second or Third Line Treatment in Patients With Metastatic, Unresectable, Colorectal Cancer
Description OBJECTIVES: Primary - Determine the time to progression and time to death from progression in patients with recurrent or refractory metastatic unresectable colorectal cancer treated with fluorouracil, leucovorin calcium, and irinotecan. Secondary - Determine the objective response and stabilization rate in patients treated with this regimen. - Determine the time to treatment failure in patients treated with this regimen. - Determine the duration of response in patients treated with this regimen. - Determine overall survival rate in patients treated with this regimen. - Determine the incidence of grade 3 or 4 toxicity in patients treated with this regimen. OUTLINE: This is an open-label, multicenter study. Patients receive leucovorin calcium IV over 2 hours on day 1, irinotecan IV over 1 hour on days 1 and 3, and fluorouracil IV continuously over 46 hours beginning on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 78 patients will be accrued for this study within 18 months.
Trial information was received from ClinicalTrials.gov and was last updated in January 2009.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).