Phase 1
N=24
A Study of Xeloda (Capecitabine) Plus Radiation Therapy in Children With Newly Diagnosed Gliomas
Glioma
Bottom Line
View on ClinicalTrials.gov: NCT00532948 ↗Enrolled (actual)
24
Serious AEs
27.3%
Results posted
Mar 2016
Primary outcome: Primary: Maximum Tolerated Dose (MTD) of Capecitabine. — 650 milligrams
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- capecitabine [Xeloda] (Drug)
- Age
- Pediatric, Adult · 3+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) of Capecitabine. |
650 | — |
| PRIMARY Dose Limiting Toxicities (DLTs) |
0; 3; 3 | — |
| PRIMARY Number of Participants With Adverse Events (AE) |
3; 12; 6 | — |
| PRIMARY Number of Participants With Baseline Shift From Normal to Low or High in Hematology Parameters |
2; 1; 4; 0; 0; 0 | — |
| PRIMARY Number of Participants With Baseline Shift From Normal to Low or High in Blood Chemistry Parameters |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Capecitabine and Its Metabolites (5'-Deoxy-5-Fluorocytidine [5'-DFCR], 5'-Deoxy-5-Fluorouridine [5'-DFUR], 5-Fluorouracil [5-FU] and Alpha-fluoro-beta-alanine [FBAL]) |
1440; 3080; 1890; 2100; 5440; 3710 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax) of Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR, 5-FU and FBAL) |
0.58; 0.63; 0.85; 1.33; 0.82; 0.61 | — |
| SECONDARY The Area Under the Plasma Concentration-time Curve From Time of Dosing to the Last Measurable Concentration (AUClast) of Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR, 5-FU and FBAL) |
3370; 5160; 3470; 2890; 9660; 5670 | — |
| SECONDARY Anti Tumor Activity |
— | — |
Summary
This single arm study will assess the maximum tolerated dose, and dose-limiting toxicities, of Xeloda administered concurrently with radiation therapy, in children with newly diagnosed diffuse intrinsic brain stem gliomas and high grade gliomas. Xeloda will be administered twice daily, at a starting dose of 500mg/m2 bid, beginning within 24 hours of the start of radiation therapy. Subsequent dose escalations will be in increments of 30%, using a standard dose escalation schema. Post-radiation therapy with Xeloda will continue after a 2 week break. The anticipated time on study treatment is 3-12 months, and the target sample size will not exceed 30 evaluable patients.
Eligibility Criteria
Inclusion Criteria
- patients >=3 and 16 years) or Lansky (if =50%;
- adequate organ function.
Exclusion Criteria
- previous chemotherapy, radiation therapy, immunotherapy or bone marrow transplant;
- uncontrolled infection;
- known DPD deficiency.
Data sourced from ClinicalTrials.gov (NCT00532948). 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.