Combination Chemotherapy in Treating Patients With Advanced Cancer

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

Summary

Phase I trial to study the effectiveness of combining flavopiridol, fluorouracil, and leucovorin with or without irinotecan in treating patients who have advanced cancer. 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Alvocidib; Calcium; Camptothecin; Fluorouracil; Irinotecan; Leucovorin; Levoleucovorin

Criteria

Inclusion Criteria:

• Histologically confirmed malignancy

• Unresectable tumor

• No known standard therapy with curative potential or capability of extending life expectancy

• No untreated CNS metastases

• Performance status - ECOG 0-2

• At least 12 weeks

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 8 g/dL

• Direct bilirubin no greater than upper limit of normal (ULN)

• AST no greater than 3 times ULN (5 times ULN if liver metastases present)

• Creatinine no greater than 1.5 times ULN

• No New York Heart Association class III or IV heart disease

• No seizure disorder

• No uncontrolled infection

• No baseline diarrhea, defined as at least 4 loose or liquid stools/day

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• More than 4 weeks since prior biologic therapy

• More than 4 weeks since prior immunotherapy

• No concurrent immunotherapy

• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and fully recovered from acute reversible effects

• No other concurrent chemotherapy

• More than 4 weeks since prior radiotherapy

• No prior radiotherapy to more than 25% of bone marrow

• No concurrent radiotherapy

• No other concurrent ancillary investigational therapy