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A Phase II Study of the Safety, Efficacy and Pharmacokinetics of VX-710 in Combination With Doxorubicin and Vincristine in Patients With Small Cell Lung Cancer (SCLC) (NCT00003847)

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 II trial to study the effectiveness of combination chemotherapy for the treatment of patients who have recurrent small cell lung cancer following treatment.
  • Drug: biricodar dicitrate
    • Drug: doxorubicin hydrochloride
      • Drug: vincristine sulfate
        Ages eligible for Study
        18 Years and older
        Genders eligible for Study
        All
        Accepts Healthy Volunteers
        No
        OBJECTIVES: I. Established the safety of VX-710 in combination with doxorubicin and vincristine for the treatment of patients with recurrent small cell lung cancer. II. Characterized the plasma pharmacokinetics of this regimen in patients. III. Established the ability of this regimen to improve the response rate to chemotherapy in patients who relapsed on front-line therapy. IV. Evaluated the multidrug resistance profile of these patients following this treatment regimen.

        OUTLINE: This was a multicenter study. Stage I: Patients received VX-710 IV over 72 hours, followed by doxorubicin IV and vincristine IV four hours after initial VX-710. Vincristine was administered at half dose in the first 3-6 patients. If no more than 1 of 6 patients experienced a dose limiting toxicity in the half dose cohort, 3 additional patients received full dose vincristine. The maximum tolerated dose was defined as the dose preceding that at which 2 of 6 patients experienced a dose limiting toxicity. Stage II: Patients received VX-710 IV over 72 hours, followed by doxorubicin IV and full dose vincristine IV four hours after initial VX-710. Treatment continued for up to 6 courses every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients were followed every 3 months for up to 1 year.

        PROJECTED ACCRUAL: A minimum of 35 and a maximum of 92 patients was to be accrued for this study.

        9 locations

        United States (9)
        • University of Arkansas for Medical Sciences
          Little Rock, Arkansas, United States, 72205
        • Indiana University Cancer Center
          Indianapolis, Indiana, United States, 46202-5265
        • Massachusetts General Hospital Cancer Center
          Boston, Massachusetts, United States, 02114
        • Dana-Farber Cancer Institute
          Boston, Massachusetts, United States, 02115
        • Fallon Clinic Inc.
          Worcester, Massachusetts, United States, 01605
        • St. John's Mercy Medical Center
          Saint Louis, Missouri, United States, 63141
        • Roswell Park Cancer Institute
          Buffalo, New York, United States, 14263-0001
        • Duke Comprehensive Cancer Center
          Durham, North Carolina, United States, 27710
        • Fox Chase Cancer Center
          Philadelphia, Pennsylvania, United States, 19111
        Status:
        terminated
        Type:
        Interventional
        Phase:
        Start:
        30 November, 1998
        Updated:
        03 September, 2013
        Participants:
        36
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