Paclitaxel and Carboplatin With or Without Celecoxib Before Surgery in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00062179|
Recruitment Status : Completed
First Posted : June 6, 2003
Last Update Posted : October 2, 2015
RATIONALE: Drugs used in chemotherapy such as paclitaxel and carboplatin use different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug, may stop the growth of tumor cells by stopping blood flow to the tumor, and/or may block the enzymes necessary for tumor cell growth. Giving combination chemotherapy with celecoxib before surgery may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying how well giving paclitaxel together with carboplatin followed by surgery works compared to giving paclitaxel together with carboplatin and celecoxib followed by surgery in treating patients with stage IIIA non-small cell lung cancer.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: carboplatin Drug: celecoxib Drug: paclitaxel Other: Placebo||Phase 2|
- Compare the complete pathological response rate and/or minimal residual microscopic disease in patients with stage IIIA non-small cell lung cancer treated with preoperative paclitaxel and carboplatin with vs without celecoxib.
- Compare the clinical response rate in patients treated with these regimens.
- Compare chemotherapy-related toxicity in patients treated with these regimens.
- Compare the time to progression, disease-free survival, and overall survival of patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to use of aspirin for prior cardiovascular disease (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on days 1, 22, and 43. Patients also receive oral celecoxib twice daily beginning on day 1 and continuing until the morning of surgical resection.
- Arm II: Patients receive paclitaxel and carboplatin as in arm I and an oral placebo twice daily beginning on day 1 and continuing until the morning of surgical resection.
In both arms, patients undergo surgical resection and complete mediastinal lymph node dissection within 3-6 weeks after completion of chemotherapy. Patients resume oral celecoxib or placebo twice daily within 28-42 days after surgery and continue until 3 years from the date of randomization in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3-6 months.
PROJECTED ACCRUAL: A total of 110 patients (55 per treatment arm) will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized Double Blind Phase II Study of Preoperative Celecoxib/Paclitaxel/Carboplatin for Stage IIIA Non-Small Cell Lung Cancer|
|Study Start Date :||March 2003|
|Primary Completion Date :||November 2006|
|Study Completion Date :||November 2006|
Paclitaxel: 225 mg/m2 by 3-hour intravenous infusion Carboplatin: dosed at an AUC of 6 by the Calvert Formula Celecoxib: 400 mg po BID 3 cycles of paclitaxel and carboplatin 21 days apart celecoxib 3-7 days before first dose of chemotherapy
Carboplatin: dosed at an AUC of 6 by the Calvert Formula 3 cycles of carboplatin 21 days apartDrug: celecoxib
Celecoxib: 400 mg po BID celecoxib 3-7 days before first dose of chemotherapyDrug: paclitaxel
Paclitaxel: 225 mg/m2 by 3-hour intravenous infusion 3 cycles of paclitaxel 21 days apart
Placebo Comparator: paclitaxel/Carboplatin/Placebo
Paclitaxel: 225 mg/m2 by 3-hour intravenous infusion Carboplatin: dosed at an AUC of 6 by the Calvert Formula Placebo 3 cycles of paclitaxel and carboplatin 21 days apart Placebo 3-7 days before first dose of chemotherapy
Carboplatin: dosed at an AUC of 6 by the Calvert Formula 3 cycles of carboplatin 21 days apartDrug: paclitaxel
Paclitaxel: 225 mg/m2 by 3-hour intravenous infusion 3 cycles of paclitaxel 21 days apartOther: Placebo
placebo 3-7 days before first dose of chemotherapy
- Rates of complete pathological response and/or minimal residual microscopic disease at 3 years [ Time Frame: 3 years ]
- Clinical response at 3 years [ Time Frame: 3 years ]
- Difference in time to progression, disease-free survival, and overall survival between Arm I and Arm II at 3 years [ Time Frame: 3 years ]
- Toxicity in patients with paclitaxel/carboplatin/celecoxib vs. paclitaxel/carboplatin/placebo
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): NCT00062179
|United States, California|
|Jonsson Comprehensive Cancer Center at UCLA|
|Los Angeles, California, United States, 90095-1781|
|United States, New York|
|New York Weill Cornell Cancer Center at Cornell University|
|New York, New York, United States, 10021|
|Principal Investigator:||Karen Rickard||City of Hope Comprehensive Cancer Center|