Oral Topotecan As A Radiosensitizing Agent In Rectal Cancer
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer|
- To determine the MTD of oral topotecan in combination with pelvic radiation
- To evaluate the toxicity and potential efficacy of oral topotecan and concurrent pelvic radiation for the treatment of rectal cancer. To determine pathologic response to treatment and assessment of sphincter preservation.
|Study Start Date:||November 2001|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00158886
|United States, Florida|
|GSK Investigational Site|
|Tampa, Florida, United States, 33612-9497|
|Study Director:||GSK Clinical Trials, MD||GlaxoSmithKline|