Study Evaluating the Addition of Fulvestrant to Erlotinib in Stage IIIB/IV Non-Small Cell Lung Cancer
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial Evaluating Addition of Fulvestrant to Erlotinib in Patients With Stage IIIB/IV NSCLC Who Are Stable on Erlotinib and Exhibit Positivity for Estrogen or Progesterone Receptor|
- Progression-free survival [ Time Frame: 14 weeks after start of fulvestrant ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Patients will be followed until death ] [ Designated as safety issue: No ]
- Compare progression-free survival and time to progression with historical controls from similar patients at the Moores UCSD Cancer Center [ Time Frame: 14 weeks after start of fulvestrant ] [ Designated as safety issue: No ]
- Response rate [ Time Frame: Response assessment every 2 months ] [ Designated as safety issue: No ]
- Compare the progression-free survival using fulvestrant in addition to erlotinib with comparable historical controls on monotherapy alone from the original phase III efficacy trial of erlotinib [ Time Frame: 14 weeks after start of fulvestrant ] [ Designated as safety issue: No ]
- Monitor the toxicities of the combination of fulvestrant and erlotinib [ Time Frame: Day 14 and 28 of Cycle 1 and Day 1 of each subsequent cycles ] [ Designated as safety issue: Yes ]
- Study the association between tumor response ER or PR positivity by IHC [ Time Frame: one-time measurement ] [ Designated as safety issue: No ]
- Study the association between tumor response and ER alpha and beta expression by PCR [ Time Frame: one-time measurement ] [ Designated as safety issue: No ]
- Study the association between gender and ER alpha and beta expression as determined by IHC or PCR [ Time Frame: one-time measurement ] [ Designated as safety issue: No ]
|Study Start Date:||September 2007|
|Estimated Study Completion Date:||July 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
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.
Other Name: Faslodex and Erlotinib
Erlotinib is an oral drug which is able to block endothelial growth factor receptor (EGFR). EGFR stimulates cancer cell growth. Fulvestrant (faslodex) block estrogen hormone from gaining access to tumor and stimulating the tumor cells to grow. Both of these drugs are already approved by FDA but have not been studied in this combination.
We will study if the combination of these drugs will delay treatment failure. Lung cancer tumors in both males and females can be sensitive to estrogen. Only patients whose tumor expresses the estrogen will be eligible for the trial. Estrogen sensitivity will be tested on previously removed tumor specimens.
|United States, California|
|Moores UCSD Cancer Center|
|La Jolla, California, United States, 92093-0698|
|Principal Investigator:||Lyudmila Bazhenova, M.D.||University of California, San Diego|