Celecoxib and Docetaxel in Treating Patients With Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00030407|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 29, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: Celecoxib Drug: Docetaxel||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation Of Celecoxib In Combination With Weekly Docetaxel In Elderly (70 Years) Or Poor Performance Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)|
|Study Start Date :||October 2001|
|Actual Primary Completion Date :||September 2005|
|Actual Study Completion Date :||April 2009|
Experimental: Celecoxib & Docetaxel
Celecoxib: On day -7 of the first cycle, patients will start, Celecoxib 400 mg po bid daily, each dose to give with meals
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.
On day -7 of the first cycle, patients will start, Celecoxib 400 mg po bid daily, each dose to give with meals
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.
Other Name: Taxotere®
- Efficacy of combining celecoxib with docetaxel in elderly (> or = 70 yrs old) or poor performance status (PS)of 2 [ Time Frame: Weeks 1, 2, and 3 ]Blood levels of VEGF & PGE2
- Response rate of Celecoxib and Docetaxel [ Time Frame: Every 2 cycles (or every 42 days); After therapy is completed or if the patient is only on Celecosxib, will be assessed for progression every month by clinical exam and every 3 months by radiological evaluation. ]CT Chest/Abdomen
- Toxicity of Celecoxib and Docetaxel [ Time Frame: Weeks 1, 2, and 3 of each 28 day cycle ]Routine bloodwork
- Expression of cyclooxygenase-2 (COX-2) in tumors [ Time Frame: Pre-Study ]Tissue sample from initial diagnosis, parrafin embedded tissue block
- Changes in plasma levels of prostaglandin E2(PGE2) & vascular endothelial growth factor (VEGF) [ Time Frame: Pre-study, Weeks 1, 2 and 5 ]Collecting blood plasma
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): NCT00030407
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|Study Chair:||Shirish M. Gadgeel, MD||Barbara Ann Karmanos Cancer Institute|