Oral Topotecan As A Radiosensitizing Agent In Rectal Cancer
Status:
Terminated
Trial end date:
2006-08-11
Target enrollment:
Participant gender:
Summary
Patients with rectal cancer who are candidates for pre-operative radiation therapy may be
enrolled in the Phase I, single center study. Patients will have a full blood count,
biochemistry, urinalysis, and ECG for safety evaluation. Sequential cohorts of three patients
will be given increasing doses of oral topotecan and fixed doses of concurrent radiation (45
Gy) over five weeks. The starting dose of oral topotecan is 0.25 mg/m2 to be concomitantly
administered with radiation (45 Gy) x 5 days every week unless the radiation is interrupted
for Holidays/Weekends or toxicity requiring treatment delays occurs. A total of 25 doses are
planned.