Oral Topotecan As A Radiosensitizing Agent In Rectal Cancer

NCT ID: NCT00158886

Last Updated: 2017-11-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-11-08
• Study Completion Date: 2006-08-11

Brief 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

Keywords

oral topotecan rectal cancer pelvic radiation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Subjects with rectal cancer

Subjects will be administered topotecan along with concomitant radiation for five days per week for five weeks. Topotecan doses will start at 0.25 milligrams per square meter (mg/m˄2) and will be escalated 0.15 mg/m˄2 for subsequent cohorts. To advance to the next dose level of topotecan, at least two subjects will have to complete therapy with oral topotecan without experiencing grade 3 or 4 toxicity for three weeks after the oral topotecan treatment.

Group Type: EXPERIMENTAL

Topotecan

Intervention Type: DRUG

Topotecan will be provided as capsules for oral administration and will be administered at least 3 hours before radiation therapy.

Radiation therapy

Intervention Type: RADIATION

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 \[mv\]).

Interventions

Topotecan

Topotecan will be provided as capsules for oral administration and will be administered at least 3 hours before radiation therapy.

Intervention Type: DRUG

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 \[mv\]).

Intervention Type: RADIATION

Other Intervention Names

Hycamtin

Eligibility Criteria

Inclusion Criteria

• Patients with histologically confirmed rectal cancer.
• Candidates for preoperative radiotherapy.
• Primary tumor at least 3cm and clinical stage of T2, T3, or T4 and any N according to the Astler-Coller modification of the Dukes staging system.
• Eastern Cooperative Oncology Group (ECOG) performance status less than 2.
• Diagnosis of rectal cancer should be no more than 90 days from start of therapy.
• Evaluation at the H. Lee Moffitt Cancer Center.
• Recovery from prior surgery and life expectancy at least 3 months.

Exclusion Criteria

• A primary tumor totally excised.
• Recurrent rectal cancer that failed initial treatment.
• Exposure to topotecan, infection, immunodeficiencies, conditions of the gastrointestinal (GI) tract which would affect absorption, medication that maintains motility/gastric emptying.
• Any concomitant malignancy within the last five years.
• Severe medical problems unrelated to the malignancy which would limit compliance with the study.
• Patients of child bearing potential.
• Not practicing adequate contraception.
• Patients who are pregnant or lactating.
• Use of an investigational drug within 30 days or 5 half-lives of the first dose.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Tampa, Florida, United States

Countries

United States

Other Identifiers

104864/517

Identifier Type: -

Identifier Source: org_study_id