Combination Chemotherapy in Treating Patients With Advanced Solid Tumors

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

Summary

Phase I trial to study the effectiveness of combining alvocidib, irinotecan hydrochloride, and cisplatin in treating patients who have advanced solid tumors. 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; Camptothecin; Cisplatin; Irinotecan

Criteria

Inclusion Criteria:

• Histologically confirmed locally advanced or metastatic solid tumor that is refractory to standard therapy or for which no standard therapy exists

• Evaluable disease

• No previously untreated CNS metastasis

• No primary CNS tumors

• Performance status - Karnofsky 60-100%

• Performance status - ECOG 0-2

• Not specified

• WBC at least 3,000/mm^3

• Neutrophil count at least 1,500/mm^3

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

• Bilirubin no greater than 2.0 mg/dL

• AST and ALT no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)

• Creatinine no greater than 1.5 mg/dL

• Creatinine clearance at least 60 mL/min

• No cardiac arrhythmia

• No congestive heart failure

• No myocardial infarction within the past 6 months

• HIV negative

• No neuropathy grade 2 or greater

• No serious or uncontrolled infection

• No other medical condition or reason that would preclude study participation

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for at least 2 months after study participation

• At least 4 weeks since prior immunotherapy

• At least 1 week since prior irinotecan and cisplatin alone

• At least 4 weeks since other prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

• Not specified

• At least 4 weeks since prior radiotherapy

• Not specified

• Recovered from all prior therapy

• No concurrent vitamins, antioxidants, or herbal supplements except a daily multivitamin

• No other concurrent investigational drugs