A Phase I Clinical Study of Erlotinib (Tarceva) and Bexarotene (Targretin) Oral Capsules in Advanced Cancers of the Aerodigestive Tract
This is a single institution open label dose-ranging trial. Consecutive, eligible patients
presenting with the diagnosis of advanced aerodigestive tract malignancy are to be enrolled
in this study. All eligible patients will receive continuous daily oral erlotinib (Tarceva™)
with daily bexarotene oral capsules (Targretin®). The two agents will be taken at the same
time. Three dose levels of daily bexarotene in combination with daily erlotinib will be
studied.
Eligible patients will be entered in cohorts of three at each dose level. Doses will not be
escalated over the course of treatment of an individual patient. If a single patient
experiences grade 4 hematologic or ≥ grade 3 non-hematologic toxicity (excluding
hyperlipidemia and nausea/vomiting), the next group of three patients will be entered at the
same dose. A maximum of 6 evaluable patients will be enrolled at any one dose level. Dose
escalation is performed after all patients (3 or 6) at the previous dose level have received
treatment for 4 weeks. Treatment will continue until progression of disease, unacceptable
adverse effects, or patient refusal. If grade 4 hematologic or ≥ grade 3 non-hematologic
toxicity (excluding hyperlipidemia and nausea/vomiting) is observed in two or more patients
on dose level 1, the next three patients (or six if similar toxicity develops in one of the
first three patients) will receive dose level -1. If such toxicity is seen in two or more
patients, the trial will be terminated. We anticipate the maximum accrual of 18 patients to
this trial.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase II dose determination and evaulation of the safety of administering bexarotene(Targretin®) daily in combination with oral erlotinib (Tarceva™) to patients with advanced aerodigestive tract cancers.
The purpose of this study is to evaluate the safety of daily oral administration of bexarotene in combination with erlotinib at three dose levels to patients with advanced aerodigestive tract cancer. At least 3 patients will be entered onto each dose level. Dose limiting toxicity is defined as grade 3 or greater non-hematologic toxicity or grade 4 hematologic toxicity. The recommended Phase II dose is defined as the highest dose level of bexarotene oral capsules in combination with oral erlotinib that induces DLT in fewer than 33% of patients.
When final patient is removed from study or at the discreation of the investigator
No
Konstantin H. Dragnev, MD
Principal Investigator
Dartmouth-Hitchcock Medical Center
United States: Food and Drug Administration
D0228
NCT01116622
April 2003
January 2013
Name | Location |
---|---|
Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756 |