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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
Results First Submitted: November 26, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Non Small Cell Lung Carcinoma
Intervention: Drug: Fulvestrant and Erlotinib

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Fulvestrand and Erlotinib

Single-arm study

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.


Participant Flow:   Overall Study
    Fulvestrand and Erlotinib
STARTED   7 
COMPLETED   5 
NOT COMPLETED   2 
Withdrawal by Subject                1 
patient ineligible (out of lab range)                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Fulvestrant and Erlotinib

Single-arm study

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.


Baseline Measures
   Fulvestrant and Erlotinib 
Overall Participants Analyzed 
[Units: Participants]
 7 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      2  28.6% 
>=65 years      5  71.4% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      2  28.6% 
Male      5  71.4% 
Region of Enrollment 
[Units: Participants]
 
United States   7 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-free Survival   [ Time Frame: 14 weeks after start of fulvestrant ]

2.  Secondary:   Overall Survival   [ Time Frame: Patients will be followed until death ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Lyudmila Bazhenova, MD
Organization: UC San Diego, Moores Cancer Center
phone: 858 822 6189
e-mail: lbazhenova@ucsd.edu



Responsible Party: Lyudmila Bazhenova, M.D., 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