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 — DRUG
    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.

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: A
    Single-arm study

Primary Outcome Measure

Progression-free Survival [ Time Frame: 14 weeks after start of fulvestrant ]

Locations (1)

FacilityCityStateZIPSite coordinators
Moores UCSD Cancer CenterLa JollaCalifornia92093-0698-

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