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:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Lyudmila Bazhenova, M.D., University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00592007
First received: December 26, 2007
Last updated: July 12, 2012
Last verified: July 2012
  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: 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

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 14 weeks after start of fulvestrant ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 7
Study Start Date: September 2007
Estimated Study Completion Date: July 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

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
Study First Received: December 26, 2007
Last Updated: July 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Estrogens
Estradiol
Progesterone
Fulvestrant
Erlotinib
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Progestins
Antineoplastic Agents
Therapeutic Uses
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Antineoplastic Agents, Hormonal
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on July 20, 2014