Oral Topotecan As A Radiosensitizing Agent In Rectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00158886
Recruitment Status : Terminated
First Posted : September 12, 2005
Last Update Posted : November 14, 2017
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Renal Cell Drug: Topotecan Radiation: Radiation therapy Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer
Actual Study Start Date : November 8, 2001
Primary Completion Date : August 11, 2006
Study Completion Date : August 11, 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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.
Drug: Topotecan
Topotecan will be provided as capsules for oral administration and will be administered at least 3 hours before radiation therapy.
Other Name: Hycamtin
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]).

Primary Outcome Measures :
  1. To determine the MTD of oral topotecan in combination with pelvic radiation [ Time Frame: Up to 24 months ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00158886

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

Additional Information:
Responsible Party: GlaxoSmithKline Identifier: NCT00158886     History of Changes
Other Study ID Numbers: 104864/517
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017

Keywords provided by GlaxoSmithKline:
oral topotecan rectal cancer pelvic radiation

Additional relevant MeSH terms:
Rectal Neoplasms
Carcinoma, Renal Cell
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents