Study of Tarceva and Targretin Oral Capsules in Patients With Advanced Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Ligand Pharmaceuticals
Genentech
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00125359
First received: July 29, 2005
Last updated: August 1, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Carcinoma, Non-small-cell Lung
Drug: erlotinib and bexarotene
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Clinical Study of Erlotinib (Tarceva) and Bexarotene (Targretin) Oral Capsules in Patients With Advanced Non-small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • 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. [ Time Frame: Beginning of enrollment to accrual of last subject/ data analysis ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To correlate early PET responses with objective radiographic responses. [ Time Frame: Enrollment of first subject to accrual of last subject. ] [ Designated as safety issue: No ]
  • To evaluate the progression-free survival and overall survival of patients with advanced NSCLC treated with bexarotene in combination with erlotinib. [ Time Frame: enrollment of first subject to analysis of data. ] [ Designated as safety issue: No ]
  • To prospectively evaluate EGFR mutation in tumor biopsies and correlate their presence with objective radiographic responses. [ Time Frame: enrollment of first subject to analysis of the data. ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: August 2005
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
All eligible patients will receive continuous daily oral erlotinib 150mg with daily bexarotene oral capsules 400mg.
Drug: erlotinib and bexarotene
Daily Erlotinib 150mg and daily bexarotene oral capsules 400mg.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Advanced NSCLC
  • Prior chemotherapy or radiotherapy is allowed.

Exclusion Criteria:

  • Hepatic or renal dysfunction
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125359

Locations
United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756
United States, New York
Mount Sinai School of Medicine
New York City, New York, United States, 10029
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Ligand Pharmaceuticals
Genentech
Investigators
Principal Investigator: Konstantin H Dragnev, MD Norris Cotton Cancer Center
  More Information

No publications provided

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00125359     History of Changes
Other Study ID Numbers: D-0440
Study First Received: July 29, 2005
Last Updated: August 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Dartmouth-Hitchcock Medical Center:
tarceva
targretin
non-small cell lung cancer
Carcinoma, non-small cell lung cancer
Non-small cell lung cancer
NSCLC

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Bexarotene
Erlotinib
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014