Flavopiridol and Irinotecan in Treating Patients With Advanced Solid Tumors

• 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 flavopiridol with irinotecan in treating patients who have locally advanced or metastatic solid tumors.

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

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Alvocidib; Camptothecin; Irinotecan

Criteria

DISEASE CHARACTERISTICS:

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

• Eligible for treatment at the maximum tolerated dose only if disease accessible for tissue biopsy by Tru-Cut, CT guidance, or endoscopy

• Pleural effusions or abdominal ascites do not constitute adequate tissue for biopsy

• No known CNS metastasis or primary CNS tumor

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,500/mm^3

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

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

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

• SGOT and SGPT no greater than 2.5 times upper limit of normal

Renal:

• Creatinine no greater than 1.5 mg/dL

Cardiovascular:

• No cardiac arrhythmias, congestive heart failure, or myocardial infarction within the past 6 months

Other:

• Not pregnant or nursing (during and for at least 2 months after study)

• Negative pregnancy test

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

• No concurrent serious or uncontrolled infection

• HIV negative

• No other medical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since prior immunotherapy and recovered

Chemotherapy:

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

• Prior irinotecan allowed

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 4 weeks since prior radiotherapy and recovered

Surgery:

• See Disease Characteristics

Other:

• Recovered from prior therapy

• No other concurrent investigational medication

• No concurrent vitamins (except a single multivitamin tablet), antioxidants, or herbal preparations or supplements

• No concurrent subcutaneous heparin or heparinoids