A Phase II Clinical Study of Erlotinib (Tarceva) and Bexarotene (Targretin) Oral Capsules in Patients With Advanced Non-small Cell Lung Cancer
Overview
- Phase
- Phase 2
- Intervention
- erlotinib and bexarotene
- Conditions
- Carcinoma, Non-small-cell Lung
- Sponsor
- Konstantin Dragnev
- Enrollment
- 42
- Locations
- 2
- Primary Endpoint
- Radiographic Response Rates
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Konstantin Dragnev
Associate Professor of Medicine
Dartmouth-Hitchcock Medical Center
Eligibility Criteria
Inclusion Criteria
- •Advanced NSCLC
- •Prior chemotherapy or radiotherapy is allowed.
Exclusion Criteria
- •Hepatic or renal dysfunction
Arms & Interventions
1
All eligible patients will receive continuous daily oral erlotinib 150mg with daily bexarotene oral capsules 400mg.
Intervention: erlotinib and bexarotene
Outcomes
Primary Outcomes
Radiographic Response Rates
Time Frame: Through study completion, an average of 1 year
Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Secondary Outcomes
- Correlation of Early PET Responses With Objective Radiographic Responses.(Through study completion, an average of 1 year)
- Progression-free Survival and Overall Survival(Through study completion, an average of 1 year)
- Evaluation of EGFR Mutations in Tumor Biopsies and Correlation of EGFR Mutations With Objective Radiographic Responses.(Through study completion, an average of 1 year)