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Trial record 1 of 1 for:    11357145 [PUBMED-IDS]
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Phase II Study of Clinical Activity of Pegaspargase in Women With Relapsed or Refractory Epithelial Ovarian Cancer, Fallopian Tube Cancer, and/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: NCT01313078
Recruitment Status : Completed
First Posted : March 11, 2011
Results First Posted : September 12, 2012
Last Update Posted : October 9, 2015
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Ovarian Neoplasms
Fallopian Tube Neoplasms
Primary Peritoneal Neoplasms
Intervention Drug: Pegylated L-Asparaginase
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pegaspargase in Women With Cancer
Hide Arm/Group Description Pegaspargase 2000 IU/m^2 intramuscular or intravenously every 2 weeks
Period Title: Overall Study
Started 4
Completed 1
Not Completed 3
Reason Not Completed
Death             1
Discontinued study drug             1
Withdrawal by Subject             1
Arm/Group Title Pegaspargase in Women With Cancer
Hide Arm/Group Description Pegaspargase 2000 IU/m^2 intramuscular or intravenously every 2 weeks
Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
  75.0%
>=65 years
1
  25.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants
52.1  (12.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
4
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
4
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
4
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
1.Primary Outcome
Title 6 Month Progression Free Survival
Hide Description Proportion of patients able to attain a 6 month progression free survival. Progressive disease is defined as >20% increase in the sum of the longest diameter of all target lesions, or the unequivocal increase in size of non-measurable lesions agreed upon by two investigators, or the appearance of new lesions.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pegaspargase in Women With Cancer
Hide Arm/Group Description:
Pegaspargase 2000 IU/m^2 intramuscular or intravenously every 2 weeks
Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: Participants
0
2.Primary Outcome
Title Evaluation of Safety in Patients With Ovarian, Fallopian Tube, and/or Primary Peritoneal Cancer.
Hide Description Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.
Time Frame 11 months, 25 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pegaspargase in Women With Cancer
Hide Arm/Group Description:
Pegaspargase 2000 IU/m^2 intramuscular or intravenously every 2 weeks
Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: Participants
4
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pegaspargase in Women With Cancer
Hide Arm/Group Description Pegaspargase 2000 IU/m^2 intramuscular or intravenously every 2 weeks
All-Cause Mortality
Pegaspargase in Women With Cancer
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pegaspargase in Women With Cancer
Affected / at Risk (%) # Events
Total   2/4 (50.00%)    
Immune system disorders   
Allergic reaction  1  1/4 (25.00%)  1
Respiratory, thoracic and mediastinal disorders   
Pleural effusion  1  1/4 (25.00%)  1
Indicates events were collected by 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%
Pegaspargase in Women With Cancer
Affected / at Risk (%) # Events
Total   4/4 (100.00%)    
Gastrointestinal disorders   
Nausea  1  2/4 (50.00%)  2
Abdominal pain  1  1/4 (25.00%)  1
Bloating  1  1/4 (25.00%)  1
Gastrointestinal disorders - Other, specify (Urgency bowel movement)  1  1/4 (25.00%)  1
Hemorrhoidal hemorrhage  1  1/4 (25.00%)  1
Toothache  1  1/4 (25.00%)  1
Vomiting  1  1/4 (25.00%)  1
Diarrhea  1  1/4 (25.00%)  1
Dyspepsia  1  1/4 (25.00%)  1
General disorders   
Fatigue  1  2/4 (50.00%)  2
Investigations   
Activated partial thromboplastin time prolonged  1  1/4 (25.00%)  1
Alanine aminotransferase increased  1  2/4 (50.00%)  2
Alkaline phosphatase increased  1  2/4 (50.00%)  2
Aspartate aminotransferase increased  1  2/4 (50.00%)  2
Blood bilirubin increased  1  2/4 (50.00%)  2
Fibrinogen decreased  1  2/4 (50.00%)  4
Investigations-Other, specify (PT, high)  1  1/4 (25.00%)  1
Lipase increased  1  1/4 (25.00%)  1
Lymphocyte count decreased  1  1/4 (25.00%)  1
Neutrophil count decreased  1  1/4 (25.00%)  1
Weight loss  1  1/4 (25.00%)  2
Metabolism and nutrition disorders   
Anorexia  1  2/4 (50.00%)  2
Dehydration  1  1/4 (25.00%)  1
Hyperglycemia  1  1/4 (25.00%)  1
Hyperkalemia  1  1/4 (25.00%)  1
Hypoalbuminemia  1  2/4 (50.00%)  3
Hypocalcemia  1  1/4 (25.00%)  1
Hyponatremia  1  1/4 (25.00%)  1
Hypophosphatemia  1  1/4 (25.00%)  1
Nervous system disorders   
Tremor  1  1/4 (25.00%)  1
Psychiatric disorders   
Agitation  1  1/4 (25.00%)  1
Insomnia  1  1/4 (25.00%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  1/4 (25.00%)  1
Pleural effusion  1  1/4 (25.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
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
Layout table for Results Point of Contact information
Name/Title: Elise Kohn, M.D.
Organization: National Cancer Institute, National Institutes of Health
Phone: 301-496-9336
EMail: kohne@mail.nih.gov
Layout table for additonal information
Responsible Party: Elise C. Kohn, M.D./National Cancer Institute, National Institutes of Health
ClinicalTrials.gov Identifier: NCT01313078     History of Changes
Other Study ID Numbers: 100028
10-C-0028
First Submitted: March 9, 2011
First Posted: March 11, 2011
Results First Submitted: August 13, 2012
Results First Posted: September 12, 2012
Last Update Posted: October 9, 2015