Study of Tarceva and Targretin in Stage I-II Lung Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborators:
Ligand Pharmaceuticals
Genentech
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00125372
First received: July 29, 2005
Last updated: January 8, 2013
Last verified: January 2013
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Purpose
The purpose of this study is to learn the effects on lung cancer of 2 new drugs, Tarceva and Targretin, given in combination before surgical removal of the tumor. Tarceva is approved by the Food and Drug Administration (FDA) for lung cancer. Targretin is approved for the treatment of cutaneous T-cell lymphoma. This combination of drugs is experimental.
| Condition | Intervention |
|---|---|
|
Carcinoma, Non-small-cell Lung |
Drug: erlotinib (Tarceva) and bexarotene (Targretin) |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Clinical and Pharmacologic Study of the Combination of Erlotinib and Bexarotene in Resectable Clinical Stage I-II Non-Small Cell Lung Cancer |
Resource links provided by NLM:
Further study details as provided by Dartmouth-Hitchcock Medical Center:
Primary Outcome Measures:
- pre and post study analysis of cyclin D1, epidermal growth factor receptor (EGFR), phospho-EGFR, and Ki-67 [ Time Frame: Analyses to be performed after accrual goal has been met ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- tumor tissue concentrations of erlotinib and bexarotene and correlation with plasma levels [ Time Frame: Analyses to be performed after accrual goal has been met ] [ Designated as safety issue: No ]
- mutational analysis of EGFR and its correlation with response [ Time Frame: Analyses to be performed after accrual goal has been met ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 12 |
| Study Start Date: | December 2005 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Erlotinib and Bexarotene
Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy.
|
Drug: erlotinib (Tarceva) and bexarotene (Targretin)
Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy
Other Names:
|
Detailed Description:
Erlotinib 150mg and bexarotene 400mg/m2 will be administered orally for 7-9 days prior to thoracotomy. Plasma samples will be collected on the day before surgery and along with tissue samples on the day of the thoracotomy. Analyses will be done on the resected specimen and it will be compared to the pre-study diagnostic specimen.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Resectable stage I or II non-small-cell lung cancer
- Prior tissue biopsy (not cytology) available for research analysis
- Adequate hepatic and renal function
Exclusion Criteria:
- Prior chemotherapy or radiotherapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00125372
Locations
| United States, New Hampshire | |
| Norris Cotton Cancer Center | |
| Lebanon, New Hampshire, United States, 03756 | |
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: | NCT00125372 History of Changes |
| Other Study ID Numbers: | D-0453 |
| Study First Received: | July 29, 2005 |
| Last Updated: | January 8, 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 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 May 23, 2013