Overview

Monoclonal Antibody Therapy Plus Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer

Status:
Completed
Trial end date:
2002-08-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Monoclonal antibodies can find and locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and combining chemotherapy with monoclonal antibody therapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy plus combination chemotherapy in treating patients with advanced colorectal cancer.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Antibodies
Antibodies, Monoclonal
Carmustine
Fluorouracil
Immunoglobulins
Streptozocin
Vincristine
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed unresectable stage IV colon or rectal
cancer that has failed conventional chemotherapy for advanced disease or refused other
treatment Measurable disease No liver involvement of greater than 50% No clinical evidence
of CNS tumor involvement

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80-100% Life
expectancy: At least 14 weeks Hematopoietic: WBC at least 3,5000/mm3 Platelet count at
least 150,000/mm3 Hepatic: Bilirubin no greater than 1.0 mg/dL Renal: Creatinine no greater
than 1.5 mg/dL Cardiovascular: No clinically significant cardiac disease (New York Heart
Association class III/IV heart disease) Other: No positive human antimouse antibody titer
No serious infection requiring treatment with antibiotics No other serious illness Not
pregnant or nursing Effective contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior mouse monoclonal antibody or antibody
fragment, or chimeric or humanized antibody At least 4 weeks since prior immunotherapy
Chemotherapy: No prior carmustine, fluorouracil, vincristine, and streptozocin At least 4
weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4
weeks since prior radiotherapy Surgery: Not specified