Study of Tarceva and Targretin Oral Capsules in Patients With Advanced Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00125359|
Recruitment Status : Completed
First Posted : August 1, 2005
Last Update Posted : November 13, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-small-cell Lung||Drug: erlotinib and bexarotene||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Clinical Study of Erlotinib (Tarceva) and Bexarotene (Targretin) Oral Capsules in Patients With Advanced Non-small Cell Lung Cancer|
|Study Start Date :||August 2005|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
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.
- 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 ]
- To correlate early PET responses with objective radiographic responses. [ Time Frame: Enrollment of first subject to accrual of last subject. ]
- 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. ]
- 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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|