Chemotherapy Plus IM-862 in Treating Patients With Metastatic Colorectal Cancer

• Status: Terminated
• Trial end date: 2001-11-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. IM-862 may stop the growth of colorectal cancer by stopping blood flow to the tumor. It is not yet known if chemotherapy is more effective with or without IM-862 in treating colorectal cancer.

PURPOSE: Randomized phase II trial to study the effectiveness of chemotherapy plus IM-862 in treating patients who have metastatic colorectal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Southern California
• Collaborator: National Cancer Institute (NCI)
• Treatments: Fluorouracil; Irinotecan; Thymogen

Criteria

DISEASE CHARACTERISTICS: Histologically proven metastatic adenocarcinoma of the colon or rectum Previously untreated OR Recurrent with a disease free period of at least 1 year Measurable or evaluable disease Tumor must be accessible for biopsy No brain metastasis

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count greater than 1,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) (no greater than 3 times ULN if liver metastasis present) AST or ALT no greater than 2 times ULN (no greater than 5 times ULN if liver metastasis present) Renal: Creatinine no greater than 1.25 times ULN Cardiovascular: No myocardial infarction within the past year No congestive heart failure Other: No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 6 months after study No medical, social, or psychological factor that would interfere with compliance

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior adjuvant immunotherapy with monoclonal antibody 17-1A allowed No prior IM-862 Chemotherapy: At least 1 year since prior chemotherapy for patients with recurrent metastatic adenocarcinoma of the colon or rectum Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy No concurrent radiotherapy Surgery: Not specified