NCT00002972

Paclitaxel in Treating Patients With Lung Cancer

Phase II Study on TAXOL in Bronchioalveolar Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years – 75 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 paclitaxel in treating patients who have unresectable stage IIIB, stage IV or recurrent lung cancer.

Detailed description

OBJECTIVES: * Assess the therapeutic activity of paclitaxel in patients with bronchoalveolar carcinoma (BAC). * Assess the duration of response in patients presenting with an objective response. * Characterize the acute side effects of paclitaxel in patients with BAC. * Assess the role of some biological parameters in the natural history and the response to therapy of BAC; evaluate the expression of Ki67, p53, and K-ras mutation. OUTLINE: This is an open label, nonrandomized, multicenter study. Paclitaxel is administered every 3 weeks as a 3 hour continuous infusion in dextrose or normal saline. Patients are treated for a minimum of 2 cycles unless serious toxicity or complication occur. Disease is assessed every 6 weeks until documented progression; treatment side effects are assessed separately for each cycle of therapy. Treatment is given up to a maximum of 6 cycles of therapy or until disease progression, unacceptable toxicity, or patient refusal occurs. PROJECTED ACCRUAL: 16 or 25 patients will be accrued.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	paclitaxel

Timeline

• Start date: 1997-01-01
• Primary completion: 2002-08-01
• First posted: 2003-04-17
• Last updated: 2012-07-02

Locations

5 sites across 5 countries: Belgium, Czechia, Germany, Italy, Netherlands