BMS-188797 and Carboplatin in Treating Patients With Advanced Nonhematologic 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 BMS-188797 and carboplatin in treating patients who have advanced nonhematologic cancer.

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

Details

• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carboplatin

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed advanced nonhematologic malignancy that has progressed on standard therapy or for which no curative therapy exists

• No brain metastases

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• At least 3 months

Hematopoietic:

• Absolute 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

• ALT and AST no greater than 2.5 times upper limit of normal (ULN) unless due to hepatic metastases

Renal:

• Creatinine no greater than 1.5 times ULN

Other:

• No chronic medical condition requiring treatment with corticosteroids

• No prior severe hypersensitivity reaction to agents containing Cremophor (polyoxyethylated castor oil)

• No serious uncontrolled medical disorder, active infection, or psychiatric disorder (e.g., dementia) that would preclude study

• No preexisting neurotoxicity grade 1 or greater

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since prior immunotherapy and recovered

• No concurrent immunotherapy

Chemotherapy:

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

• No more than 2 prior chemotherapy regimens for metastatic disease

• No prior platinum or taxane therapy

• No other concurrent chemotherapy

Endocrine therapy:

• At least 2 weeks since prior hormonal therapy (except megestrol for anorexia/cachexia) and recovered

• At least 7 days since prior corticosteroids

• No concurrent corticosteroids

• No concurrent hormonal therapy

Radiotherapy:

• At least 4 weeks since prior radiotherapy to 30% or more of bone marrow and recovered

• No concurrent radiotherapy

Surgery:

• Not specified

Other:

• No other concurrent investigational drug