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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Efficacy of combining Celecoxib with Docetaxel
Blood levels of VEGF \& PGE2
Time frame: Weeks 1 , 2 and 3
Response rate of Celecoxib and Docetaxel
CT Chest/Abdomen
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.
Toxicity of Celecoxib and Docetaxel
Routine bloodwork
Time frame: Every week
Expression of cyclooxygenase-2 (COX-2) in tumors
Tissue sample from initial diagnosis, parrafin embedded tissue block
Time frame: Pre-study
Changes in plasma levels of prostaglandin E2 (PGE2) & vascular endthelial growth factor (VEGF)
Collecting blood plasma
Time frame: Pre-study; Weeks 1 , 2 and 3
Vascular changes induced in the tumor by celecoxib
Using DCE-MRI and PET scans to evaluate.
Time frame: Weeks 1, 3 & 6
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