Celecoxib and Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00030420|
Recruitment Status : Completed
First Posted : October 21, 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 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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: Celecoxib Drug: Docetaxel||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation Of Celecoxib In Combination With Docetaxel In The Treatment Of Advanced Non-Small Cell Lung Cancer Patients Previously Treated With Platinum Based Chemotherapy|
|Study Start Date :||October 2001|
|Actual Primary Completion Date :||May 2004|
|Actual Study Completion Date :||February 2008|
Experimental: Celecoxib & Docetaxel
Celecoxib: 400mg by mouth, twice a day, each dose given with meals, to start -7 days prior to first cycle of treatment.
Doctaxel: Day 1, 75mg/m2 IV over 60 minutes, repeated every 21 days
400mg by mouth, twice a day, each dose given with meals, to start -7 days prior to first cycle of treatment.
On day 1, 75mg/m2 IV over 60 minutes, repeated every 21 days
Other Name: Taxotere
- Efficacy of combining Celecoxib with Docetaxel [ 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 Celecoxib, 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: Every week ]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 endthelial growth factor (VEGF) [ Time Frame: Pre-study; Weeks 1 , 2 and 3 ]Collecting blood plasma
- Vascular changes induced in the tumor by celecoxib [ Time Frame: Weeks 1, 3 & 6 ]Using DCE-MRI and PET scans to evaluate.
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): NCT00030420
|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|