Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Institute of Oncology
• Treatments: Calcium; Fluorouracil; Interferon-alpha; Interferons; Leucovorin; Levamisole; Levoleucovorin

Criteria

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