NCT00158886

Oral Topotecan As A Radiosensitizing Agent In Rectal Cancer

A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carcinoma, Renal Cell

Interventions

Type	Name	Description
DRUG	Topotecan	Topotecan will be provided as capsules for oral administration and will be administered at least 3 hours before radiation therapy.
RADIATION	Radiation therapy	For radiation therapy, subjects will receive 180 centigray (cGy) per fraction to a total dose of 4500 cGy to the pelvis using a 3 or 4 field technique and high energy photons (\>=6 megavolt \[mv\]).

Timeline

• Start date: 2001-11-08
• Primary completion: 2006-08-11
• Completion: 2006-08-11
• First posted: 2005-09-12
• Last updated: 2017-11-14

Locations

1 site across 1 country: United States