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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA022453 | U.S. NIH Grant/Contract | View source | |
| WSU-C-2304 | Other Identifier | Barbara Ann Karmanos Cancer Institute | |
| NCI-V01-1688 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Celecoxib & Docetaxel | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib | Drug | 400mg by mouth, twice a day, each dose given with meals, to start -7 days prior to first cycle of treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of combining Celecoxib with Docetaxel | Blood levels of VEGF & PGE2 | Weeks 1 , 2 and 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate of Celecoxib and Docetaxel | CT Chest/Abdomen | 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 |
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DISEASE CHARACTERISTICS:
Diagnosis of stage IIIA, IIIB, or IV non-small cell lung cancer
Measurable or evaluable disease
No symptomatic or untreated brain or leptomeningeal metastases
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Gastrointestinal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Shirish M. Gadgeel, MD | Barbara Ann Karmanos Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201-1379 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19057272 | Result | Schneider BJ, Kalemkerian GP, Kraut MJ, Wozniak AJ, Worden FP, Smith DW, Chen W, Gadgeel SM. Phase II study of celecoxib and docetaxel in non-small cell lung cancer (NSCLC) patients with progression after platinum-based therapy. J Thorac Oncol. 2008 Dec;3(12):1454-9. doi: 10.1097/JTO.0b013e31818de1d2. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Docetaxel | Drug | On day 1, 75mg/m2 IV over 60 minutes, repeated every 21 days |
|
|
Routine bloodwork |
| Every week |
| Expression of cyclooxygenase-2 (COX-2) in tumors | Tissue sample from initial diagnosis, parrafin embedded tissue block | Pre-study |
| Changes in plasma levels of prostaglandin E2 (PGE2) & vascular endthelial growth factor (VEGF) | Collecting blood plasma | Pre-study; Weeks 1 , 2 and 3 |
| Vascular changes induced in the tumor by celecoxib | Using DCE-MRI and PET scans to evaluate. | Weeks 1, 3 & 6 |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |