A Phase II Trial of Induction Carboplatin and Docetaxel Followed by Radiotherapy Then Consolidation Chemotherapy With Carboplatin and Docetaxel in Stage III, IV and Recurrent Endometrial Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Percent of Patients Estimated to be Progression-Free and Alive
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as carboplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving carboplatin and docetaxel followed by radiation therapy works in treating patients with stage III, stage IV, or recurrent endometrial cancer.
详细描述
OBJECTIVES:
Primary
- Determine the time to progression in patients with stage III or IV or recurrent endometrial cancer treated with induction chemotherapy comprising carboplatin and docetaxel followed by radiotherapy and consolidation chemotherapy comprising carboplatin and docetaxel.
Secondary
- Determine the toxic effects of this regimen in these patients.
- Determine the overall survival of 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
- 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 endometrial cancer
- •Advanced or recurrent disease
- •Stage IIIB or IIIC disease
- •Stage IIIA disease allowed provided there is serosal involvement or direct extension or metastasis to the adnexa
- •No stage IIIA confirmed by only positive peritoneal washings
- •Stage IVA or IVB disease
- •Failed local therapy or considered incurable with local therapy
- •Measurable or evaluable disease
- •Not required for newly diagnosed stage III or IV disease with no remaining disease after surgery
- •Performance status Gynecology Oncology Group (GOG) 0-1
- •Life expectancy at least 12 weeks
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 10 g/dL
- •Meets 1 of the following criteria:
- •Alkaline phosphatase (AP) normal AND aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 5 times upper limit of normal (ULN)
- •AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
- •AP ≤ 5 times ULN AND AST or ALT normal
- •Bilirubin normal
- •No acute hepatitis
- •Creatinine ≤ 1.5 mg/dL
排除标准
- •Known hypersensitivity to docetaxel or polysorbate 80
- •Severe infection
- •Septicemia
- •Pregnant or nursing
- •Positive pregnancy test
- •Fertile patients must use effective nonhormonal contraception during and for at least 3 months after study treatment
- •Peripheral neuropathy ≥ grade 2
- •Severe gastrointestinal bleeding requiring a blood transfusion or hospitalization
- •Other malignancy within the past 5 years except nonmetastatic, nonmelanoma skin cancer or carcinoma in situ of the cervix
- •Prior chemotherapy
- •Prior radiotherapy
研究组 & 干预措施
Patients with Endometrial Cancer
Patients with advanced or current endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (Weekly, 5 days/week over 6-7 weeks, tailored 4500 cGy) and followed by 3 courses of consolidation docetaxel (75 mg/m^2 on Day 1 of each course) /carboplatin (Dose = Area-under-the-curve 6 on Day 1 every 3 weeks for 3 cycles).
干预措施: carboplatin (Drug)
Patients with Endometrial Cancer
Patients with advanced or current endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (Weekly, 5 days/week over 6-7 weeks, tailored 4500 cGy) and followed by 3 courses of consolidation docetaxel (75 mg/m^2 on Day 1 of each course) /carboplatin (Dose = Area-under-the-curve 6 on Day 1 every 3 weeks for 3 cycles).
干预措施: docetaxel (Drug)
Patients with Endometrial Cancer
Patients with advanced or current endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (Weekly, 5 days/week over 6-7 weeks, tailored 4500 cGy) and followed by 3 courses of consolidation docetaxel (75 mg/m^2 on Day 1 of each course) /carboplatin (Dose = Area-under-the-curve 6 on Day 1 every 3 weeks for 3 cycles).
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Percent of Patients Estimated to be Progression-Free and Alive
时间窗: 1 Year, 2 Years, 3 Years
This estimate was determined by using a statistical method of analysis (Kaplan-Meier).
次要结局
- Percent of Patients Estimated to be Alive(1 Year, 2 Years, 3 Years)