Study of Tarceva and Targretin Oral Capsules in Patients With Advanced Lung Cancer
The purpose of this study is to learn about the effects of two new anticancer drugs, erlotinib (Tarceva) and bexarotene (Targretin), when treating patients with advanced lung cancer.
Erlotinib is approved by the Food and Drug Administration (FDA) for the treatment of non-small-cell lung cancer (NSCLC). Bexarotene is approved by the FDA for the treatment of cutaneous T-cell lymphoma. This combination of drugs is experimental.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Clinical Study of Erlotinib (Tarceva) and Bexarotene (Targretin) Oral Capsules in Patients With Advanced Non-small Cell Lung Cancer|
- To evaluate the objective radiographic response rates to daily oral bexarotene in combination with oral erlotinib to patients with advanced non-small cell lung cancer. [ Time Frame: Beginning of enrollment to accrual of last subject/ data analysis ] [ Designated as safety issue: No ]
- To correlate early PET responses with objective radiographic responses. [ Time Frame: Enrollment of first subject to accrual of last subject. ] [ Designated as safety issue: No ]
- To evaluate the progression-free survival and overall survival of patients with advanced NSCLC treated with bexarotene in combination with erlotinib. [ Time Frame: enrollment of first subject to analysis of data. ] [ Designated as safety issue: No ]
- To prospectively evaluate EGFR mutation in tumor biopsies and correlate their presence with objective radiographic responses. [ Time Frame: enrollment of first subject to analysis of the data. ] [ Designated as safety issue: No ]
|Study Start Date:||August 2005|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
All eligible patients will receive continuous daily oral erlotinib 150mg with daily bexarotene oral capsules 400mg.
Drug: erlotinib and bexarotene
Daily Erlotinib 150mg and daily bexarotene oral capsules 400mg.
This is a single institution open label phase II trial. Consecutive, eligible patients presenting with the diagnosis of advanced NSCLC are to be enrolled in this study. All eligible patients will receive continuous daily oral erlotinib 150 mg (Tarceva™) with daily bexarotene oral capsules 400 mg/m2 (Targretin®). The two agents will be taken at the same time. We anticipate the maximum accrual of 40 patients to this trial.
Patients will be evaluated by history, physical examination, and laboratory assessment every 4 weeks. Radiographic disease assessments by chest radiograph will be obtained every 4 weeks and computer tomography every 8 weeks or longer if clinically indicated. Whole body PET scan will be obtained at 10 days and 8 weeks. All radiographic studies will be sent to Medical Metrix Solutions (MMS) for an independent radiographic review of tumor response.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00125359
|United States, New Hampshire|
|Norris Cotton Cancer Center|
|Lebanon, New Hampshire, United States, 03756|
|United States, New York|
|Mount Sinai School of Medicine|
|New York City, New York, United States, 10029|
|Principal Investigator:||Konstantin H Dragnev, MD||Norris Cotton Cancer Center|