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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Department of Defense |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00411632 |
Purpose
Primary Objective:
The primary objective is to determine the 8 week progression-free survival rate (i.e. disease control rate) in patients with advanced Non-Small Cell Lung Cancer (NSCLC) who have failed at least one prior chemotherapy regimen.
Secondary Objectives:
The secondary objectives of this study will be to:
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: Bexarotene Drug: Erlotinib |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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: | 72 |
| Study Start Date: | November 2006 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Bexarotene + Erlotinib |
Drug: Bexarotene
400 mg/m^2 by mouth daily x 28 Days
Other Name: Targretin
Drug: Erlotinib
150 mg by mouth daily x 28 Days
Other Names:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Edward Kim, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00411632 History of Changes |
| Other Study ID Numbers: | 2005-0826 |
| Study First Received: | December 12, 2006 |
| Last Updated: | October 21, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Lung Cancer Non-Small Cell Lung Cancer NSCLC Erlotinib Tarceva |
Bexarotene Targretin OSI-774 Battle Program |
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Bexarotene |
Erlotinib Anticarcinogenic Agents Protective Agents Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |