bms-247550 and gemcitabine in treating patients with advanced solid tumors

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

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.

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.

Eligibility 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

Keywords: unspecified adult solid tumor, protocol specific