Celecoxib and Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer
- Registration Number
- NCT00030420
- Lead Sponsor
- Barbara Ann Karmanos Cancer Institute
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Celecoxib & Docetaxel Celecoxib 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 Celecoxib & Docetaxel 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
- Primary Outcome Measures
Name Time Method Efficacy of combining Celecoxib with Docetaxel Weeks 1 , 2 and 3 Blood levels of VEGF \& PGE2
- Secondary Outcome Measures
Name Time Method Response rate of Celecoxib and Docetaxel 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 Every week Routine bloodwork
Expression of cyclooxygenase-2 (COX-2) in tumors Pre-study Tissue sample from initial diagnosis, parrafin embedded tissue block
Changes in plasma levels of prostaglandin E2 (PGE2) & vascular endthelial growth factor (VEGF) Pre-study; Weeks 1 , 2 and 3 Collecting blood plasma
Vascular changes induced in the tumor by celecoxib Weeks 1, 3 & 6 Using DCE-MRI and PET scans to evaluate.
Trial Locations
- Locations (1)
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States