Oral Topotecan As A Radiosensitizing Agent In Rectal Cancer

Phase 1TerminatedNCT00158886

GlaxoSmithKline26 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinoma, Renal Cell

Interventions

TopotecanDRUG

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

Radiation therapyRADIATION

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 \[mv\]).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

GSK Investigational Site

Tampa, Florida, United States

Outcomes

Primary Outcomes

To determine the MTD of oral topotecan in combination with pelvic radiation

Time frame: Up to 24 months

Secondary Outcomes

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.

Time frame: Up to 24 months

Data from ClinicalTrials.gov

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