Overview

Combination Chemotherapy in Treating Patients With Advanced Cancer

Status:
Completed
Trial end date:
1969-12-31
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 combining topotecan, fluorouracil, and leucovorin in treating patients who have advanced cancer.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
New York University School of Medicine
NYU Langone Health
Collaborator:
National Cancer Institute (NCI)
Treatments:
Calcium
Fluorouracil
Leucovorin
Levoleucovorin
Topotecan
Criteria
DISEASE CHARACTERISTICS: Histologically proven advanced malignancy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 3 months Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet
count greater than 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL SGOT less than 3
times upper limit of normal (ULN) (less than 5 times ULN if due to hepatic metastases) LDH
less than 3 times ULN (less than 5 times ULN if due to hepatic metastases) Alkaline
phosphatase less than 3 times ULN (less than 5 times ULN if due to hepatic metastases)
Renal: Creatinine no greater than 1.5 mg/dL Other: No active infection requiring systemic
therapy within 1 week prior to entry No significant concurrent illness No history of
bleeding disorder or clotting factor deficiency No dementia or altered mental status that
would prohibit informed consent Not pregnant or nursing Effective contraception strongly
advised for fertile women

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent colony stimulating factors during
topotecan infusion Chemotherapy: At least 3 weeks since prior chemotherapy No more than 3
prior chemotherapy regimens Endocrine therapy: Not specified Radiotherapy: At least 3 weeks
since prior radiotherapy Surgery: Not specified