A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- To determine the MTD of oral topotecan in combination with pelvic radiation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Topotecan (Drug)
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.
干预措施: Radiation therapy (Radiation)
结局指标
主要结局
To determine the MTD of oral topotecan in combination with pelvic radiation
时间窗: Up to 24 months
次要结局
- 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.(Up to 24 months)