Flavopiridol, Gemcitabine, and Irinotecan in Treating Patients With Unresectable or Metastatic Solid Tumors

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

Summary

This phase I trial is studying the side effects and best dose of flavopiridol when given together with gemcitabine and irinotecan in treating patients with unresectable or metastatic solid tumors. Drugs used in chemotherapy, such as flavopiridol, gemcitabine, and irinotecan, work in 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; Gemcitabine; Irinotecan

Criteria

Inclusion Criteria:

• Histologically confirmed solid tumor that is metastatic or unresectable

• Standard curative or palliative measures do not exist or are no longer effective

• No known brain metastases

• Performance status - ECOG 0-2

• Performance status - Karnofsky 60-100%

• More than 12 weeks

• WBC ≥ 3,000/mm^3

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Bilirubin normal

• AST and ALT ≤ 2.5 times upper limit of normal

• Creatinine normal

• Creatinine clearance ≥ 60 mL/min

• No venous thrombosis within the past 6 months

• No thrombotic cerebrovascular accident within the past 6 months

• No myocardial infarction within the past 6 months

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

• No ongoing or active infection

• No prior allergic reaction attributed to compounds of similar chemical or biological composition to study agents

• No other concurrent uncontrolled medical condition that would preclude study participation

• No psychiatric illness or social situation that would preclude study participation

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Prior biologic therapy allowed

• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

• Prior endocrine therapy allowed

• More than 4 weeks since prior radiotherapy and recovered

• Prior surgery allowed

• No other concurrent investigational agents

• No concurrent combination antiretroviral therapy for HIV-positive patients