NCT00075543Unknown1 期
Phase I-II Study Of Docetaxel And Oxaliplatine In Patients With Stage III-IV Ovarian Epithelial Cancer
GERCOR - Multidisciplinary Oncology Cooperative Group10 个研究点 分布在 1 个国家开始时间: 2003年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 试验地点
- 10
- 主要终点
- Toxicity
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel and oxaliplatin and to see how well they work in treating patients with stage III or stage IV ovarian epithelial cancer.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of docetaxel and oxaliplatin in patients with stage III or IV ovarian epithelial cancer.
- Determine the toxicity of this regimen in these patients.
Secondary
- Determine the tolerance profile of patients treated with this regimen.
- Determine a recommended phase III dose of this regimen in these patients.
- Determine the efficacy of this regimen, in terms of objective response rate and radiological and biological response rate (CA 125), in these patients.
- Determine the complete pathological response in patients treated with this regimen as first-line therapy.
- Determine the duration of the objective response in patients treated with this regimen.
- Determine the time to progression in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed ovarian epithelial cancer
- •Stage III or IV disease
- •Metastatic peritoneal, lymphatic, or visceral disease
- •Measurable or evaluable disease
- •Previously untreated disease OR relapsed disease more than 6 months after the completion of a platinum-containing chemotherapy regimen
- •No symptomatic brain metastases
- •PATIENT CHARACTERISTICS:
- •Performance status
- •WHO 0-2 (0 in patients 70 to 75 years of age)
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.25 times upper limit of normal (ULN)
- •AST and ALT no greater than 3 times ULN
- •Alkaline phosphatase less than 2.5 times ULN
- •Creatinine no greater than 1.4 mg/dL
- •No serious uncontrolled infection
- •No intolerance to polysorbate 80
- •No peripheral neuropathy greater than grade 1
- •No neurological or mental disease that would preclude study participation
- •No other prior malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •See Disease Characteristics
- •More than 4 weeks since prior chemotherapy
- •No more than 1 prior chemotherapy regimen
- •No prior oxaliplatin or docetaxel
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •More than 4 weeks since prior radiotherapy
- •Not specified
- •More than 28 days since prior participation in another clinical study
- •No other concurrent anticancer treatment
排除标准
- 未提供
结局指标
主要结局
Toxicity
Maximum tolerated dose of docetaxel and oxaliplatin
次要结局
- Tolerance profile
- Recommended phase III dose
- Efficacy
- Duration of the objective response
- Complete pathological response
- Time to progression
研究者
研究点 (10)
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