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

December 26, 2007
July 12, 2012
September 2007
January 2012   (final data collection date for primary outcome measure)
Progression-free survival [ Time Frame: 14 weeks after start of fulvestrant ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00592007 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study Evaluating the Addition of Fulvestrant to Erlotinib in Stage IIIB/IV Non-Small Cell Lung Cancer
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

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non Small Cell Lung Carcinoma
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
Experimental: A
Single-arm study
Intervention: Drug: Fulvestrant and Erlotinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
7
July 2012
January 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00592007
UCSD-060769, HRPP# 060769
Yes
Lyudmila Bazhenova, M.D., University of California, San Diego
Lyudmila Bazhenova, M.D.
AstraZeneca
Principal Investigator: Lyudmila Bazhenova, M.D. University of California, San Diego
University of California, San Diego
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP