Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer

Study Overview
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Brief Summary
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RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy with biological therapy may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of treatment using levamisole with treatment using interferon alfa and combination chemotherapy consisting of fluorouracil and leucovorin in patients with stage II or stage III colorectal cancer.

Detailed Description
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OBJECTIVES: Assess the efficacy of the addition of levamisole or alfa interferon to fluorouracil and leucovorin calcium (folinic acid) as an adjuvant treatment of intraperitoneal colorectal cancer. OUTLINE: This is a three arm study. Patients are randomized to receive either levamisole, alfa interferon, or no treatment. Arm I: Patients receive levamisole PO for 3 days every 2 weeks for 6 months before and after surgery. Fluorouracil IV bolus and leucovorin calcium (folinic acid) IV over 1 hour are administered on days 1-5 every 4 weeks for 6 cycles after surgery. Arm II: Patients receive alfa interferon-2a SC on 3 alternate days for a week before surgery and for 6 months after surgery. Fluorouracil IV bolus and folinic acid IV over 1 hour are administered on days 1-5 every 4 weeks for 6 cycles after surgery. Arm III: Patients undergo surgery followed by fluorouracil IV bolus and folinic acid IV over 1 hour on days 1-5 every 4 weeks for 6 cycles. Patients are followed every 3 months for 2 years, then every 6 months. PROJECTED ACCRUAL: 350 patients per arm will be accrued for a total of 1,050 patients.

Official Title
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Adjuvant Chemoimmunotherapy for Colorectal Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Biological: recombinant interferon alfa
* Drug: fluorouracil
* Drug: leucovorin calcium
* Drug: levamisole hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed stage T3-T4 N0 or T1-T4 N1-3 colorectal cancer No evidence of residual disease after surgery Tumor located above peritoneal reflection No distant metastases PATIENT CHARACTERISTICS: Age: 75 and under Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 3500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL SGPT less than 2 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No serious cardiac ischemia Other: Adequate metabolic functions No prior neoplasm No prior/concurrent illness No insulin-dependent diabetes PRIOR CONCURRENT THERAPY: Biologic therapy No prior immunotherapy for the current cancer Chemotherapy No prior chemotherapy for the current cancer Endocrine therapy Not specified Radiotherapy No prior radiotherapy for the current cancer Surgery Not specified

Ages Eligible for Study
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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 |
| --- |
|Biological: recombinant interferon alfa|nan|
|Drug: fluorouracil|nan|
|Drug: leucovorin calcium|nan|
|Drug: levamisole hydrochloride|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 II colon cancer, stage III colon cancer, stage II rectal cancer, stage III rectal cancer