Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
unspecified adult solid tumor, protocol specific
Brief 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.
Detailed description
OBJECTIVES: * Determine the maximum tolerated dose, dose-limiting toxicity, and safety of BMS-247550 when combined with gemcitabine in patients with advanced solid tumors. * Determine the plasma pharmacokinetics of this regimen in this patient population. * Assess, preliminarily, any antitumor activity of this regimen in this patient population. OUTLINE: This is a dose-escalation study of BMS-247550. Patients receive gemcitabine IV over 90 minutes on days 1 and 8 followed by BMS-247550 IV over 3 hours on day 8. The order of chemotherapy drug administration on day 8 is reversed during the second course only. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of BMS-247550 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 9 patients total are treated at the MTD. PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study.
Interventions
DRUGgemcitabine hydrochloride
DRUGixabepilone
Sponsors
National Cancer Institute (NCI)
Memorial Sloan Kettering Cancer Center
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Countries
United States
Outcome results
None listed