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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA022453 | U.S. NIH Grant/Contract | View source | |
| WSU-C-2305 | Other Identifier | Barbara Ann Karmanos Cancer Institute | |
| NCI-V01-1687 |
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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 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.
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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Celecoxib & Docetaxel | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib | Drug | On day -7 of the first cycle, patients will start, Celecoxib 400 mg po bid daily, each dose to give with meals |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of combining celecoxib with docetaxel in elderly (> or = 70 yrs old) or poor performance status (PS)of 2 | 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 Celecosxib, 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 non-small cell lung cancer (NSCLC)
Age 70 years and over with SWOG performance status 0-2 OR age 18 to 69 with SWOG performance status 2
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 |
|---|---|---|---|
| 18978565 | Result | Gadgeel SM, Wozniak A, Ruckdeschel JC, Heilbrun LK, Venkatramanamoorthy R, Chaplen RA, Kraut MJ, Kalemkerian GP. Phase II study of docetaxel and celecoxib, a cyclooxygenase-2 inhibitor, in elderly or poor performance status (PS2) patients with advanced non-small cell lung cancer. J Thorac Oncol. 2008 Nov;3(11):1293-300. doi: 10.1097/JTO.0b013e31818b194e. | |
| Result | Gadgeel SM, Shehadeh N, Kraut MJ, et al.: Preliminary results of a phase II study of celecoxib and weekly docetaxel in elderly (>70 yrs) or PS2 patients with advanced non-small cell lung cancer (NSCLC). [Abstract] Lung Cancer 41 (Suppl 2): A-O-110, S35, 2003. |
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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, 8, and 15 of each cycle patients will receive: Docetaxel 36mg/m2 over 60 minutes, duration of each cycle will be 28 days. |
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|
Routine bloodwork |
| Weeks 1, 2, and 3 of each 28 day cycle |
| 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 endothelial growth factor (VEGF) | Collecting blood plasma | Pre-study, Weeks 1, 2 and 5 |
| 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 |