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| Sponsor: | Barbara Ann Karmanos Cancer Institute |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00068653 |
Purpose
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Celecoxib may slow the growth of cancer by stopping blood flow to the tumor. Combining gefitinib with celecoxib may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining gefitinib with celecoxib in treating patients who have non-small cell lung cancer that is refractory to platinum-based chemotherapy (such as cisplatin or carboplatin).
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: celecoxib Drug: gefitinib |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Phase II Study of the Combination of ZD1839 (Iressa) and Celecoxib in Patients With Platinum Refractory Non-Small Cell Lung Cance |
| Study Start Date: | June 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive oral gefitinib once daily and oral celecoxib twice daily on days 1-28. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed for up to 6 weeks.
PROJECTED ACCRUAL: A total of 18-27 patients will be accrued for this study within 22 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Progression of disease during platinum-based (cisplatin or carboplatin) chemotherapy or within 3 months of completing chemotherapy
Measurable disease
No active brain or leptomeningeal metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No other concurrent NSAIDs
No concurrent use of any of the following:
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | CDR0000327805, WSU-C-2563, ZENECA-1839US/0252 |
| Study First Received: | September 10, 2003 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00068653 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent non-small cell lung cancer |
|
Thoracic Neoplasms Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Protein Kinase Inhibitors Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Gefitinib Respiratory Tract Neoplasms |
Celecoxib Neoplasms by Histologic Type Cyclooxygenase Inhibitors Enzyme Inhibitors Pharmacologic Actions Carcinoma Neoplasms Analgesics, Non-Narcotic Lung Diseases Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |