A Pharmacokinetic Study of Oral Cyclophosphamide and Topotecan in Children With Recurrent Solid Tumors
Status:
Completed
Trial end date:
2007-02-01
Target enrollment:
Participant gender:
Summary
The purposes of this study include:
- Determination of the change in clearance of topotecan and topotecan lactone between day
1 and day 14 for patients receiving treatment with p.o. topotecan and p.o.
cyclophosphamide x 14 days.
- Determination of the correlation between the activity of CYP3A4, as measured by the 14C-
Erythromycin Breath Test (ERMBT), and topotecan/topotecan lactone clearance for patients
receiving treatment with p.o. topotecan and p.o. cyclophosphamide x 14 days.
- Determination of the response rate to oral cyclophosphamide and oral topotecan in
recurrent and/or refractory pediatric solid tumors.
- Obtain additional safety data for the chemotherapy regimen, p.o. topotecan and p.o.
cyclophosphamide x 14 days.
- Report the frequency of severe toxicities associated with the level of CYP3A4 activity,
as measured by the ERMBT, for patients receiving treatment with p.o. topotecan and p.o.
cyclophosphamide x 14 days.