NCT00362882

Docetaxel and Bortezomib in Treating Patients With Progressive or Recurrent Non-Small Cell Lung Cancer

Randomized Phase II Trial of Sequential Versus Concurrent Docetaxel and PS-341 (NSC 681239) in Previously Treated Non-Small Cell Lung Cancer (NSCLC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-small Cell Lung Cancer
• Recurrent Non-small Cell Lung Cancer
• Stage IV Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	docetaxel	Given IV
DRUG	bortezomib	Given IV
OTHER	laboratory biomarker analysis	correlative study
OTHER	immunoenzyme technique	correlative study
OTHER	immunohistochemistry staining method	correlative study
OTHER	pharmacological study	correlative study

Timeline

• Start date: 2006-07-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2006-08-15
• Last updated: 2017-12-05
• Results posted: 2014-10-02

Locations

1 site across 1 country: United States