Paclitaxel + Carboplatin With/ut BMS-275291 in Advanced or Metastatic Non-small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. It is not yet known whether paclitaxel and carboplatin are more
      effective with or without BMS-275291 for non-small cell lung cancer.

      PURPOSE: Randomized phase II/III trial to compare the effectiveness of paclitaxel and
      carboplatin with or without BMS-275291 in treating patients who have advanced or metastatic
      non-small cell lung cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the overall survival of patients with advanced or metastatic non-small cell lung
           cancer treated with paclitaxel and carboplatin with or without BMS-275291.

        -  Compare the incidence of grade 2 or higher drug related arthritis, arthralgia and/or
           myalgia in patients treated with these regimens. (Phase II only)

        -  Compare the objective tumor response rate, time to response, and response duration in
           patients treated with these regimens.

        -  Compare the nature, severity, and frequency of toxic effects of these regimens in these
           patients.

        -  Compare the progression free survival of patients treated with these regimens. (Phase
           III only)

        -  Correlate the expression of serum/plasma and tissue matrix metalloproteinases (MMP)
           levels and other markers with outcomes and response in patients treated with these
           regimens.

        -  Compare quality of life of patients treated with these regimens.

      OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients
      are stratified according to center, disease stage (IIIB vs IV), and ECOG performance status
      (0-1 vs 2). Patients are randomized to one of two treatment arms.

        -  Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on
           day 1 plus oral BMS-275291 daily on days 1-21.

        -  Arm II: Patients receive paclitaxel and carboplatin as in arm I plus oral placebo daily
           on days 1-21.

      Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or
      unacceptable toxicity. BMS-275291 or placebo continues beyond 8 courses in the absence of
      disease progression.

      Quality of life is assessed.

      Patients are followed every 3 months for 2 years and then every 6 months thereafter.

      PROJECTED ACCRUAL: A total of 776 patients will be accrued for this study within 27 months.
    

Intervention name(s): carboplatin; paclitaxel; rebimastat
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Paclitaxel; Carboplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer