NCT00052338

Bortezomib Plus Gemcitabine and Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer

A Phase I Study Of PS-341 In Combination With Gemcitabine And Carbloplatin In Selected Stage IIIB Or IV Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug and bortezomib may kill more tumor cells

Detailed description

PRIMARY OBJECTIVES: I. Determine the safety and feasibility of combining bortezomib with gemcitabine and carboplatin in patients with advanced or recurrent non-small cell lung cancer. II. Determine the maximum tolerated dose of bortezomib administered in combination with gemcitabine and carboplatin in these patients. III. Correlate results from laboratory studies on patient tissue and serum specimens with potential predictors of response in patients treated with this regimen. IV. Determine, preliminarily, the response of patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of bortezomib. Patients receive gemcitabine IV over 30 minutes on days 1 and 8, carboplatin IV over 15-30 minutes on day 1, followed 1 hour later by bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with a clinical or radiographic response may continue receiving bortezomib beyond 6 courses. Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, at least 10 additional patients with chemotherapy-naive disease receive treatment as above with the MTD of bortezomib. Patients are followed for survival.

Conditions

• Malignant Pleural Effusion
• Recurrent Non-small Cell Lung Cancer
• Stage IIIB Non-small Cell Lung Cancer
• Stage IV Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	gemcitabine hydrochloride	Given IV
DRUG	carboplatin	Given IV
DRUG	bortezomib	Given IV
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2002-09-01
• Primary completion: 2004-05-01
• First posted: 2003-01-27
• Last updated: 2013-01-23

Locations

1 site across 1 country: United States