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Sponsors and Collaborators: |
Robert H. Lurie Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00073866 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor. Combining celecoxib with combination chemotherapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of irinotecan and docetaxel when given together with celecoxib and to see how well they work in treating patients with advanced non-small cell lung cancer.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: celecoxib Drug: docetaxel Drug: irinotecan hydrochloride |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I/II Trial Of Weekly Irinotecan And Docetaxel With The Addition Of Celecoxib In Advanced Non-Small Cell Lung Cancer |
Study Start Date: | June 2003 |
Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of docetaxel and irinotecan.
Patients are followed every 3 months until disease progression.
PROJECTED ACCRUAL: A total of 3-70 patients (3-36 for phase I and 16-34 for phase II) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of non-small cell lung cancer (NSCLC) meeting 1 of the following criteria:
Unidimensionally measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Phase I patients:
Phase II patients:
Chemotherapy
Phase I patients:
Phase II patients:
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Illinois | |
Evanston Northwestern Health Care - Evanston Hospital | |
Evanston, Illinois, United States, 60201 | |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
Chicago, Illinois, United States, 60611-3013 | |
Silver Cross Hospital | |
Joliet, Illinois, United States, 60432 |
Study Chair: | Athanassios Argiris, MD | Robert H. Lurie Cancer Center |
Study ID Numbers: | CDR0000285672, NU-01L2, PHARMACIA-NU-01L2 |
Study First Received: | December 10, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00073866 |
Health Authority: | United States: Federal Government |
recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
Thoracic Neoplasms Non-small cell lung cancer Celecoxib Irinotecan Recurrence Camptothecin Carcinoma |
Docetaxel Respiratory Tract Diseases Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Anti-Inflammatory Agents Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Pharmacologic Actions Neoplasms |
Neoplasms by Site Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents Antineoplastic Agents, Phytogenic |