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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Department of Defense |
---|---|
Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00411632 |
Primary Objective:
Secondary Objectives:
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: Bexarotene Drug: Erlotinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Erlotinib (Tarceva) in Combination With Bexarotene (Targretin) in Chemorefractory Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) |
Estimated Enrollment: | 62 |
Study Start Date: | November 2006 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Bexarotene + Erlotinib
|
Drug: Bexarotene
400 mg/m^2 by mouth daily x 28 Days
Drug: Erlotinib
150 mg by mouth daily x 28 Days
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The patient has a significant medical history or unstable medical condition (unstable systemic disease: congestive heart failure (New York Heart Association Functional Classification class II or worse), recent myocardial infarction within 3 months, unstable angina, active infection (i.e.
currently treated with antibiotics), uncontrolled hypertension). Patients with controlled diabetes will be allowed. Patient must be able to undergo procedure for tissue acquisition.
Contact: Christine Alden, BSN | 713-792-0734 |
United States, Texas | |
U.T. M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Edward Kim, MD |
Principal Investigator: | Edward Kim, MD | U.T. M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Edward Kim, MD/Assistant Professor ) |
Study ID Numbers: | 2005-0826 |
Study First Received: | December 12, 2006 |
Last Updated: | December 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00411632 History of Changes |
Health Authority: | United States: Institutional Review Board |
Lung Cancer Non-Small Cell Lung Cancer NSCLC Erlotinib Tarceva |
Bexarotene Targretin OSI-774 Battle Program |
Anticarcinogenic Agents Erlotinib Thoracic Neoplasms Respiratory Tract Diseases Bexarotene Lung Neoplasms |
Lung Diseases Non-small Cell Lung Cancer Protein Kinase Inhibitors Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Anticarcinogenic Agents Thoracic Neoplasms Erlotinib Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Protein Kinase Inhibitors Protective Agents |
Pharmacologic Actions Carcinoma Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Bexarotene Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |