This trial is active, not recruiting.

Condition colorectal cancer
Treatments recombinant interferon alfa, fluorouracil, leucovorin calcium, levamisole hydrochloride
Phase phase 3
Sponsor European Institute of Oncology
Start date November 1991
Trial size 1050 participants
Trial identifier NCT00003063, CDR0000065728, CNR-TONE-01, EU-97011


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Primary purpose treatment

Eligibility Criteria

Male or female participants up to 75 years old.

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

Additional Information

Official title Adjuvant Chemoimmunotherapy for Colorectal Cancer
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).