Paclitaxel in Treating Patients With Lung Cancer
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.
|Study Design:||Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study on TAXOL in Bronchioalveolar Carcinoma|
|Study Start Date:||January 1997|
|Primary Completion Date:||August 2002 (Final data collection date for primary outcome measure)|
- 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.
|Centre Hospitalier Regional de la Citadelle|
|Liege (Luik), Belgium, 4000|
|University Thomayers' Hospital|
|Krhanice, Czech Republic, 257 42|
|Universitaetsklinik und Strahlenklinik - Essen|
|Essen, Germany, D-45122|
|Azienda Ospedale S. Luigi - Universita Di Torino|
|Orbassano, (Torino), Italy, 10043|
|Vrije Universiteit Medisch Centrum|
|Amsterdam, Netherlands, 1001HV|
|Study Chair:||Giorgio Scagliotti, MD, PhD||Azienda Ospedale S. Luigi at University of Torino|