Paclitaxel in Treating Patients With Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00002972|
Recruitment Status : Completed
First Posted : April 17, 2003
Last Update Posted : July 2, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: paclitaxel||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study on TAXOL in Bronchioalveolar Carcinoma|
|Study Start Date :||January 1997|
|Actual Primary Completion Date :||August 2002|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002972
|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|