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
Other
Other
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
    Primary completion date:
    Not applicable
    Observational study model:
    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
    Other
    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