BMS-247550 and Gemcitabine 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 BMS-247550 with gemcitabine in treating patients who have advanced solid tumors.

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

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Gemcitabine

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-hematological cancer that is unresponsive to currently available therapies or for which there is no known effective treatment

• Clinical or radiological evidence of disease required

• No active brain metastases, including evidence of cerebral edema (by CT scan or MRI), progression from prior imaging study, any requirement for steroids, or clinical symptoms

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 greater than 100,000/mm^3

• Hemoglobin at least 8.0 g/dL

Hepatic

• Bilirubin no greater than 1.5 mg/dL

• ALT and AST no greater than 2.5 times upper limit of normal (ULN) or 93 U/L

Renal

• Creatinine no greater than 1.5 times ULN or 2.0 mg/dL

Other

• No documented hypersensitivity reaction to prior paclitaxel or other therapy containing Cremophor EL

• No grade 2 or greater pre-existing peripheral neuropathy

• No serious uncontrolled medical disorder or active infection that would preclude study therapy

• No dementia or altered mental status that would preclude informed consent

• 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

Chemotherapy

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or doxorubicin HCl liposome)

• Prior taxanes allowed

• Prior adjuvant or neoadjuvant chemotherapy allowed

• No more than 2 prior chemotherapy regimens in the metastatic setting

• No other concurrent chemotherapy

Endocrine therapy

• See Disease Characteristics

• No concurrent hormonal therapy except hormone-replacement therapy

• Concurrent medications to maintain castrate status for progressive hormone-refractory prostate cancer allowed

Radiotherapy

• At least 4 weeks since prior radiotherapy

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

• No concurrent radiotherapy

Surgery

• Not specified

Other

• At least 4 weeks since prior investigational agents

• No other concurrent experimental anticancer medications

• No concurrent alternative therapies (e.g., high-dose vitamins or herbal medicines)

• No concurrent combination antiretroviral therapy for HIV-positive patients