drugset / Trial / NCT00215956
A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Carcinoma
Phase 1
Completed
31 enrolled
H. Lee Moffitt Cancer Center and Research Institute
GlaxoSmithKline · collab
NaSingle-groupOpen-labelTreatment
Summary
This is an open-label, single center, phase I study designed to determine the MTD or oral topotecan as a radiosensitizing agent in the treatment of rectal cancer patients. Sequential cohorts of three patients will be given increasing doses of oral topotecan and fixed doses of concurrent radiation (45GY) over five weeks.
Timeline
- Start
- 2001-11
- Primary completion
- 2008-01
- Completion
- 2008-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Topotecan | Small molecule | 0.25 mg/m2 | Oral |