Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Fulvestrant and Anastrozole as Consolidation Therapy in Postmenopausal Women With Advanced Non-small Cell Lung Cancer

This study has been terminated.
(Poor enrollment/suspended to accrual; will close per AstraZeneca request)
Sponsor:
Information provided by (Responsible Party):
Ahmad Tarhini, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00932152
First received: July 1, 2009
Last updated: July 19, 2016
Last verified: July 2016
Results First Received: January 14, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Non-small Cell Lung Cancer
Postmenopausal Women
Interventions: Drug: fulvestrant (Faslodex)
Drug: anastrozole (Arimidex)
Drug: Bevacizumab (Avastin)
Drug: Best supportive care

  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 participants were randomized to the "Best supportive care only" and "Best supportive care with Bevacizumab" Arms due to low recruitment.

Reporting Groups
  Description
Fulvestrant and Anastrozole Only No text entered.
Fulvestrant, Anastrozole and Bevacizumab No text entered.

Participant Flow:   Overall Study
    Fulvestrant and Anastrozole Only   Fulvestrant, Anastrozole and Bevacizumab
STARTED   1   2 
COMPLETED   0   0 
NOT COMPLETED   1   2 



  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 Anastrozole Only No text entered.
Fulvestrant, Anastrozole and Bevacizumab No text entered.
Total Total of all reporting groups

Baseline Measures
   Fulvestrant and Anastrozole Only   Fulvestrant, Anastrozole and Bevacizumab   Total 
Overall Participants Analyzed 
[Units: Participants]
 1   2   3 
Age 
[Units: Years]
Mean (Full Range)
 67 
 (67 to 67) 
 67.5 
 (58 to 77) 
 67 
 (58 to 77) 
Gender 
[Units: Participants]
     
Female   1   2   3 
Male   0   0   0 


  Outcome Measures

1.  Primary:   To Evaluate the Progression-free Survival.   [ Time Frame: 1.5 years ]

2.  Secondary:   To Evaluate the Time to Overall Survival, Time to Progression, and Toxicities   [ Time Frame: 1.5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   To Evaluate the Levels of 17b-estradiol, VEGF, E-selectin, Thrombospondin-1 and IGF-1, and Other Biomarkers in the Plasma.   [ Time Frame: 1.5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   To Evaluate Biomarkers (ERa, ERb, PR, VEGF and Aromatase Expression) in Baseline, Archival Tumor Tissue and Correlate Their Expression With Progression-free Survival, Time to Progression, and Overall Survival.   [ Time Frame: 1.5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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: Ahmad Tarhini, MD
Organization: University of Pittsburgh
phone: (412) 648-6578
e-mail: tarhiniaa@upmc.edu



Responsible Party: Ahmad Tarhini, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00932152     History of Changes
Other Study ID Numbers: UPCI 08-131
Study First Received: July 1, 2009
Results First Received: January 14, 2016
Last Updated: July 19, 2016
Health Authority: United States: Institutional Review Board