NCT00354601终止2 期
A Phase II Study of Weekly Docetaxel and Capecitabine for Persistent or Recurrent Platinum Resistant Epithelial Carcinoma of the Ovary, Fallopian Tube or Peritoneum
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Objective Tumor Response
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving docetaxel together with carboplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel together with capecitabine works in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or peritoneal cavity cancer.
详细描述
OBJECTIVES:
Primary
- Determine the response rate in patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or peritoneal cavity cancer treated with docetaxel and capecitabine.
Secondary
- Determine the time to progression in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine the quality of life during treatment of these patients.
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 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of 1 of the following:
- •Ovarian epithelial adenocarcinoma
- •Fallopian tube cancer
- •Peritoneal cavity cancer
- •Recurrent or persistent disease after no more than 2 prior treatment regimens (1 regimen for primary disease and/or 1 regimen for recurrent disease)
- •Platinum-resistant disease, defined as 1 of the following:
- •Treatment-free interval < 6 months after platinum-based therapy
- •Disease progression during platinum-based therapy
- •Measurable disease by physical exam, chest x-ray, CT scan, or MRI
- •No brain metastases
- •PATIENT CHARACTERISTICS:
- •Gynecologic Oncology Group performance status 0-2
- •Life expectancy > 6 months
- •Absolute neutrophil count ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Hemoglobin ≥ 8 g/dL
- •Creatinine clearance ≥ 50 mL/min
- •Bilirubin normal
- •AST or ALT and alkaline phosphatase (AP) meeting 1 of the following criteria:
- •AST or ALT ≤ 5 times upper limit of normal (ULN) AND AP normal
- •AST or ALT ≤ 1.5 times ULN AND AP ≤ 2.5 times ULN
- •AST or ALT normal AND AP ≤ 5 times ULN
- •No peripheral neuropathy > grade 2
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 6 months after completion of study treatment
- •No other concurrent malignancy except for curatively treated nonmelanoma skin cancer
- •No prior invasive malignancy < 5 years after curative therapy
- •No serious uncontrolled medical or psychiatric illness that would preclude study participation or limit survival to < 6 months
- •No history of severe hypersensitivity reaction to drugs formulated with polysorbate 80 or to fluoropyrimidine therapy or fluorouracil
- •No inability to tolerate oral medication due to bowel obstruction, lack of physical integrity of the upper gastrointestinal tract, inability to swallow, or malabsorption syndrome
- •No serious concurrent infections
- •No clinically significant cardiac disease not well controlled with medication, including any of the following:
- •Congestive heart failure
- •Symptomatic coronary artery disease
- •Symptomatic cardiac arrhythmias
- •Myocardial infarction within the past 12 months
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior docetaxel or capecitabine or other fluoropyrimidine therapy
- •Recovered from prior therapy
- •At least 2 weeks since prior major surgery
- •At least 4 weeks since prior chemotherapy, hormone therapy, or radiotherapy
- •No other concurrent chemotherapeutic agents, biological therapy, radiotherapy, or other investigational agents
排除标准
- 未提供
研究组 & 干预措施
Weekly Docetaxel and Capecitabine
Experimental
Weekly Docetaxel and Capecitabine
干预措施: capecitabine (Drug)
Weekly Docetaxel and Capecitabine
Experimental
Weekly Docetaxel and Capecitabine
干预措施: docetaxel (Drug)
结局指标
主要结局
Objective Tumor Response
时间窗: 8 weeks
The number of partial and complete responders among all evaluable patients as defined using Response Evaluation Criteria in Solid Tumors guidelines
次要结局
- Number of Participants With Grade 3 or Higher Toxicity(Days 1, 8, 15, 21 of each course and treatment end (28 days after last dose or start of new therapy))
- Quality of Life(Pre-entry, day 1, treatment end)
- Time to Progression(Evaluated every 8 weeks during treatment)
研究者
研究点 (1)
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