Phase 2 N=30 Treatment

Study of Capecitabine to Treat Recurrent High Grade Gliomas

Malignant Glioma

Bottom Line

View on ClinicalTrials.gov: NCT00717197 ↗

Enrolled (actual)

Serious AEs

91.3%

Results posted

Mar 2013

Primary outcome: Primary: Percentage of Participants With Progression-free Survival. — 21.7 percentage of participants with PFS6

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Capecitabine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Florida
Primary completion: Mar 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Progression-free Survival.	21.7	—

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.

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

View full record on ClinicalTrials.gov →

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.