A PHASE I STUDY OF PELVIC RADIATION THERAPY WITH CONCOMITANT WEEKLY CISPLATIN AND TOPOTECAN CHEMOTHERAPY IN PATIENTS WITH CERVICAL CARCINOMA WITHOUT EXTRA-PELVIC METASTASIS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 10
- 主要终点
- Incidence of patients with chronic toxicity assessed by Common Toxicity Criteria Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer (CTC RTOG/EORTC)
研究概览
简要总结
This phase I trial is studying the side effects and best way to give radiation therapy when given together with topotecan and cisplatin in treating patients with locally advanced cervical cancer. This trial is also studying the best dose of topotecan when given in this regimen. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as topotecan and cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
详细描述
PRIMARY OBJECTIVES:
I. Determine the safety and tolerability of pelvic radiotherapy, cisplatin, and topotecan in patients with locally advanced cervical cancer.
II. Determine the maximum tolerated dose (MTD) of topotecan when administered in this regimen in this patient population.
SECONDARY OBJECTIVES:
I. Determine the site of recurrence (local vs distant) in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed primary invasive carcinoma of the uterine cervix
- •Stages IB2, II, IIIB, and IVA disease
- •Any cell type
- •No known metastasis to scalene nodes or organs outside the radiation field
- •No known intraperitoneal metastases
- •No evidence of extrapelvic disease based on negative CT or PET scan
- •Must enroll within 8 weeks of diagnosis
- •Performance status - GOG 0-2
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •SGOT ≤ 2.5 times ULN
- •Alkaline phosphatase ≤ 2.5 times ULN
- •Creatinine normal
- •Creatinine clearance > 50 mL/min
- •Prior ureteral obstruction allowed provided stent or nephrostomy tube has been placed
- •No renal abnormalities, such as pelvic kidney, horseshoe kidney, or prior renal transplantation that would require modification of radiation fields
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other malignancy within the past 5 years except nonmelanoma skin cancer
- •No septicemia or severe infection
- •No other medical or psychiatric condition that would preclude study compliance
- •No prior chemotherapy for any prior malignancy
- •No prior cytotoxic chemotherapy for this malignancy
- •No prior radiotherapy for any prior malignancy
- •No prior pelvic or abdominal radiotherapy for this malignancy
- •No prior therapy for this malignancy
排除标准
- 未提供
研究组 & 干预措施
Treatment (topotecan hydrochloride, radiation, cisplatin)
Patients undergo radiotherapy 5 days a week for 6 weeks. Patients receive cisplatin IV and topotecan IV over 30 minutes once weekly for a total of 6 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: Topotecan Hydrochloride Liposomes (Drug)
Treatment (topotecan hydrochloride, radiation, cisplatin)
Patients undergo radiotherapy 5 days a week for 6 weeks. Patients receive cisplatin IV and topotecan IV over 30 minutes once weekly for a total of 6 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: 3-Dimensional Conformal Radiation Therapy (Radiation)
Treatment (topotecan hydrochloride, radiation, cisplatin)
Patients undergo radiotherapy 5 days a week for 6 weeks. Patients receive cisplatin IV and topotecan IV over 30 minutes once weekly for a total of 6 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: Cisplatin (Drug)
结局指标
主要结局
Incidence of patients with chronic toxicity assessed by Common Toxicity Criteria Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer (CTC RTOG/EORTC)
时间窗: Up to 5 years
Incidence of patients with acute toxicity assessed by Common Terminology Criteria for Adverse Events version 3.0
时间窗: Up to 30 days after completion of radiation therapy
次要结局
- Site of treatment failure(Up to 5 years)