Fluorouracil, Leucovorin, and Irinotecan in Treating Patients With Recurrent or Refractory Metastatic Unresectable Colorectal Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase II Study of 5FU/Folinic Acid and Irinotecan as Second or Third Line Treatment in Patients With Metastatic, Unresectable, Colorectal Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: FOLFIRI regimen
* Drug: fluorouracil
* Drug: irinotecan hydrochloride
* Drug: leucovorin calcium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: FOLFIRI regimen|nan|
|Drug: fluorouracil|nan|
|Drug: irinotecan hydrochloride|nan|
|Drug: leucovorin calcium|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression |  |  | 
| Time to death from progression |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response |  |  | 
| Stabilization rate |  |  | 
| Time to treatment failure |  |  | 
| Duration of response |  |  | 
| Overall survival rate |  |  | 
| Incidence of grade 3 or 4 toxicity |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum