Docetaxel and Bortezomib in Treating Patients With Progressive or Recurrent Non-Small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer; Recurrent Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is studying two different schedules of docetaxel and bortezomib to compare how
      well they work in treating patients with progressive or recurrent non-small cell lung cancer.
      Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of
      tumor cells, either by killing the cells or by stopping them from dividing. Bortezomib may
      stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving
      docetaxel together with bortezomib may kill more tumor cells
    

Detailed description: 
      PRIMARY OBJECTIVE:

      I. To compare the efficacy and tolerability of sequential vs concurrent docetaxel and
      bortezomib in patients with previously treated, progressive or recurrent, advanced non-small
      cell lung cancer (NSCLC).

      SECOND OBJECTIVES:

      I. To compare time to progression in patients with previously treated NSCLC treated with
      these regimens.

      II. To compare 1-year and overall survival of patients treated with these regimens.

      III. To compare the toxicity of these regimens in these patients. IV. To determine the
      pharmacokinetics of docetaxel in the context of this study.

      TERTIARY OBJECTIVE:

      I. To determine levels of expression of molecular markers regulated by docetaxel and
      bortezomib and correlate with clinical response and overall survival of these patients.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG
      performance status (0 vs 1) and number of prior chemotherapy treatments (1 vs >1). Patients
      are randomized to 1 of 2 treatment arms.

      ARM I: Patients receive docetaxel IV over 60 minutes on day 1 and bortezomib IV over 3-5
      seconds on days 1 and 8. Treatment repeats every 21 days for up to 8 courses in the absence
      of disease progression or unacceptable toxicity.

      ARM II: Patients receive docetaxel as in arm I and bortezomib IV over 3-5 seconds on days 2
      and 8. Treatment repeats every 21 days for up to 8 courses in the absence of disease
      progression or unacceptable toxicity.

      After completion of study therapy, patients are followed periodically.
    

Intervention name(s): docetaxel; bortezomib; laboratory biomarker analysis; immunoenzyme technique; immunohistochemistry staining method; pharmacological study
Intervention type(s): Drug; Drug; Other; Other; Other; Other
Intervention description(s): Given IV; Given IV; correlative study; correlative study; correlative study; correlative study
Other intervention name(s): RP 56976; Taxotere; TXT; LDP 341; MLN341; VELCADE; immunoenzyme techniques; immunohistochemistry; pharmacological studies
Intervention MeSH terms: Docetaxel; Bortezomib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment