A Phase II Study Of Paclitaxel, Carboplatin And Gemcitabine In Previously Untreated Patients With Epithelial Ovarian Carcinoma FIGO Stage IIB-IV
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 36
- 主要终点
- Evaluation of tolerability and toxicity of the combination therapy with paclitaxel, carboplatin and gemcitabine (P-C-G) in first line treatment of ovarian cancer patients. Evaluation of Drop-out rate due to toxicity
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 combination chemotherapy in treating patients who have stage IC, stage IIB, stage III, or stage IV ovarian epithelial, fallopian tube, or peritoneal cancer that has not been previously treated.
详细描述
OBJECTIVES:
- Determine the tolerability and toxicity of paclitaxel, carboplatin, and gemcitabine in patients with previously untreated stage IC-IV ovarian epithelial, fallopian tube, or peritoneal carcinoma.
- Determine the response rate of patients treated with this regimen.
- Determine the time to progression and overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and gemcitabine IV over 30-60 minutes on days 1 and 8. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed at 3 and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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:
- •Histologically confirmed stage IC-IV ovarian epithelial, fallopian tube, or peritoneal carcinoma
- •No tumors of low-malignant potential (borderline tumors)
- •No symptomatic brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •ECOG 0-2 OR
- •Karnofsky 70-100%
- •Life expectancy:
- •At least 6 months
- •Hematopoietic:
- •WBC at least 3,000/mm^3
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin greater than 10 g/dL
- •Bilirubin no greater than 2 times upper limit of normal
- •Glomerular filtration rate at least 60 mL/min
- •Cardiovascular:
- •No history of congestive heart failure (New York Heart Association class III or IV heart disease) even if medically controlled
- •No myocardial infarction within the past 6 months
- •No history of atrial or ventricular arrhythmias
- •Neurologic:
- •No history of seizure disorder
- •No history of CNS disorder
- •No pre-existing motor or sensory neuropathy or symptoms grade 2 or greater
- •No severe concurrent infection
- •No prior hypersensitivity reaction to products containing Cremophor EL or compounds chemically related to carboplatin, paclitaxel, or gemcitabine
- •No complete bowel obstruction
- •No other concurrent severe medical problems that would preclude study
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent immunotherapy
- •No concurrent WBC transfusions
- •Chemotherapy:
- •No prior chemotherapy
- •No other concurrent chemotherapy
- •Endocrine therapy:
- •No concurrent hormonal therapy except replacement therapy or steroid antiemetics
- •Radiotherapy:
- •No prior radiotherapy
- •No concurrent radiotherapy
- •No more than 6 weeks since prior definitive surgery
排除标准
- 未提供
结局指标
主要结局
Evaluation of tolerability and toxicity of the combination therapy with paclitaxel, carboplatin and gemcitabine (P-C-G) in first line treatment of ovarian cancer patients. Evaluation of Drop-out rate due to toxicity
时间窗: Based on decision level
The decision level is reached, when the lower exact 95% confidence limit of the observed proportion is higher than the upper exact 95% confidence limit of the historical proportion, which corresponds to a power of 0.5 applying a significance level of 0.05
次要结局
未报告次要终点