Study of Tarceva and Targretin Oral Capsules in Patients With Advanced Lung Cancer
| Status: | Completed |
|---|---|
| Conditions: | Lung Cancer, Lung Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/10/2019 |
| Start Date: | August 2005 |
| End Date: | March 2014 |
A Phase II Clinical Study of Erlotinib (Tarceva) and Bexarotene (Targretin) Oral Capsules in Patients With Advanced Non-small Cell 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.
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.
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.
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.
Inclusion Criteria:
- Advanced NSCLC
- Prior chemotherapy or radiotherapy is allowed.
Exclusion Criteria:
- Hepatic or renal dysfunction
We found this trial at
2
sites
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