Clinical Trial: Paclitaxel in Treating Patients With Lung Cancer
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase II Study on TAXOL in Bronchioalveolar Carcinoma
Brief 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 Summary:
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.
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: European Organisation for Research and Treatment of Cancer - EORTC
Dates:
Date Received: November 1, 1999
Date Started: January 1997
Date Completion:
Last Updated: June 29, 2012
Last Verified: June 2012
