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Trial record 21 of 533 for:    "Primary Peritoneal Carcinoma"

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:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

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
Enrollment 22
Recruitment Details GOG 170Q accrued 22 patients from November 2010 to January 2013.
Pre-assignment Details  
Arm/Group Title Treatment (EGEN-001)
Hide Arm/Group Description

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

Period Title: Overall Study
Started 22
Completed 20
Not Completed 2
Reason Not Completed
Never treated             2
Arm/Group Title Treatment (EGEN-001)
Hide Arm/Group Description

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

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
Eligible and treated patients
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
< 40 years
0
   0.0%
40 - 49 years
1
   5.0%
50 - 59 years
12
  60.0%
60 - 69 years
5
  25.0%
70 - 79 years
2
  10.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
20
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Patients Who Survive Progression-free for at Least 6 Months
Hide Description Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression
Time Frame Every other cycle during treatment, then every 3 months until disese progression is confirmed, up to 5 years
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Hide Analysis Population Description
Eligible and treated patients
Arm/Group Title Treatment (EGEN-001)
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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

Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
Patients with Progression Free Survival > 6 months
6
  30.0%
Patients with Progression Free Survival < 6 months
14
  70.0%
2.Primary Outcome
Title Patients Who Have Objective Tumor Response (Complete or Partial Response)
Hide Description Complete and Partial Tumor Response by RECIST 1.1. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
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
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Hide Analysis Population Description
Eligible and Treated patients
Arm/Group Title Treatment (EGEN-001)
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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

Overall Number of Participants Analyzed 20
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
0.0
(0.0 to 13.9)
3.Primary Outcome
Title Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0
Hide Description Adverse events are listed by adverse event and grade. The number of participants affected is listed.
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
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Hide Analysis Population Description
Eligible and evaluable patients
Arm/Group Title Grade 0 Grade 1 (CTCAE v 4.0) Grade 2 (CTCAE v 4.0) Grade 3 (CTCAE v 4.0) Grade 4 (CTCAE v 4.0) Grade 5 (CTCAE v 4.0)
Hide Arm/Group Description:
Number of patients who did not experience the specified AE.
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 4.0
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 4.0
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 4.0
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 4.0
Overall Number of Participants Analyzed 20 20 20 20 20 20
Measure Type: Count of Participants
Unit of Measure: Participants
Ear and labyrinth
18
  90.0%
1
   5.0%
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
Eye
18
  90.0%
2
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Nausea
6
  30.0%
10
  50.0%
3
  15.0%
1
   5.0%
0
   0.0%
0
   0.0%
Vomiting
13
  65.0%
6
  30.0%
0
   0.0%
1
   5.0%
0
   0.0%
0
   0.0%
Abdominal pain
13
  65.0%
4
  20.0%
1
   5.0%
2
  10.0%
0
   0.0%
0
   0.0%
Other GI
12
  60.0%
6
  30.0%
2
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
Fever
16
  80.0%
3
  15.0%
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
Chills
16
  80.0%
4
  20.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Fatigue
9
  45.0%
7
  35.0%
4
  20.0%
0
   0.0%
0
   0.0%
0
   0.0%
General, NOS
15
  75.0%
1
   5.0%
4
  20.0%
0
   0.0%
0
   0.0%
0
   0.0%
Administrative site
17
  85.0%
1
   5.0%
2
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
Infections/infestations
19
  95.0%
0
   0.0%
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
Anorexia
17
  85.0%
3
  15.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Dehydration
18
  90.0%
0
   0.0%
2
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
Musculoskeletal/connective tissue
17
  85.0%
2
  10.0%
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
Peripheral Sensory neuropathy
17
  85.0%
2
  10.0%
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
Other nervous system
17
  85.0%
3
  15.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Psychiatric
17
  85.0%
3
  15.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Reproductive/breast
19
  95.0%
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Respiratory/thoracic/mediastinal
18
  90.0%
1
   5.0%
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
Skin/subcutaneous
16
  80.0%
4
  20.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Leukopenia
15
  75.0%
3
  15.0%
2
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
Lymphopenia
18
  90.0%
0
   0.0%
1
   5.0%
1
   5.0%
0
   0.0%
0
   0.0%
Neutropenia
15
  75.0%
5
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Thrombocytopenia
13
  65.0%
6
  30.0%
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
Anemia
9
  45.0%
5
  25.0%
5
  25.0%
1
   5.0%
0
   0.0%
0
   0.0%
Hyponatremia
19
  95.0%
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Elevated Creatinine
18
  90.0%
1
   5.0%
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hyperglycemia
19
  95.0%
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hypomagnesemia
18
  90.0%
2
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hypoalbuminemia
19
  95.0%
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Elevated alanine aminotransferase
19
  95.0%
0
   0.0%
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
Elevated alkaline phosphatase
18
  90.0%
2
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Elevated aspartate aminotransferase
18
  90.0%
1
   5.0%
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
Elevated GGT
19
  95.0%
0
   0.0%
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
Elevated bilirubin
19
  95.0%
0
   0.0%
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Overall Survival
Hide Description The observed length of life from entry into the study to death or the date of last contact.
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
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients
Arm/Group Title Treatment (EGEN-001)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 20
Median (90% Confidence Interval)
Unit of Measure: months
9.2
(5.7 to 16.3)
5.Secondary Outcome
Title Progression-free Survival
Hide Description The time from entry until disease progression, death, or date of last contact. Endpoints are progression or death. Patients who are not observed with an endpoint are censored.
Time Frame The duration of time from start of treatment to time of progression or death, whichever occurs first, assessed up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients
Arm/Group Title Treatment (EGEN-001)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 20
Median (90% Confidence Interval)
Unit of Measure: months
2.9
(2.0 to 6.3)
Time Frame All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (EGEN-001)
Hide Arm/Group Description

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

All-Cause Mortality
Treatment (EGEN-001)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (EGEN-001)
Affected / at Risk (%)
Total   9/20 (45.00%) 
Blood and lymphatic system disorders   
Anemia * 1  1/20 (5.00%) 
Gastrointestinal disorders   
Colonic Obstruction * 1  1/20 (5.00%) 
Vomiting * 1  1/20 (5.00%) 
Small Intestinal Obstruction * 1  3/20 (15.00%) 
Ileal Fistula * 1  1/20 (5.00%) 
General disorders   
Death Nos * 1  1/20 (5.00%) 
Injury, poisoning and procedural complications   
Fracture * 1  1/20 (5.00%) 
Investigations   
Creatinine Increased * 1  3/20 (15.00%) 
White Blood Cell Decreased * 1  1/20 (5.00%) 
Metabolism and nutrition disorders   
Hypoglycemia * 1  1/20 (5.00%) 
Musculoskeletal and connective tissue disorders   
Back Pain * 1  1/20 (5.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (EGEN-001)
Affected / at Risk (%)
Total   20/20 (100.00%) 
Blood and lymphatic system disorders   
Anemia * 1  15/20 (75.00%) 
Cardiac disorders   
Palpitations * 1  1/20 (5.00%) 
Ear and labyrinth disorders   
Tinnitus * 1  2/20 (10.00%) 
Hearing Impaired * 1  1/20 (5.00%) 
Ear Pain * 1  1/20 (5.00%) 
Endocrine disorders   
Hypothyroidism * 1  2/20 (10.00%) 
Hyperthyroidism * 1  1/20 (5.00%) 
Eye disorders   
Blurred Vision * 1  2/20 (10.00%) 
Gastrointestinal disorders   
Dyspepsia * 1  2/20 (10.00%) 
Constipation * 1  9/20 (45.00%) 
Diarrhea * 1  9/20 (45.00%) 
Vomiting * 1  8/20 (40.00%) 
Bloating * 1  1/20 (5.00%) 
Anal Hemorrhage * 1  1/20 (5.00%) 
Abdominal Pain * 1  9/20 (45.00%) 
Rectal Hemorrhage * 1  1/20 (5.00%) 
Abdominal Distension * 1  1/20 (5.00%) 
Nausea * 1  15/20 (75.00%) 
Gastroesophageal Reflux Disease * 1  1/20 (5.00%) 
General disorders   
Pain * 1  6/20 (30.00%) 
Malaise * 1  3/20 (15.00%) 
Injection Site Reaction * 1  1/20 (5.00%) 
Infusion Site Extravasation * 1  2/20 (10.00%) 
Flu Like Symptoms * 1  1/20 (5.00%) 
Fatigue * 1  13/20 (65.00%) 
Fever * 1  4/20 (20.00%) 
Chills * 1  4/20 (20.00%) 
Infections and infestations   
Sepsis * 1  1/20 (5.00%) 
Urinary Tract Infection * 1  4/20 (20.00%) 
Injury, poisoning and procedural complications   
Fall * 1  1/20 (5.00%) 
Investigations   
Weight Loss * 1  2/20 (10.00%) 
Platelet Count Decreased * 1  7/20 (35.00%) 
Lymphocyte Count Decreased * 1  2/20 (10.00%) 
Ggt Increased * 1  1/20 (5.00%) 
Creatinine Increased * 1  6/20 (30.00%) 
Neutrophil Count Decreased * 1  5/20 (25.00%) 
Blood Bilirubin Increased * 1  1/20 (5.00%) 
White Blood Cell Decreased * 1  5/20 (25.00%) 
Aspartate Aminotransferase Increased * 1  3/20 (15.00%) 
Alkaline Phosphatase Increased * 1  4/20 (20.00%) 
Alanine Aminotransferase Increased * 1  2/20 (10.00%) 
Metabolism and nutrition disorders   
Hyponatremia * 1  1/20 (5.00%) 
Hypomagnesemia * 1  5/20 (25.00%) 
Hypokalemia * 1  2/20 (10.00%) 
Hypocalcemia * 1  1/20 (5.00%) 
Hypoalbuminemia * 1  5/20 (25.00%) 
Hyperglycemia * 1  5/20 (25.00%) 
Dehydration * 1  2/20 (10.00%) 
Anorexia * 1  5/20 (25.00%) 
Musculoskeletal and connective tissue disorders   
Pain In Extremity * 1  1/20 (5.00%) 
Myalgia * 1  2/20 (10.00%) 
Muscle Weakness Lower Limb * 1  1/20 (5.00%) 
Generalized Muscle Weakness * 1  1/20 (5.00%) 
Bone Pain * 1  1/20 (5.00%) 
Back Pain * 1  4/20 (20.00%) 
Nervous system disorders   
Peripheral Sensory Neuropathy * 1  4/20 (20.00%) 
Memory Impairment * 1  1/20 (5.00%) 
Lethargy * 1  1/20 (5.00%) 
Headache * 1  2/20 (10.00%) 
Syncope * 1  1/20 (5.00%) 
Dizziness * 1  2/20 (10.00%) 
Depressed Level Of Consciousness * 1  1/20 (5.00%) 
Psychiatric disorders   
Insomnia * 1  5/20 (25.00%) 
Depression * 1  1/20 (5.00%) 
Renal and urinary disorders   
Urinary Frequency * 1  2/20 (10.00%) 
Bladder Spasm * 1  1/20 (5.00%) 
Reproductive system and breast disorders   
Vaginal Pain * 1  1/20 (5.00%) 
Vaginal Discharge * 1  1/20 (5.00%) 
Menopause * 1  1/20 (5.00%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea * 1  2/20 (10.00%) 
Cough * 1  3/20 (15.00%) 
Skin and subcutaneous tissue disorders   
Skin And Subcutaneous Tissue Disorders - Other * 1  2/20 (10.00%) 
Pruritus * 1  2/20 (10.00%) 
Rash Maculo-Papular * 1  1/20 (5.00%) 
Nail Ridging * 1  1/20 (5.00%) 
Dry Skin * 1  2/20 (10.00%) 
Bullous Dermatitis * 1  1/20 (5.00%) 
Vascular disorders   
Thromboembolic Event * 1  1/20 (5.00%) 
Hypotension * 1  2/20 (10.00%) 
Hypertension * 1  2/20 (10.00%) 
Hot Flashes * 1  1/20 (5.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Linda Gedeon for Michael Sill, PhD
Organization: NRG Oncology
Phone: 716-845-1169
EMail: lgedeon@gogstats.org
Layout table for additonal information
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