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BMS-214662 in Treating Patients With Solid Tumors

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00005973
Collaborator
(none)
36
Enrollment
1
Location
1
Arm

Study Details

Study Description

Brief Summary

Phase I trial to study the effectiveness of BMS-214662 in treating patients who have solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

OBJECTIVES:

  1. Determine the maximum tolerated dose of BMS-214662 in patients with solid tumors.

  2. Evaluate intermediate biological endpoints as surrogates for the effectiveness of this drug in these patients.

  3. Determine the nature of dose limiting toxicity of this drug in this patient population.

  4. Determine the recommended phase II regimen of this drug in these patients. V. Establish a pharmacologic and pharmacokinetic profile of this drug in these patients.

OUTLINE: This is a dose escalation study.

Patients receive BMS-214662 IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of BMS-214662 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicities.

Patients are followed every 3 months for at least 24 months.

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I Study of Farnesyl Transferase Inhibitor BMS-214662 (NSC 710086D) in Solid Tumors
Study Start Date :
Apr 1, 2000
Actual Primary Completion Date :
Jul 1, 2004

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment

Patients receive BMS-214662 IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

Drug: BMS-214662
Given IV
Other Names:
  • farnesyltransferase inhibitor BMS-214662
  • FTI BMS 214662

    • Other: laboratory biomarker analysis
    Correlative studies

    Outcome Measures

    Primary Outcome Measures

    1. MTD, defined as the dose level among the 9 levels studied having toxicity rate closest to a target of 33%, graded according to CTC version 2.0 [Up to 6 weeks]

      Toxicity is defined as grade 3, 4 non-hematologic and grade 4 hematologic (neutropenia and thrombocytopenia) toxicity. The continual reassessment method (CRM) will be used.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosis of malignant solid tumor for which a standard curative therapy does not exist

    • Performance status - Karnofsky 70-100%

    • At least 6 months

    • WBC at least 3,000/mm^3

    • Absolute neutrophil count at least 1,500/mm^3

    • Platelet count at least 100,000/mm^3

    • Hemoglobin at least 10.0 g/dL

    • Bilirubin no greater than 2.0 mg/dL

    • AST no greater than 2 times upper limit of normal

    • Albumin at least 3.0 g/dL

    • Creatinine no greater than 1.5 mg/dL

    • No uncontrolled heart disease

    • No history of clinically significant cardiac arrhythmia that could be exacerbated by QT interval prolongation

    • Corrected QT interval no greater than 450 milliseconds

    • Must not require total parenteral nutrition

    • No manifestations of malabsorption syndrome due to prior surgery, gastrointestinal disease, or unknown reasons

    • Not pregnant or nursing

    • Negative pregnancy test

    • Fertile patients must use effective contraception

    • No signs or symptoms of acute infection requiring systemic therapy

    • No grade 3 or 4 neurotoxicity from prior anticancer treatment or neuropathy from any cause

    • No confusion, disorientation, or psychiatric illness that may preclude study

    • No more than 3 prior chemotherapy regimens

    • At least 4 weeks since prior chemotherapy (6 weeks since prior nitrosoureas or mitomycin) and recovered

    • No other concurrent antineoplastic agents

    • No concurrent hormonal anticancer therapy

    • At least 4 weeks since prior radiotherapy

    • No concurrent radiotherapy

    • Prior drugs known to prolong the QT interval allowed if they can be safely discontinued for a time period equal to 4 elimination half-lives prior to administering study drug

    • No drugs known to prolong the QT interval during and for 24 hours after study drug

    • No concurrent therapy with known CYP3A4 substrates

    • No other concurrent investigational agents

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 M D Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Vassiliki Papadimitrakopoulou, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00005973
    Other Study ID Numbers:
    • NCI-2012-02343
    • ID99-304
    • U01CA062461
    • CDR0000067960
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Jan 23, 2013
    Last Verified:
    Jan 1, 2013
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Jan 23, 2013