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TerminatedPhase 2NCT00592007
Official study title

Study Evaluating the Addition of Fulvestrant to Erlotinib in Stage IIIB/IV Non-Small Cell Lung Cancer

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedFulvestrant and Erlotinib

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

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

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Lyudmila Bazhenova, M.D.

Study sponsor

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.

Cancer type
Non-small cell lung cancer (NSCLC)→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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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