Study Evaluating the Addition of Fulvestrant to Erlotinib in Stage IIIB/IV Non-Small Cell Lung Cancer
NCT00592007 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7
Last updated 2017-06-06
Summary
The main purpose of this research study is to see if adding fulvestrant (Faslodex) to erlotinib (Tarceva) is effective in patients with stage IIIb/IV Non-Small Cell Lung Cancer.
Conditions
- Non Small Cell Lung Carcinoma
Interventions
- DRUG
-
Fulvestrant and Erlotinib
Upon enrollment, patients will continue to receive erlotinib daily orally at 150 mg/day or at 100 mg/day if 150 mg was associated with adverse events requiring dose reduction before enrollment in this study. Doses less than 100 mg/day will not be allowed. Fulvestrant will be added intramuscularly 500 mg Day 0, 250 mg Days 14 and 28. In cycles 2 and up, fulvestrant will be given 250 mg on day 28. Patients will receive this therapy until they progress.
Sponsors & Collaborators
- collaborator INDUSTRY
-
Lyudmila Bazhenova, M.D.
lead OTHER
Principal Investigators
-
Lyudmila Bazhenova, M.D. · University of California, San Diego
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-09-30
- Primary Completion
- 2012-01-31
- Completion
- 2012-04-30
Countries
- United States
Study Locations
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