Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	NCI	MSKCC-02012 NCI-5696, NCT00043095, 5696

Objectives

1. Determine the maximum tolerated dose, dose-limiting toxicity, and safety of BMS-247550 when combined with gemcitabine in patients with advanced solid tumors.
2. Determine the plasma pharmacokinetics of this regimen in this patient population.
3. Assess, preliminarily, any antitumor activity of this regimen in this patient population.

Entry 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

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

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/mm³
• Platelet count greater than 100,000/mm³
• 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

Expected Enrollment

A maximum of 40 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Sibyl Anderson, MD, Protocol chair		Ph: 212-639-6555; 800-525-2225

Registry Information
Official Title		A Phase I Trial of BMS 247550 (NSC# 710428) and Gemcitabine in Patients with Advanced Solid Tumor Malignancies
Trial Start Date		2002-06-18
Registered in ClinicalTrials.gov		NCT00043095
Date Submitted to PDQ		2002-06-21
Information Last Verified		2005-04-06
NCI Grant/Contract Number		U01-CA69856, P30-CA08748

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