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

NCT ID: NCT00043095

Last Updated: 2008-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-06-30

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Study Design

• Primary Study Purpose: TREATMENT

Interventions

gemcitabine hydrochloride

Intervention Type: DRUG

ixabepilone

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Sibyl Anderson, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

MSKCC-02012

Identifier Type: -

Identifier Source: secondary_id

NCI-5696

Identifier Type: -

Identifier Source: secondary_id

CDR0000256333

Identifier Type: -

Identifier Source: org_study_id