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Oral Topotecan As A Radiosensitizing Agent In Rectal Cancer

NCT00158886 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2017-11-14

No results posted yet for this study

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

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 \[mv\]).

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-11-08
Primary Completion
2006-08-11
Completion
2006-08-11

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00158886 on ClinicalTrials.gov