NCT00138242已完成2 期
Phase II Trial of Weekly Docetaxel (Taxotere®) and Carboplatin as Initial Chemotherapy for Women With Ovarian Cancer and Similar Malignancies
Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2004年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Reduction rate of myelosuppression
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, 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.
PURPOSE: This phase II trial is studying how well giving docetaxel together with carboplatin works in treating patients with ovarian epithelial, fallopian tube, or peritoneal cavity cancer.
详细描述
OBJECTIVES:
Primary
- Determine whether weekly administration of docetaxel and carboplatin is safer than conventional three-week chemotherapy courses, in terms of reducing the rate of myelosuppression, in patients with stage IC-IV ovarian epithelial, fallopian tube, or peritoneal cavity cancer.
Secondary
- Determine the quality of life of patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
- Determine the efficacy of this regimen, in terms of clinical response rate, time to disease progression, and findings at second-look surgery, in these patients.
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 ovarian epithelial, fallopian tube, or peritoneal cavity cancer
- •Stage IC-IV disease
- •No borderline or low malignant potential tumors of any stage
- •Underwent initial surgical management, including staging, of early stage disease or surgical debulking of advanced stage disease* NOTE: *Patients may delay surgical debulking, if clinically indicated, until after study entry; these patients may receive several courses of neoadjuvant chemotherapy prior to surgical debulking, but before study entry
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Hemoglobin ≥ 8.0 g/dL
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin normal
- •Meets 1 of the following criteria:
- •Alkaline phosphatase (AP) normal AND AST or 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
- •Not specified
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
- •No peripheral neuropathy > grade 1
- •No prior malignancy with a poor prognosis that is at risk of relapse during study participation, as determined by the principal investigator
- •No history of severe hypersensitivity reaction to drugs formulated with polysorbate 80
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No concurrent chemotherapy for another malignancy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •See Disease Characteristics
排除标准
- 未提供
结局指标
主要结局
Reduction rate of myelosuppression
次要结局
- Clinical response rate
- Findings at second look surgery
- Time to disease progression
- Quality of life as assessed by the Functional Assessment of Cancer Therapy -Ovarian (FACT-O) questionnaire
- Toxicity
研究者
研究点 (2)
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