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A Phase II Clinical Study of Erlotinib (Tarceva) and Bexarotene (Targretin) Oral Capsules in Patients With Advanced Non-small Cell Lung Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Non-small-cell Lung

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Trial Information

A Phase II Clinical Study of Erlotinib (Tarceva) and Bexarotene (Targretin) Oral Capsules in Patients With Advanced Non-small Cell Lung Cancer


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.


Inclusion Criteria:



- Advanced NSCLC

- Prior chemotherapy or radiotherapy is allowed.

Exclusion Criteria:

- Hepatic or renal dysfunction

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the objective radiographic response rates to daily oral bexarotene in combination with oral erlotinib to patients with advanced non-small cell lung cancer.

Outcome Time Frame:

Beginning of enrollment to accrual of last subject/ data analysis

Safety Issue:

No

Principal Investigator

Konstantin H Dragnev, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Norris Cotton Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

D-0440

NCT ID:

NCT00125359

Start Date:

August 2005

Completion Date:

July 2013

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • tarceva
  • targretin
  • non-small cell lung cancer
  • Carcinoma, non-small cell lung cancer
  • Non-small cell lung cancer
  • NSCLC
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location
Mount Sinai School of Medicine New York, New York  10029
Norris Cotton Cancer Center Lebanon, New Hampshire  03756