Last updated: 11/03/2018 01:14:53

Oral Topotecan As A Radiosensitizing Agent In Rectal Cancer

GSK study ID
104864/517
See study documents
Clinicaltrials.gov ID
NCT00158886
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Terminated (halted prematurely)
Terminated (halted prematurely)
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Phase I study of oral topotecan as a radiosensitizing agent in patients with rectal cancer
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

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

Timeframe: 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.

Timeframe: Up to 24 months

Interventions:
Drug: Topotecan
Radiation: Radiation therapy
Enrollment:
26
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Carcinoma, Renal Cell
Product
topotecan
Collaborators
Not applicable
Study date(s)
November 2001 to August 2006
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Patients with histologically confirmed rectal cancer.
  • Candidates for preoperative radiotherapy.
  • A primary tumor totally excised.
  • Recurrent rectal cancer that failed initial treatment.
Inclusion and exclusion 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.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Tampa, Florida, United States, 33612-9497
Status
Study Complete
Contact us

Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Terminated (halted prematurely)
Actual primary completion date
Not applicable
Actual study completion date
2006-11-08

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Participate in clinical trial
Additional information
Results for study 104864/517 can be found on the GSK Clinical Study Register.
Click here
Access to clinical trial data by researchers
Visit website