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
|Condition or disease||Intervention/treatment||Phase|
|Malignant Glioma||Drug: Capecitabine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study to Determine Therapeutic Response of Oral Capecitabine (Xeloda) in Recurrent High Grade Gliomas (HGGs) by Establishing the Radiographic Response Rate Using Modified Macdonald Criteria|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||May 2013|
Capecitabine (1,000-1,250 mg/m2) taken by mouth twice daily for 14 out of 21 consecutive days until progression or unacceptable toxicity.
1,000-1,250 mg/m2 taken by mouth twice daily for 14 out of 21 consecutive days until progression or unacceptable toxicity.
Other Name: Xeloda
- Percentage of Participants With Progression-free Survival. [ Time Frame: From date of first dose of study drug until month 6. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00717197
|United States, Florida|
|University of Florida|
|Gainesville, Florida, United States, 32610|
|Principal Investigator:||Erin Dunbar, MD||University of Florida|