Comparison of Combination Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more tumor cells. PURPOSE: This randomized phase II trial is studying combination chemotherapy containing irinotecan and oxaliplatin to see how well it works compared to two standard combination chemotherapy regimens in treating patients with unresectable metastatic colorectal cancer.

Detailed Description
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OBJECTIVES: Compare the efficacy, in terms of response rate (partial response and complete response), of irinotecan and oxaliplatin vs irinotecan, fluorouracil, and leucovorin calcium vs oxaliplatin, fluorouracil, and leucovorin calcium in patients with metastatic colorectal cancer. Compare the progression-free survival of patients treated with these regimens. Compare the tolerability of these regimens in these patients. Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms. Arm I: Patients receive irinotecan IV over 90 minutes and oxaliplatin IV over 2 hours on day 1. Arm II: Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours on days 1-2. Arm III: Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours on days 1-2. In all arms, treatment repeats every 2 weeks for 26 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then every 3 months for 1 year. Patients are followed at 2 months. PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 1 year.

Official Title
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Randomized Phase II Study Evaluating Three Chemotherapies: [Irinotecan + Oxaliplatin (Irinox)], [Irinotecan + LV5FU2] and [Oxaliplatin + LV5FU2] as First Intention Treatment in Subjects With Metastatic Colorectal Cancer

Conditions
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Colorectal Cancer

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


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed colorectal carcinoma Metastatic disease Not amenable to surgery Unidimensionally measurable disease No bone metastases No brain metastases PATIENT CHARACTERISTICS: Age 18 to 75 Performance status WHO 0-2 Life expectancy At least 12 weeks Hematopoietic Neutrophil count at least 2,000/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10 g/dL Hepatic Bilirubin no greater than 1.25 times upper limit of normal (ULN) (1.5 times ULN if hepatic metastases are present) SGPT and SGOT no greater than 3 times ULN (5 times ULN if hepatic metastases are present) Renal Creatinine no greater than 1.25 times ULN Cardiac No concurrent cardiac abnormalities that would preclude study therapy Pulmonary No concurrent pulmonary abnormalities that would preclude study therapy Other Not pregnant or nursing Fertile patients must use effective contraception No chronic enteropathy No other prior cancer within the past 5 years except carcinoma in situ of the cervix or curatively treated basal cell skin cancer No concurrent severe uncontrolled infection No obstruction or partial obstruction that would interfere with study therapy No psychological, social, familial, or geographical situation that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent anticancer biological response modifiers Chemotherapy No prior chemotherapy (except adjuvant chemotherapy completed more than 6 months ago) No prior irinotecan No prior oxaliplatin No other concurrent chemotherapy Endocrine therapy No concurrent anticancer hormonal therapy Radiotherapy At least 4 weeks since prior pelvic radiotherapy No prior abdominopelvic radiotherapy Surgery At least 4 weeks since prior surgery No prior extensive intestinal resection (i.e., more than 1 prior hemicolectomy or extensive resection of the small intestines) Other No other concurrent experimental medication No other concurrent anticancer therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Allocation: Randomized


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 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