Study Evaluating the Addition of Fulvestrant to Erlotinib in Stage IIIB/IV Non-Small Cell Lung Cancer
Part of paid clinical trials in La Jolla, California.
- Sponsor
- Lyudmila Bazhenova, M.D.
- Study ID
- NCT00592007
- Phase
- PHASE2
- Status
- Terminated
Conditions
- Non Small Cell Lung Carcinoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Fulvestrant and Erlotinib — DRUGUpon 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.
Study Details
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.
Key Dates
- First listed
- Jan 11, 2008
- Start date
- Sep 30, 2007
- Status verified
- May 2017
- Primary completion
- Jan 31, 2012
- Completion
- Apr 30, 2012
Study Design
- Enrollment
- 7 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: ASingle-arm study
Primary Outcome Measure
Progression-free Survival [ Time Frame: 14 weeks after start of fulvestrant ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Moores UCSD Cancer Center | La Jolla | California | 92093-0698 | - |
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