Phase 2
Completed N=30
Study of Capecitabine to Treat Recurrent High Grade Gliomas
Source: ClinicalTrials.gov NCT00717197 ↗Enrolled (actual)
30
Serious AEs
91.3%
Results posted
Mar 2013
Primary outcomePrimary: Percentage of Participants With Progression-free Survival. — 21.7 percentage of participants with PFS6
Summary
The purpose of this study is to determine if capecitabine is effective in the treatment of high grade gliomas that have returned after completing treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Progression-free Survival. |
21.7 | — |
Eligibility Criteria
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
- Inability to undergo gadolinium-contrasted MRIs, including severe claustrophobia or insufficient allergy prophylaxis
Data sourced from ClinicalTrials.gov (NCT00717197). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.