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Oral Topotecan As A Radiosensitizing Agent In Rectal Cancer

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00158886
First Posted: September 12, 2005
Last Update Posted: November 14, 2017
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.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
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
Carcinoma, Renal Cell Drug: Topotecan Radiation: Radiation therapy Phase 1

Study Type: Interventional
Study Design: 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

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 [ Time Frame: Up to 24 months ]

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. [ Time Frame: Up to 24 months ]

Enrollment: 26
Actual Study Start Date: November 8, 2001
Study Completion Date: August 11, 2006
Primary Completion Date: August 11, 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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]).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00158886


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

Additional Information:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00158886     History of Changes
Other Study ID Numbers: 104864/517
First Submitted: September 8, 2005
First Posted: September 12, 2005
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
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases
Topotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents