Phase I Trial of the Treatment of Advanced Endometrial Cancer With Concurrent Weekly Paclitaxel and Cisplatin and Whole Abdominal Radiation Therapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Acute toxicity for identification of MTD, using the 21 major categories of the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTEP CTC) v2.0
研究概览
简要总结
This phase I trial is studying the side effects and best dose of combination chemotherapy when given with radiation therapy in treating patients with stage III or stage IV endometrial cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
详细描述
OBJECTIVES:
I. Determine the safety and maximum tolerated doses of paclitaxel and cisplatin when administered with radiotherapy in patients with stage III or IV endometrial cancer.
II. Assess the time to disease progression and overall survival of patients treated with this regimen.
OUTLINE: This is a dose-escalation study of paclitaxel and cisplatin.
Patients receive paclitaxel IV over 1 hour and cisplatin IV on days 1, 8, 15, 22, 29, and 36. Patients also undergo whole abdominal radiotherapy for 5 consecutive days weekly for 6 weeks.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed surgical stage III or IV endometrial cancer
- •Any stage clear or serous papillary endometrial cancer
- •Positive para-aortic lymph nodes allowed
- •Tumor must be surgically reduced to 2 cm or less within 8 weeks of study
- •Must have had hysterectomy and bilateral salpingo-oophorectomy
- •No recurrent disease
- •No metastases to lung or liver parenchyma or inguinal or scalene lymph nodes
- •Performance status - GOG 0-2
- •Absolute neutrophil count greater than 2,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •SGOT no greater than 3 times ULN
- •Creatinine no greater than 1.5 times ULN
- •No other prior or concurrent malignancy in the past 5 years except non-melanoma skin cancer
- •No prior chemotherapy
- •No prior radiotherapy
- •See Disease Characteristics
- •No more than 8 weeks since prior surgery
- •No prior anticancer therapy that would preclude study
排除标准
- 未提供
研究组 & 干预措施
Treatment (paclitaxel, cisplatin, abdominal radiotherapy)
Patients receive paclitaxel IV over 1 hour and cisplatin IV on days 1, 8, 15, 22, 29, and 36. Patients also undergo whole abdominal radiotherapy for 5 consecutive days weekly for 6 weeks.
Cohorts of 3-6 patients receive escalating doses of paclitaxel and cisplatin until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at that dose level.
干预措施: Paclitaxel (Drug)
Treatment (paclitaxel, cisplatin, abdominal radiotherapy)
Patients receive paclitaxel IV over 1 hour and cisplatin IV on days 1, 8, 15, 22, 29, and 36. Patients also undergo whole abdominal radiotherapy for 5 consecutive days weekly for 6 weeks.
Cohorts of 3-6 patients receive escalating doses of paclitaxel and cisplatin until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at that dose level.
干预措施: Cisplatin (Drug)
Treatment (paclitaxel, cisplatin, abdominal radiotherapy)
Patients receive paclitaxel IV over 1 hour and cisplatin IV on days 1, 8, 15, 22, 29, and 36. Patients also undergo whole abdominal radiotherapy for 5 consecutive days weekly for 6 weeks.
Cohorts of 3-6 patients receive escalating doses of paclitaxel and cisplatin until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at that dose level.
干预措施: Radiation Therapy (Radiation)
结局指标
主要结局
Acute toxicity for identification of MTD, using the 21 major categories of the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTEP CTC) v2.0
时间窗: Up to 30 days post-radiotherapy
Calculated using a 90% conditional likelihood-based confidence bound.
Chronic toxicity based on the NCI CTC Radiation Therapy Oncology Group (RTOG)/European Organization for Research and Treatment of Cancer (EORTC) late radiation morbidity scoring scheme
时间窗: Up to 6 months post-radiotherapy
次要结局
- Number of dose level combinations that will have been evaluated prior to MTD establishment(Up to 60 months)
- Site (local/distant) of treatment failure(Up to 5 years)