Status:
TERMINATED
Oral Topotecan As A Radiosensitizing Agent In Rectal Cancer
Lead Sponsor:
GlaxoSmithKline
Conditions:
Carcinoma, Renal Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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,...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 8 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 11 2006
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00158886
Start Date
November 8 2001
End Date
August 11 2006
Last Update
November 14 2017
Active Locations (1)
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1
GSK Investigational Site
Tampa, Florida, United States, 33612-9497