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
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Condition or disease | Intervention/treatment | Phase |
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Malignant Glioma | Drug: Capecitabine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Capecitabine
Capecitabine (1,000-1,250 mg/m2) taken by mouth twice daily for 14 out of 21 consecutive days until progression or unacceptable toxicity.
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Drug: Capecitabine
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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histological confirmation of high grade glioma (WHO grade III or IV: anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed glioma, and glioblastoma multiforme)
- Male or female 18 years of age or older
- Negative pregnancy test (if of childbearing potential)
- Any number of previous recurrences will be allowed
- Karnofsky Performance Status > 60
- Hematocrit > 30,000
- White blood cell count > 1,500
- Platelet > 100,000
- Absolute Neutrophil Count > 1,000
- Bilirubin < 1.5 x upper limits of normal
- Transaminases (ALT and AST) < 1.5 x upper limits of normal
- Creatinine < 1.5 x upper limits of normal
- Adequate medical health to participate in this study
- Adequate documentation of menopause (natural/surgical) or patient commitment to routine use of reliable birth control (barrier/hormonal)
- Ability to read and understand the informed consent document
- Ability and willingness to follow all requirements of the study including following all directions, taking medication as prescribed and completing all diaries and forms
Exclusion Criteria:
- Karnofsky Performance Status < 60
- Hematocrit < 30,000
- White blood cell count < 1,500
- Platelet < 100,000
- Absolute Neutrophil Count < 1,000
- Bilirubin >1.5 x upper limits of normal
- Transaminases (ALT and AST) > 1.5 x upper limits of normal
- Creatinine > 1.5 x upper limits of normal
- Inability to undergo gadolinium-contrasted MRIs, including severe claustrophobia or insufficient allergy prophylaxis

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 |
Responsible Party: | University of Florida |
ClinicalTrials.gov Identifier: | NCT00717197 |
Other Study ID Numbers: |
HGG-001 |
First Posted: | July 17, 2008 Key Record Dates |
Results First Posted: | March 25, 2013 |
Last Update Posted: | July 2, 2013 |
Last Verified: | June 2013 |
HGG anaplastic astrocytoma anaplastic oligodendroglioma anaplastic mixed glioma |
glioblastoma multiforme GBM Xeloda capecitabine |
Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Capecitabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |