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A6 in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00939809
First received: July 14, 2009
Last updated: June 17, 2014
Last verified: June 2014
Results First Received: February 3, 2014  
Study Type: Interventional
Study Design: Masking: Open Label;   Primary Purpose: Treatment
Conditions: Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Interventions: Biological: urokinase-derived peptide A6
Other: laboratory biomarker analysis

  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
The study was activated on 7/6/2009 and closed to accrual on 1/4/2010.

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
A6 (Subcutaneous) 300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy

Participant Flow:   Overall Study
    A6 (Subcutaneous)  
STARTED     31  
COMPLETED     28 [1]
NOT COMPLETED     3  
Adverse Event                 2  
Death                 1  
[1] Patients treated until disease progression; completed defined as off treatment due to progression.



  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
A6 (Subcutaneous) 300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy

Baseline Measures
    A6 (Subcutaneous)  
Number of Participants  
[units: participants]
  31  
Age, Customized  
[units: participants]
 
40-49 years     1  
50-59 years     11  
60-69 years     17  
70-79 years     2  
Gender  
[units: participants]
 
Female     31  
Male     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-free Survival at 6 Months   [ Time Frame: Scans to assess progression were done every other cycle for the first 6 months. ]

2.  Primary:   Tumor Response   [ Time Frame: Scans to assess response were done every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. ]

3.  Secondary:   Progression-free Survival   [ Time Frame: scans to assess response were done every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. ]

4.  Secondary:   Overall Survival   [ Time Frame: Every other cycle, up to 5 years ]

5.  Secondary:   Biomarkers of Drug Effect on Peripheral Blood Mononuclear Cells (PBMCs)   [ Time Frame: Day 1 prior to dosing; Day 2 prior to dosing and 4-hour post dosing; Day 8 prior to dosing. ]

6.  Primary:   Frequency and Severity of Adverse Events as Assessed by CTCAE v3.0   [ Time Frame: Every cycle during treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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
Note: due to the limited activity of this agent, it was decided not to expend resources assaying the PBMCs.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jessalyn Reboy
Organization: Gynecologic Oncology Group Statistical and Data Center
phone: 716-845-7738
e-mail: reboyj@nrgoncology.org


Publications of Results:

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00939809     History of Changes
Other Study ID Numbers: GOG-0170N, CDR0000644399, NCI-2011-01927
Study First Received: July 14, 2009
Results First Received: February 3, 2014
Last Updated: June 17, 2014
Health Authority: United States: Federal Government