NCT00002969

S9714: Paclitaxel in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

Phase II Trial of Paclitaxel by 96-Hour Infusion in Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of chemotherapy with paclitaxel in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Detailed description

OBJECTIVES: I. Assess survival, progression-free survival and response rate of patients with bronchioloalveolar carcinoma receiving paclitaxel. II. Evaluate toxic effects of paclitaxel in 96 hour continuous infusion patients. OUTLINE: Patients receive 6 cycles of paclitaxel by IV continuous infusion over 96 hours. Before cycle 4, restaging is performed. If disease progression is witnessed, patients are removed from the study. If a stable, partial, or complete response is observed, patients receive the total of 6 cycles. Three weeks after the last cycle, final restaging is performed. Patients are followed every 3 months while on treatment and every 6 months thereafter, unless more frequent follow-up is clinically recommended. PROJECTED ACCRUAL: 50 patients will be enrolled. The accrual rate is estimated at 25 per year.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	paclitaxel

Timeline

• Start date: 1997-05-01
• Primary completion: 2004-01-01
• Completion: 2007-01-01
• First posted: 2004-08-24
• Last updated: 2012-07-24

Locations

85 sites across 1 country: United States