TerminatedPhase 2NCT00592007

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.

Checked against the public recordLast updated Jun 6, 2017 · Source: ClinicalTrials.gov

StatusTerminated
PhasePhase 2
U.S. locations1
SponsorLyudmila Bazhenova, M.D.
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Lyudmila Bazhenova, M.D.
Interventions being studied
Drug: Fulvestrant and Erlotinib
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: * Estrogen or progesterone receptor positive stage IIIb/IV non-small cell lung cancer * Eligible patients will have stable disease on erlotinib monotherapy at FDA- approved doses after a minimum duration of erlotinib therapy of 2 months * 18 years or older * ECOG Performance Status ≤2 * Adequate Organ Function Requirements * Adequate coagulation function * Postmenopausal status in female patients is required and is defined as no menstrual periods for 12 month or surgical menopause * All patients must sign a written informed consent. Exclusion Criteria: * Pregnant or breast-feeding women will not be entered on this study * Patients who are currently receiving another investigational drugs * Patients who are currently receiving other anti-cancer agents. * Hormone replacement therapy will not be allowed and have to be stopped 1 month prior to entry into the study * Patients who have an uncontrolled infection. * Patients receiving less than 100mg/day of erlotinib * Patients with evidence of progression after 2 months of erlotinib monotherapy. * Patients with a history of bleeding diathesis (i.e., disseminated intravascular coagulation \[DIC\], clotting factor deficiency) or long-term anticoagulant therapy (other than antiplatelet therapy). * Patients with a history of hypersensitivity to active or inactive excipients of fulvestrant (i.e. castor oil or Mannitol). * Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Moores UCSD Cancer CenterLa Jolla, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 6, 2017. Always confirm current availability with the study team.

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