NCT00004081已完成2 期
A Phase II Trial of Weekly, Low-Dose Docetaxel (Taxotere) in Patients With Platinum-Resistant Epithelial Ovarian or Primary Peritoneal Serous Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
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.
PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating women who have ovarian epithelial cancer or primary peritoneal cancer that has not responded to previous treatment.
详细描述
OBJECTIVES:
- Determine the activity of docetaxel in women with platinum resistant, refractory ovarian epithelial or primary peritoneal serous cancer.
OUTLINE: Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive a minimum of 6 courses of therapy, including 2 courses beyond CR.
PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 2 years.
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 or primary peritoneal serous cancer that is resistant to platinum therapy
- •Platinum resistance as defined by one of the following:
- •Relapse within 6 months of platinum based chemotherapy
- •Residual disease after completion of platinum based chemotherapy
- •Disease progression while receiving platinum based chemotherapy
- •Marker only relapse (CA-125 elevation) and measurable disease
- •Bidimensionally measurable disease on exam or CT scan
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Greater than 2 months
- •Hematopoietic:
- •WBC at least 3,000/mm3
- •Absolute neutrophil count at least 1,500/mm3
- •Platelet count at least 100,000/mm3
- •Bilirubin no greater than upper limit of normal (ULN)
- •SGPT or SGOT no greater than 1.5 times ULN
- •Alkaline phosphatase no greater than 2.5 times ULN
- •Creatinine no greater than 1.5 mg/dL
- •Cardiovascular:
- •Acceptable cardiac exam
- •No active cardiac ischemia
- •Acceptable pulmonary exam
- •No active pulmonary infection or compromise
- •Not pregnant or nursing
- •No severe peripheral neuropathy (grade 2 or greater)
- •No other significant psychiatric or medical conditions that would interfere with compliance
- •No other malignancies within the past 3 years, except:
- •Limited basal or squamous cell skin cancer
- •Carcinoma in situ of the cervix
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior cytokine therapy
- •Chemotherapy:
- •See Disease Characteristics
- •At least 3 weeks since prior chemotherapy for ovarian epithelial or peritoneal serous cancer
- •Prior paclitaxel allowed
- •No prior docetaxel
- •At least 3 years since prior chemotherapy for other disease
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •No prior pelvic radiotherapy
- •Not specified
排除标准
- 未提供
研究者
Stephen Cannistra, MD
Investigator
Beth Israel Deaconess Medical Center
研究点 (2)
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