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| Sponsor: | Duke University |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00088959 |
Purpose
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: | January 2009 (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.
Eligibility| 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
Contacts and Locations| 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 |
More Information
| 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: | August 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00088959 History of Changes |
| 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 Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action 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 Erlotinib 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 |