Erlotinib With or Without Fulvestrant in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
NCT00100854 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108
Last updated 2019-03-05
Summary
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of non-small cell lung cancer cells. Hormone therapy using fulvestrant may fight non-small cell lung cancer by lowering the amount of estrogen the body makes. Giving erlotinib together with fulvestrant may kill more tumor cells. It is not yet known whether giving erlotinib together with fulvestrant is more effective than erlotinib alone in treating non-small cell lung cancer.
PURPOSE: This randomized phase II trial is studying giving erlotinib together with fulvestrant to see how well it works compared to erlotinib alone in treating patients with stage IIIB or stage IV non-small cell lung cancer.
Conditions
Interventions
- DRUG
-
erlotinib hydrochloride
Given orally
- DRUG
-
Given intramuscularly
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Translational Oncology Research International
lead OTHER
Principal Investigators
-
Edward Garon, MD · Jonsson Comprehensive Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-10-28
- Primary Completion
- 2018-09-05
- Completion
- 2018-09-05
Countries
- United States
Study Locations
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