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EGEN-001 in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

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.
ClinicalTrials.gov Identifier: NCT01118052
Recruitment Status : Completed
First Posted : May 6, 2010
Results First Posted : November 30, 2017
Last Update Posted : January 11, 2018
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Fallopian Tube Carcinoma
Primary Peritoneal Carcinoma
Recurrent Ovarian Carcinoma
Interventions: Other: Laboratory Biomarker Analysis
Biological: PEG-PEI-cholesterol Lipopolymer-encased IL-12 DNA Plasmid Vector GEN-1

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
GOG 170Q accrued 22 patients from November 2010 to January 2013.

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
Treatment (EGEN-001)

Patients receive intraperitoneal EGEN-001 on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

PEG-PEI-cholesterol Lipopolymer-encased IL-12 DNA Plasmid Vector GEN-1: Given intraperitoneally


Participant Flow:   Overall Study
    Treatment (EGEN-001)
STARTED   22 
COMPLETED   20 
NOT COMPLETED   2 
Never treated                2 



  Baseline Characteristics

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.
Eligible and treated patients

Reporting Groups
  Description
Treatment (EGEN-001)

Patients receive intraperitoneal EGEN-001 on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

PEG-PEI-cholesterol Lipopolymer-encased IL-12 DNA Plasmid Vector GEN-1: Given intraperitoneally


Baseline Measures
   Treatment (EGEN-001) 
Overall Participants Analyzed 
[Units: Participants]
 20 
Age, Customized 
[Units: Participants]
Count of Participants
 
< 40 years   0 
40 - 49 years   1 
50 - 59 years   12 
60 - 69 years   5 
70 - 79 years   2 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      20 100.0% 
Male      0   0.0% 


  Outcome Measures

1.  Primary:   Patients Who Survive Progression-free for at Least 6 Months   [ Time Frame: Every other cycle during treatment, then every 3 months until disese progression is confirmed, up to 5 years ]

2.  Primary:   Patients Who Have Objective Tumor Response (Complete or Partial Response)   [ Time Frame: CT or MRI used to follow lesion for measurable disease every other cycle. Patient's best response while on study treatment was recorded, Up to 5 years ]

3.  Primary:   Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0   [ Time Frame: All Adverse Events (AEs) deemed at least possibly related to study treatmetn occurring during treatment and up to 30 days after stopping the study treatment. for up to 5 years after stopping study treatment ]

4.  Secondary:   Overall Survival   [ Time Frame: The duration of time from start of treatment to time of death or the date of last contact, assessed up to 5 years ]

5.  Secondary:   Progression-free Survival   [ Time Frame: The duration of time from start of treatment to time of progression or death, whichever occurs first, assessed up to 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Linda Gedeon for Michael Sill, PhD
Organization: NRG Oncology
phone: 716-845-1169
e-mail: lgedeon@gogstats.org



Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01118052     History of Changes
Other Study ID Numbers: GOG-0170Q
NCI-2011-02041 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
FD-R-003942
CDR0000672159
GOG-0170Q ( Other Identifier: NRG Oncology )
GOG-0170Q ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: May 5, 2010
First Posted: May 6, 2010
Results First Submitted: November 2, 2017
Results First Posted: November 30, 2017
Last Update Posted: January 11, 2018