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BMS-247550 in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Therapy

Sponsor
R-Pharm (Industry)
Overall Status
Completed
CT.gov ID
NCT00004927
Collaborator
National Cancer Institute (NCI) (NIH), Memorial Sloan Kettering Cancer Center (Other)
2
Locations
39
Duration (Months)

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of BMS-247550 in treating patients who have advanced solid tumors that have not responded to previous therapy.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

OBJECTIVES: I. Determine the maximum tolerated dose, dose limiting toxicities, safety, and a recommended phase II dose of BMS-247550 administered as a 1 hour infusion every 3 weeks in patients with advanced solid tumors. II. Evaluate the plasma pharmacokinetics of this drug in this patient population. III. Determine any preliminary evidence of antitumor activity of this drug in these patients.

OUTLINE: This is a dose escalation study. Patients receive BMS-247550 IV over 1 hour every 3 weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression. 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 2 of 3 or 2 of 6 patients experience dose limiting toxicities. Patients are followed every 3 months until death.

PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study within 8-12 months.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
Phase I Study of BMS-247550 Given Every Three Weeks in Patients With Advanced Malignancies
Study Start Date :
Jul 1, 1999
Actual Primary Completion Date :
Oct 1, 2002
Actual Study Completion Date :
Oct 1, 2002

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced solid tumor that has failed standard therapy or for which no standard therapy exists No hematological malignancies allowed Measurable or evaluable disease Must have clinical or radiological evidence of disease No active brain metastases including evidence of cerebral edema by CT or MRI, or progression from prior imaging study, any requirement for steroids, or clinical symptoms of/from brain metastases

    PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL AST/ALT no greater than 2.5 times upper limit of normal (ULN) Renal: Creatinine less than 1.5 times ULN Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No preexisting peripheral neuropathy greater than grade 1 due to any cause No documented hypersensitivity reaction grade 2 or greater to prior paclitaxel or other therapy containing Cremophor EL No serious uncontrolled medical disorder or active infection that would preclude protocol therapy No dementia or altered mental status that would preclude compliance HIV negative

    PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy No concurrent biologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, and doxorubicin HCl liposome) Prior taxanes allowed No more than 2 prior chemotherapy regimens in metastatic setting Prior adjuvant/neoadjuvant chemotherapy allowed No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics No concurrent hormonal therapy (except hormone replacement therapy or medication to maintain castrate status) Radiotherapy: At least 4 weeks since prior radiotherapy No prior radiotherapy to greater than 25% of bone marrow No concurrent radiotherapy Surgery: No concurrent surgery Other: At least 4 weeks since other prior investigational agents No other concurrent experimental anticancer medications No other concurrent specific antitumor therapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201
    2 Memorial Sloan-Kettering Cancer Center New York New York United States 10021

    Sponsors and Collaborators

    • R-Pharm
    • National Cancer Institute (NCI)
    • Memorial Sloan Kettering Cancer Center

    Investigators

    • Study Chair: David R. Spriggs, MD, Memorial Sloan Kettering Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    R-Pharm
    ClinicalTrials.gov Identifier:
    NCT00004927
    Other Study ID Numbers:
    • BMS-CA163-001
    • MSKCC-99052
    • CDR0000067611
    • NCI-87
    • NCI-G00-1698
    • MAYO-C2072
    First Posted:
    Jun 4, 2004
    Last Update Posted:
    Jan 30, 2017
    Last Verified:
    Jan 1, 2017
    Keywords provided by R-Pharm
    unspecified adult solid tumor, protocol specific

    Study Results

    No Results Posted as of Jan 30, 2017