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

This study has been terminated.
(Study was terminated due to slow subject accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00592007
First Posted: January 11, 2008
Last Update Posted: June 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Lyudmila Bazhenova, M.D., University of California, San Diego
  Purpose
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.

Condition Intervention Phase
Non Small Cell Lung Carcinoma Drug: Fulvestrant and Erlotinib Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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

Resource links provided by NLM:


Further study details as provided by Lyudmila Bazhenova, M.D., University of California, San Diego:

Primary Outcome Measures:
  • Progression-free Survival [ Time Frame: 14 weeks after start of fulvestrant ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: Patients will be followed until death ]

Enrollment: 7
Study Start Date: September 2007
Study Completion Date: April 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Single-arm study
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

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00592007


Locations
United States, California
Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0698
Sponsors and Collaborators
Lyudmila Bazhenova, M.D.
AstraZeneca
Investigators
Principal Investigator: Lyudmila Bazhenova, M.D. University of California, San Diego
  More Information

Additional Information:
Responsible Party: Lyudmila Bazhenova, M.D., Assistant Clinical Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00592007     History of Changes
Other Study ID Numbers: UCSD-060769
HRPP# 060769
First Submitted: December 26, 2007
First Posted: January 11, 2008
Results First Submitted: November 26, 2016
Results First Posted: June 6, 2017
Last Update Posted: June 6, 2017
Last Verified: May 2017

Keywords provided by Lyudmila Bazhenova, M.D., University of California, San Diego:
Non Small Cell Lung Cancer
Stage IIIB
Stage IV
Stable on Erlotinib
Exhibit Positivity for Estrogen or Progesterone Receptor

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Fulvestrant
Erlotinib Hydrochloride
Progesterone
Estradiol
Estrogens
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists