Erlotinib (Tarceva) and Bexarotene (Targretin) Oral Capsules in Advanced Cancers of the Aerodigestive Tract

Conditions

• Advanced, Malignant Aerodigestive Tract Tumor (Lung, Head and Neck and Esophagus)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bexarotene (Targretin®) — DRUG
  Level -I 200 mg/m2 Level I 300 mg/m2 Level II 300 mg/m2 Level III 400 mg/m2
• Erlotinib (Tarceva™) — DRUG
  Level -1 100mg Level I 100mg Level II 150mg Level III 150mg

Study Details

Primary objective: To determine the Phase II doses and to evaluate the safety of administering bexarotene (Targretin®) daily in combination with oral erlotinib (Tarceva™) to patients with advanced aerodigestive tract cancers. Secondary objectives: To evaluate the response rates, progression-free survival and overall survival of patients with advanced aerodigestive tract cancers treated with bexarotene (Targretin®) in combination with erlotinib (Tarceva™). To investigate the activity of this targeted combination therapy by evaluating changes in molecular markers from pre- and post-treatment buccal swab samples.

Key Dates

First listed

May 5, 2010

Start date

Apr 30, 2003

Status verified

Nov 2014

Primary completion

Apr 30, 2014

Completion

Apr 30, 2014

Study Design

Enrollment

24 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Daily oral erlotinib and bexarotene capusles
  Open label dose-ranging trial

Primary Outcome Measure

Phase II dose determination and evaluation of the safety of administering bexarotene(Targretin®) daily in combination with oral erlotinib (Tarceva™) to patients with advanced aerodigestive tract cancers. [ Time Frame: When final patient is removed from study or at the discreation of the investigator ]

Locations (1)

Find similar trials in Lebanon, NH