A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer
- 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.
- 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
- 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.