NCT00030420

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

Evaluation Of Celecoxib In Combination With Docetaxel In The Treatment Of Advanced Non-Small Cell Lung Cancer Patients Previously Treated With Platinum Based Chemotherapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (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 with celecoxib may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining celecoxib and docetaxel in treating patients who have advanced non-small cell lung cancer that has been previously treated with platinum-based chemotherapy.

Detailed description

OBJECTIVES: * Determine the efficacy and feasibility of celecoxib combined with docetaxel in patients with advanced non-small cell lung cancer previously treated with platinum-based chemotherapy. * 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 day 1. Treatment repeats every 21 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	400mg by mouth, twice a day, each dose given with meals, to start -7 days prior to first cycle of treatment.
DRUG	Docetaxel	On day 1, 75mg/m2 IV over 60 minutes, repeated every 21 days

Timeline

• Start date: 2001-10-01
• Primary completion: 2004-05-01
• Completion: 2008-02-01
• First posted: 2003-10-21
• Last updated: 2013-04-29

Locations

1 site across 1 country: United States