A Study of Capecitabine [Xeloda] and Concomitant Radiation Therapy in Children and Adolescent Patients With Newly Diagnosed Brainstem Glioma
| Status: | Archived |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | February 2010 |
| End Date: | September 2015 |
An Open-label, Phase II Study Evaluating the Safety and Efficacy of the Addition of Capecitabine (Xeloda®) to Radiation Therapy Compared to Historical Control, in Children With Newly-diagnosed Non-disseminated Intrinsic Diffuse Brain Stem Gliomas.
This open-label study will evaluate the progression-free survival, safety and
pharmacokinetics of capecitabine [Xeloda] rapidly disintegrating tablets and concomitant
radiation therapy in children and adolescent patients with newly diagnosed brainstem glioma.
Xeloda will be administered 650 mg/m2 orally twice daily during radiation phase (courses
1-3) followed by a two-weeks break and Xeloda will be administered 1250 mg/m2 during post
radiation (courses 4-6). During each course, Xeloda will be administered for 14 consecutive
days followed by a 7-days rest period. Dose can be adjusted according to toxicity and body
surface area. The anticipated time on study drug is 18 weeks.
We found this trial at
8
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials