Oral Topotecan As A Radiosensitizing Agent In Rectal Cancer

This study has been terminated.
Information provided by:
ClinicalTrials.gov Identifier:
First received: September 8, 2005
Last updated: May 21, 2009
Last verified: May 2009
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.

Condition Intervention Phase
Rectal Cancer
Drug: Hycamtin
Phase 1

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • To determine the MTD of oral topotecan in combination with pelvic radiation

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 36
Study Start Date: November 2001

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158886

United States, Florida
GSK Investigational Site
Tampa, Florida, United States, 33612-9497
Sponsors and Collaborators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00158886     History of Changes
Other Study ID Numbers: 104864/517 
Study First Received: September 8, 2005
Last Updated: May 21, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
oral topotecan rectal cancer pelvic radiation

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Rectal Diseases
Radiation-Sensitizing Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on May 04, 2016