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Completed

NCT Number: NCT00125359

Study of Tarceva and Targretin Oral Capsules in Patients With Advanced 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.

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Norris Cotton Cancer Center, Lebanon, New Hampshire, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Advanced NSCLC
  • Prior chemotherapy or radiotherapy is allowed.

Exclusion criteria

  • Hepatic or renal dysfunction

Treatment and study plan

erlotinib and bexarotene

Drug

Daily Erlotinib 150mg and daily bexarotene oral capsules 400mg.

Primary outcomes

  1. Radiographic Response Rates

    Time frame: Through study completion, an average of 1 year

    Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Secondary outcomes

  1. Correlation of Early PET Responses With Objective Radiographic Responses.

    Time frame: Through study completion, an average of 1 year

    PET response is assessed based on the guidelines of the European Organization for Research and Treatment of Cancer (EORTC) PET Study Group (Eur J Cancer 1999; 35(13):1773-82). PET response refers to the presence and measurement of the most current PET scan imaging when compared to baseline imaging. The amount of reduction in the disease from baseline to current imaging determines the extent to which the cancer has responded to treatment. Radiographic response is per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

  2. Progression-free Survival and Overall Survival

    Time frame: Through study completion, an average of 1 year

  3. Evaluation of EGFR Mutations in Tumor Biopsies and Correlation of EGFR Mutations With Objective Radiographic Responses.

    Time frame: Through study completion, an average of 1 year

Sponsors and collaborators

Lead sponsor

Konstantin Dragnev

Other

Collaborators

  • Genentech, Inc.
  • Ligand Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2014
Study completion
2014
First posted
Aug 1, 2005
Registry last updated
Jan 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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