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Sponsors and Collaborators: |
Duke University National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00088959 |
RATIONALE: Celecoxib and erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PURPOSE: This phase I trial is studying the side effects and best dose of celecoxib when given together with erlotinib in treating former smokers with stage IIIB, stage IV, recurrent, or progressive non-small cell lung cancer
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: celecoxib Drug: erlotinib hydrochloride |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase I Study of Erlotinib and Celecoxib in Former Smokers With Advanced Non-Small Cell Lung Cancer |
Estimated Enrollment: | 45 |
Study Start Date: | September 2004 |
Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, dose-escalation study of celecoxib.
Patients receive oral erlotinib hydrochloride once daily and oral celecoxib twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 6 patients receive escalating doses of celecoxib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, up to 6 additional patients are treated at the MTD.
Patients are followed at 4 weeks.
PROJECTED ACCRUAL: A total of 6-45 patients 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:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) meeting 1 of the following stage criteria:
Meets 1 of the following criteria:
Relapsed or refractory disease after treatment with ≥ 1 prior platinum-containing chemotherapy program, including adjuvant or neoadjuvant therapy for NSCLC
Former smoker, as indicated by the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent medication known to interact with erlotinib hydrochloride or celecoxib, including the following:
No concurrent non-steroidal anti-inflammatory drugs
Concurrent aspirin of up to an average dose of 325 mg/day allowed
United States, North Carolina | |
Duke Comprehensive Cancer Center | |
Durham, North Carolina, United States, 27710 | |
Veterans Affairs Medical Center - Durham | |
Durham, North Carolina, United States, 27705 |
Principal Investigator: | Michael J. Kelley, MD | Duke University |
Study ID Numbers: | CDR0000377689, DUMC-4939-04-6R2, DUMC-4939-03-6R0, VAMC-DURHAM-00813, DUMC-GCRC-911 |
Study First Received: | August 4, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00088959 |
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 |
Erlotinib Thoracic Neoplasms Non-small cell lung cancer Celecoxib Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Carcinoma, Non-Small-Cell Lung Recurrence Neoplasms, Glandular and Epithelial Carcinoma |
Anti-Inflammatory Agents Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions Neoplasms |
Neoplasms by Site Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |