BMS-247550 and Gemcitabine in Treating Patients With Advanced Solid Tumors

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase I Trial of BMS 247550 (NSC# 710428) and Gemcitabine in Patients With Advanced Solid Tumor Malignancies

Conditions
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Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: gemcitabine hydrochloride
* Drug: ixabepilone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: gemcitabine hydrochloride|nan|
|Drug: ixabepilone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unspecified adult solid tumor, protocol specific