Overview

Chemotherapy With Raltitrexed and Fluorouracil in Treating Patients With Advanced Colorectal Cancer

Status:
Completed
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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of raltitrexed and fluorouracil in treating patients who have colorectal cancer that is metastatic, recurrent, or cannot be surgically removed.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Treatments:
Fluorouracil
Raltitrexed
Criteria
DISEASE CHARACTERISTICS: Histologically proven metastatic, locally recurrent, or surgically
unresectable colorectal carcinoma Measurable disease No CNS metastasis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: Not
specified Hematopoietic: Absolute neutrophil count at least 2,000/mm3 Platelet count at
least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 2.5
times normal (5 times normal if known liver metastases) Renal: Creatinine no greater than
1.5 mg/dL Other: No severe concurrent infection Not pregnant or nursing Negative pregnancy
test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than 1
prior chemotherapy regimen Prior fluorouracil-based regimen for advanced colorectal cancer
allowed Prior fluorouracil with radiotherapy not considered therapy for advanced disease At
least 4 weeks since prior chemotherapy (8 weeks for mitomycin or nitrosoureas) and
recovered Endocrine therapy: No concurrent steroids except for antiemesis or as replacement
therapy Radiotherapy: See Chemotherapy No prior radiotherapy to more than 30% of bone
marrow Surgery: See Disease Characteristics At least 4 weeks since prior surgery unless
fully recovered Other: No concurrent vitamin supplements containing folic acid No other
concurrent anticancer therapy