NCT00030407

Celecoxib and Docetaxel in Treating Patients With Non-Small Cell Lung Cancer

Evaluation Of Celecoxib In Combination With Weekly Docetaxel In Elderly (70 Years) Or Poor Performance Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Celecoxib may slow the growth of cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy and celecoxib may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of celecoxib and docetaxel in treating patients who have non-small cell lung cancer.

Detailed description

OBJECTIVES: * Determine the efficacy and feasibility of celecoxib combined with docetaxel as first-line therapy in elderly or poor performance status patients with advanced non-small cell lung cancer. * Determine the response rate of patients treated with this regimen. * Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive oral celecoxib twice daily (beginning on day -7 of the first course) and docetaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 2 additional courses after CR. Patients who achieve stable disease (SD) or a partial response (PR) receive a minimum of 2 additional courses after SD or PR. At the discretion of the treating physician, patients then receive maintenance therapy comprising celecoxib only. Patients who discontinue therapy for disease progression or unacceptable toxicity are followed for at least 6 months. PROJECTED ACCRUAL: A total of 21-39 patients will be accrued for this study within 13-28 months.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Celecoxib	On day -7 of the first cycle, patients will start, Celecoxib 400 mg po bid daily, each dose to give with meals
DRUG	Docetaxel	On day 1, 8, and 15 of each cycle patients will receive: Docetaxel 36mg/m2 over 60 minutes, duration of each cycle will be 28 days.

Timeline

• Start date: 2001-10-01
• Primary completion: 2005-09-01
• Completion: 2009-04-01
• First posted: 2003-01-27
• Last updated: 2013-04-29

Locations

1 site across 1 country: United States