Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 57 of 526 for:    "Primary Peritoneal Carcinoma"

A6 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: NCT00939809
Recruitment Status : Completed
First Posted : July 15, 2009
Results First Posted : July 17, 2014
Last Update Posted : January 15, 2019
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
Malignant Ovarian Mixed Epithelial Tumor
Ovarian Brenner Tumor
Ovarian Clear Cell Cystadenocarcinoma
Ovarian Endometrioid Adenocarcinoma
Ovarian Mucinous Cystadenocarcinoma
Ovarian Serous Cystadenocarcinoma
Primary Peritoneal Carcinoma
Recurrent Ovarian Carcinoma
Undifferentiated Ovarian Carcinoma
Interventions Biological: Urokinase-Derived Peptide A6
Other: Laboratory Biomarker Analysis
Enrollment 31
Recruitment Details The study was activated on 7/6/2009 and closed to accrual on 1/4/2010.
Pre-assignment Details  
Arm/Group Title A6 (Subcutaneous)
Hide Arm/Group Description 300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
Period Title: Overall Study
Started 31
Completed 28 [1]
Not Completed 3
Reason Not Completed
Adverse Event             2
Death             1
[1]
Patients treated until disease progression; completed defined as off treatment due to progression.
Arm/Group Title A6 (Subcutaneous)
Hide Arm/Group Description 300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
Overall Number of Baseline Participants 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 31 participants
40-49 years 1
50-59 years 11
60-69 years 17
70-79 years 2
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Female
31
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Progression-free Survival at 6 Months
Hide Description

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.

CT scan or MRI is used to follow lesion for measurable disease 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. Responses must be confirmed by repeat imaging 4 weeks following documentation of response.

Time Frame Scans to assess progression were done every other cycle for the first 6 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated participants
Arm/Group Title A6 (Subcutaneous)
Hide Arm/Group Description:
300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
Overall Number of Participants Analyzed 31
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
6.5
(1.2 to 18.9)
2.Primary Outcome
Title Tumor Response
Hide Description

Complete and Partial Tumor Response by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Per RECIST v1.0 for target lesions and assessed by MRI or CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.

CT scan or MRI is used to follow lesion for measurable disease 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. Responses must be confirmed by repeat imaging 4 weeks following documentation of 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated participants
Arm/Group Title A6 (Subcutaneous)
Hide Arm/Group Description:
300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
Overall Number of Participants Analyzed 31
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 9.2)
3.Primary Outcome
Title Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Hide Description [Not Specified]
Time Frame Every cycle during treatment (average collection time = 4 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and Treated Patients
Arm/Group Title A6 (Subcutaneous)
Hide Arm/Group Description:
300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
Overall Number of Participants Analyzed 31
Measure Type: Count of Participants
Unit of Measure: Participants
Constitutional
2
   6.5%
Gastrointestinal
1
   3.2%
Hemorrhage
1
   3.2%
4.Secondary Outcome
Title Progression-free Survival
Hide Description

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.

CT scan or MRI is used to follow lesion for measurable disease 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. Responses must be confirmed by repeat imaging 4 weeks following documentation of 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated participants
Arm/Group Title A6 (Subcutaneous)
Hide Arm/Group Description:
300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
Overall Number of Participants Analyzed 31
Median (95% Confidence Interval)
Unit of Measure: months
2.0
(1.8 to 3.0)
5.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame Every other cycle, up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated participants
Arm/Group Title A6 (Subcutaneous)
Hide Arm/Group Description:
300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
Overall Number of Participants Analyzed 31
Median (95% Confidence Interval)
Unit of Measure: months
10.6 [1] 
(8.4 to NA)
[1]
NA (not applicable): insufficient number of participants with events.
6.Secondary Outcome
Title Biomarkers of Drug Effect on Peripheral Blood Mononuclear Cells (PBMCs)
Hide Description Note: due to the limited activity of this agent, it was decided not to expend resources assaying the PBMCs. Data was not collected.
Time Frame Day 1 prior to dosing; Day 2 prior to dosing and 4-hour post dosing; Day 8 prior to dosing.
Hide Outcome Measure Data
Hide Analysis Population Description
due to the limited activity of this agent, it was decided not to expend resources assaying the PBMCs.
Arm/Group Title A6 (Subcutaneous)
Hide Arm/Group Description:
300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events were queried for and collected every cycle for the duration of treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title A6 (Subcutaneous)
Hide Arm/Group Description 300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
All-Cause Mortality
A6 (Subcutaneous)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
A6 (Subcutaneous)
Affected / at Risk (%)
Total   9/31 (29.03%) 
Gastrointestinal disorders   
Distention  1/31 (3.23%) 
Anorexia  2/31 (6.45%) 
General disorders   
Death No Ctcae Term - Sudden Death  1/31 (3.23%) 
Pain: Back  1/31 (3.23%) 
Hepatobiliary disorders   
Cholecystitis  1/31 (3.23%) 
Infections and infestations   
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos  1/31 (3.23%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Nerve-Peripheral  1/31 (3.23%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary: Other  1/31 (3.23%) 
Vascular disorders   
Hemorrhage, Cns  1/31 (3.23%) 
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
A6 (Subcutaneous)
Affected / at Risk (%)
Total   29/31 (93.55%) 
Blood and lymphatic system disorders   
Neutrophils  5/31 (16.13%) 
Platelets  5/31 (16.13%) 
Leukocytes  5/31 (16.13%) 
Lymphopenia  1/31 (3.23%) 
Hemoglobin  17/31 (54.84%) 
Edema: Trunk/Genital  1/31 (3.23%) 
Edema: Limb  2/31 (6.45%) 
Cardiac disorders   
Hypertension  4/31 (12.90%) 
Ear and labyrinth disorders   
Hearing (Without Monitoring Program)  1/31 (3.23%) 
Tinnitus  1/31 (3.23%) 
Endocrine disorders   
Hot Flashes  1/31 (3.23%) 
Eye disorders   
Flashing Lights/Floaters  1/31 (3.23%) 
Gastrointestinal disorders   
Flatulence  1/31 (3.23%) 
Heartburn  1/31 (3.23%) 
Dysphagia  1/31 (3.23%) 
Distention  3/31 (9.68%) 
Vomiting  4/31 (12.90%) 
Anorexia  5/31 (16.13%) 
Constipation  7/31 (22.58%) 
Nausea  9/31 (29.03%) 
Diarrhea  2/31 (6.45%) 
General disorders   
Sweating  1/31 (3.23%) 
Weight Gain  2/31 (6.45%) 
Fever  1/31 (3.23%) 
Fatigue  14/31 (45.16%) 
Insomnia  2/31 (6.45%) 
Pain - Other  2/31 (6.45%) 
Pain: Pelvis  1/31 (3.23%) 
Pain: Head/Headache  3/31 (9.68%) 
Pain: Extremity-Limb  1/31 (3.23%) 
Pain: Back  6/31 (19.35%) 
Pain: Joint  4/31 (12.90%) 
Pain: Bladder  1/31 (3.23%) 
Pain: Abdominal Pain Nos  13/31 (41.94%) 
Pain: Skin  1/31 (3.23%) 
Pain: Muscle  1/31 (3.23%) 
Infections and infestations   
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos  1/31 (3.23%) 
Metabolism and nutrition disorders   
Ast  2/31 (6.45%) 
Gfr  1/31 (3.23%) 
Metabolic/Laboratory - Other  1/31 (3.23%) 
Creatinine  2/31 (6.45%) 
Hypoalbuminemia  1/31 (3.23%) 
Alt  1/31 (3.23%) 
Alkaline Phosphatase  2/31 (6.45%) 
Bilirubin  1/31 (3.23%) 
Lipase  1/31 (3.23%) 
Hyponatremia  3/31 (9.68%) 
Hyperuricemia  1/31 (3.23%) 
Amylase  1/31 (3.23%) 
Hypocalcemia  1/31 (3.23%) 
Hyperglycemia  3/31 (9.68%) 
Hypokalemia  2/31 (6.45%) 
Hypomagnesemia  2/31 (6.45%) 
Nervous system disorders   
Mood Alteration - Depression  1/31 (3.23%) 
Mood Alteration - Anxiety  2/31 (6.45%) 
Tremor  1/31 (3.23%) 
Confusion  1/31 (3.23%) 
Dizziness  1/31 (3.23%) 
Neuropathy-Sensory  6/31 (19.35%) 
Renal and urinary disorders   
Leak, Gu - Urethra  1/31 (3.23%) 
Urinary Retention  1/31 (3.23%) 
Bladder Spasm  1/31 (3.23%) 
Urinary Frequency  1/31 (3.23%) 
Respiratory, thoracic and mediastinal disorders   
Cough  2/31 (6.45%) 
Pleural Effusion  1/31 (3.23%) 
Dyspnea  3/31 (9.68%) 
Skin and subcutaneous tissue disorders   
Nail Changes  1/31 (3.23%) 
Injection Site Reaction  3/31 (9.68%) 
Hair Loss/Alopecia (Scalp Or Body)  2/31 (6.45%) 
Bruising  3/31 (9.68%) 
Rash  1/31 (3.23%) 
Dry Skin  1/31 (3.23%) 
Vascular disorders   
Hemorrhage, Gu - Vagina  1/31 (3.23%) 
Hemorrhage, Gi - Rectum  1/31 (3.23%) 
Hematoma  1/31 (3.23%) 
Thrombosis/Thrombus/Embolism  1/31 (3.23%) 
1
Term from vocabulary, CTCAE (3.0)
Note: due to the limited activity of this agent, it was decided not to expend resources assaying the PBMCs.
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
Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00939809     History of Changes
Other Study ID Numbers: GOG-0170N
NCI-2011-01927 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
GOG-0170N
CDR0000644399
GOG-0170N ( Other Identifier: Gynecologic Oncology Group )
GOG-0170N ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: July 14, 2009
First Posted: July 15, 2009
Results First Submitted: February 3, 2014
Results First Posted: July 17, 2014
Last Update Posted: January 15, 2019