NCT00062179

Paclitaxel and Carboplatin With or Without Celecoxib Before Surgery in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer

A Randomized Double Blind Phase II Study of Preoperative Celecoxib/Paclitaxel/Carboplatin for Stage IIIA Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * 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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	carboplatin	Carboplatin: dosed at an AUC of 6 by the Calvert Formula 3 cycles of carboplatin 21 days apart
DRUG	celecoxib	Celecoxib: 400 mg po BID celecoxib 3-7 days before first dose of chemotherapy
DRUG	paclitaxel	Paclitaxel: 225 mg/m2 by 3-hour intravenous infusion 3 cycles of paclitaxel 21 days apart
OTHER	Placebo	placebo 3-7 days before first dose of chemotherapy

Timeline

• Start date: 2003-03-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2003-06-06
• Last updated: 2020-08-03

Locations

2 sites across 1 country: United States