NCT00003560Unknown2 期
A Phase II Study of Docetaxel and Carboplatin for Suboptimally Debulked Stage III or Stage IV Ovarian and Fallopian Tube Carcinoma
Herbert Irving Comprehensive Cancer Center1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 1998年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and carboplatin in treating patients who have stage III or stage IV ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
详细描述
OBJECTIVES:
- Evaluate the response rate, duration of response, and progression-free and overall survival of previously untreated patients with suboptimally debulked stage III or stage IV ovarian carcinoma, fallopian tube carcinoma, papillary serous cancer of the uterus, or primary peritoneal carcinoma treated with docetaxel and carboplatin.
- Evaluate the feasibility and toxicity of this regimen in these patients.
- Evaluate the effect of this regimen on quality of life of these patients.
OUTLINE: This is an open-label study.
Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed prior to therapy and then after every 3 courses of chemotherapy.
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed previously untreated ovarian cancer, fallopian tube carcinoma, papillary serous cancer of the uterus, or primary peritoneal carcinoma
- •Suboptimally debulked stage III or suboptimally or optimally debulked stage IV
- •Measurable or evaluable disease
- •CNS lesions, lytic bone lesions, and radiated lesions (unless there is documented progression after radiotherapy) are not considered measurable
- •CA 125 levels above 49 units/mL in the absence of cirrhosis or nonmalignant gross ascites are considered evaluable
- •Ineligible for other high-priority national or institutional study
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •More than 2 months
- •Hematopoietic:
- •WBC greater than 3,000/mm3
- •Platelet count greater than 100,000/mm3
- •Bilirubin less than 1.5 times upper limit of normal (ULN)
- •SGOT and/or SGPT less than 2.5 times ULN OR
- •SGOT and/or SGPT no greater than 2.5 times ULN if alkaline phosphatase no greater than ULN OR
- •Alkaline phosphatase no greater than 4 times ULN if SGOT and/or SGPT no greater than ULN
- •No SGOT and/or SGPT greater than 1.5 times ULN with alkaline phosphatase greater than 2.5 times ULN
- •Alkaline phosphatase less than 350 U/L
- •BUN less than 1.5 times normal
- •Creatinine less than 1.5 times ULN
- •No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or skin cancer
- •No other serious medical or psychiatric illness
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No prior chemotherapy
- •No other concurrent chemotherapy
- •Endocrine therapy:
- •No concurrent hormone therapy
- •Radiotherapy:
- •See Disease Characteristics
- •No prior radiotherapy
- •See Disease Characteristics
排除标准
- 未提供
研究者
研究点 (1)
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