Clinical trial NCT00125359: Study of Tarceva and Targretin Oral Capsules in Patients With Advanced Lung Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-small-cell Lung
Keywords: tarceva
targretin
non-small cell lung cancer
Carcinoma, non-small cell lung cancer
NSCLC
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Ligand Pharmaceuticals
name: Genentech, Inc.
First posted: 2005-08-01
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Advanced NSCLC
* Prior chemotherapy or radiotherapy is allowed.

Exclusion Criteria:

* Hepatic or renal dysfunction

Primary outcomes:
measure: Radiographic Response Rates
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Correlation of Early PET Responses With Objective Radiographic Responses.
timeFrame: Through study completion, an average of 1 year
measure: Progression-free Survival and Overall Survival
timeFrame: Through study completion, an average of 1 year
measure: Evaluation of EGFR Mutations in Tumor Biopsies and Correlation of EGFR Mutations With Objective Radiographic Responses.
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Norris Cotton Cancer Center
state: New Hampshire
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
Study officials:
affiliation: Norris Cotton Cancer Center
name: Konstantin H Dragnev, MD
role: PRINCIPAL_INVESTIGATOR
References: