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Trial record 52 of 55 for:    "Anaplastic oligoastrocytoma"

Study of Capecitabine to Treat Recurrent High Grade Gliomas

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ClinicalTrials.gov Identifier: NCT00717197
Recruitment Status : Completed
First Posted : July 17, 2008
Results First Posted : March 25, 2013
Last Update Posted : July 2, 2013
Sponsor:
Information provided by (Responsible Party):
University of Florida

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Malignant Glioma
Intervention Drug: Capecitabine
Enrollment 30
Recruitment Details Participants were recruited from the investigator's clinical practice from October 2008 thru June 2011.
Pre-assignment Details 30 participants were enrolled in the study. 7 were excluded from participation prior to group assignment [5 were unable to purchase study drug; 1 had rapid tumor growth; and, 1 was withdrawn by the investigator for mental health reasons].
Arm/Group Title Capecitabine
Hide Arm/Group Description Capecitabine (1,000-1,250 mg/m2) was taken by mouth twice daily for 14 out of 21 consecutive days until disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 30
Completed 23
Not Completed 7
Reason Not Completed
Unable to purchase study drug             5
Tumor Progression             1
Physician Decision             1
Arm/Group Title Capecitabine
Hide Arm/Group Description Capecitabine (1,000-1,250 mg/m2) was taken by mouth twice daily for 14 out of 21 consecutive days until disease progression or unacceptable toxicity.
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
23
  76.7%
>=65 years
7
  23.3%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
51.5  (12.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
15
  50.0%
Male
15
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
1.Primary Outcome
Title Percentage of Participants With Progression-free Survival.
Hide Description Gadolinium-contrasted MRIs were used to assess radiographic response every 2 cycles (~6 weeks). Tumor progression was defined by increasing tumor size, new areas of tumor, or unequivocal neurologic deterioration.
Time Frame From date of first dose of study drug until month 6.
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol
Arm/Group Title Capecitabine
Hide Arm/Group Description:
Capecitabine (1,000-1,250 mg/m2) was taken by mouth twice daily for 14 out of 21 consecutive days until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 23
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants with PFS6
21.7
(7.46 to 43.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Capecitabine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage
Estimated Value 21.7
Confidence Interval (2-Sided) 95%
7.46 to 43.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.27
Estimation Comments [Not Specified]
Time Frame Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Capecitabine
Hide Arm/Group Description Capecitabine (1,000-1,250 mg/m2) was taken by mouth twice daily for 14 out of 21 consecutive days until disease progression or unacceptable toxicity.
All-Cause Mortality
Capecitabine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Capecitabine
Affected / at Risk (%) # Events
Total   21/23 (91.30%)    
Gastrointestinal disorders   
Vomiting  1  2/23 (8.70%) 
Dairrhea  1  1/23 (4.35%) 
General disorders   
Death  1  21/23 (91.30%)  21
Fever  1  1/23 (4.35%) 
Levetiracetam, Low Level  1  1/23 (4.35%) 
Phenytoin, High Level  1  1/23 (4.35%) 
Metabolism and nutrition disorders   
Hyponatremia  1  1/23 (4.35%) 
Musculoskeletal and connective tissue disorders   
Gait  1  1/23 (4.35%) 
Muscle Weakness  1  1/23 (4.35%) 
Nervous system disorders   
Mental Status  1  4/23 (17.39%) 
Ataxia  1  1/23 (4.35%) 
Skin and subcutaneous tissue disorders   
Rash  1  1/23 (4.35%) 
Indicates events were collected by systematic assessment
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%
Capecitabine
Affected / at Risk (%) # Events
Total   23/23 (100.00%)    
Blood and lymphatic system disorders   
Hemoglobin  1  4/23 (17.39%) 
Lymphopenia  1  1/23 (4.35%) 
Platelets  1  1/23 (4.35%) 
Leukocytes  1  2/23 (8.70%) 
Eye disorders   
Blindness  1  1/23 (4.35%) 
Blurred Vision  1  1/23 (4.35%) 
Gastrointestinal disorders   
Constipation  1  6/23 (26.09%) 
Diarrhea  1  6/23 (26.09%) 
Dysphagia  1  3/23 (13.04%) 
Heartburn  1  1/23 (4.35%) 
Nausea  1  5/23 (21.74%) 
Vomiting  1  4/23 (17.39%) 
General disorders   
Edema  1  4/23 (17.39%) 
Fatigue  1  10/23 (43.48%) 
Insomnia  1  3/23 (13.04%) 
Pain  1  4/23 (17.39%) 
Infections and infestations   
Infection  1  3/23 (13.04%) 
Metabolism and nutrition disorders   
Hypoalbuminemia  1  2/23 (8.70%) 
ALT  1  4/23 (17.39%) 
AST  1  3/23 (13.04%) 
Bilirubin  1  1/23 (4.35%) 
Hypocalcemia  1  1/23 (4.35%) 
Cholesterol  1  1/23 (4.35%) 
Hyperglycemia  1  5/23 (21.74%) 
Hypokalemia  1  3/23 (13.04%) 
Hypophosphatemia  1  1/23 (4.35%) 
Hyponatremia  1  2/23 (8.70%) 
Musculoskeletal and connective tissue disorders   
Muscle Weakness  1  1/23 (4.35%) 
Nervous system disorders   
Mood Alteration  1  4/23 (17.39%) 
Speech Impairement  1  2/23 (8.70%) 
Ataxia  1  2/23 (8.70%) 
Cognitive Disturbance  1  1/23 (4.35%) 
Confusion  1  2/23 (8.70%) 
Dizziness  1  1/23 (4.35%) 
Headache  1  4/23 (17.39%) 
Neuropathy  1  8/23 (34.78%) 
Seizure  1  4/23 (17.39%) 
Somnolence  1  1/23 (4.35%) 
Respiratory, thoracic and mediastinal disorders   
Pneumonitis  1  1/23 (4.35%) 
Skin and subcutaneous tissue disorders   
Hand-foot Skin Reaction  1  5/23 (21.74%) 
Rash  1  2/23 (8.70%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Erin M. Dunbar, MD
Organization: University of Florida
Phone: (352) 273-9000
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00717197     History of Changes
Other Study ID Numbers: HGG-001
First Submitted: July 15, 2008
First Posted: July 17, 2008
Results First Submitted: February 18, 2013
Results First Posted: March 25, 2013
Last Update Posted: July 2, 2013