Expired Study
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New York, New York 10021


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00043095


Primary Contact:

Study Chair
Sibyl Anderson, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 10, 2017

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