A Randomized Phase III Study Comparing Gemcitabine Plus Carboplatin Versus Carboplatin Monotherapy in Patients With Advanced Epithelial Ovarian Carcinoma Who Failed First-Line Platinum-Based Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 试验地点
- 148
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. It is not yet known if carboplatin is more effective with or without gemcitabine for ovarian epithelial cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin with or without gemcitabine in treating patients who have advanced ovarian epithelial cancer that has not responded to previous chemotherapy.
详细描述
OBJECTIVES:
- Compare time to progression in patients with advanced ovarian epithelial carcinoma who failed prior first-line platinum-based therapy when treated with carboplatin with or without gemcitabine.
- Compare response rate, duration of response, and survival time of patients treated with these regimens.
- Compare the toxicity of these treatment regimens in these patients.
- Compare quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to progression-free time (6-12 months vs more than 12 months), type of prior first-line therapy, and bidimensionally measurable disease (yes vs no). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive carboplatin IV over 30-60 minutes on day 1 and gemcitabine IV over 30-60 minutes on days 1 and 8.
- Arm II: Patients receive carboplatin IV as in arm I. Treatment in both arms repeats every 3 weeks for up to 6-8 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, before each subsequent chemotherapy course, and at 50 days after study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
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 ovarian epithelial carcinoma not amenable to curative surgery or radiotherapy
- •Evidence of recurrence or progression 6 months after discontinuation of prior first-line platinum-containing regimen
- •No tumor of borderline malignancy
- •Evaluable disease outside previously irradiated area
- •No CNS metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •At least 12 weeks
- •Hematopoietic:
- •Neutrophil count at least 1,500/mm3
- •Platelet count at least 100,000/mm3
- •Not specified
- •Glomerular filtration rate greater than 50 mL/min
- •No concurrent active infection
- •No other primary malignancy except carcinoma in situ of the cervix or adequately treated basal cell skin cancer
- •No other concurrent serious systemic disorder
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •See Disease Characteristics
- •No more than 1 prior platinum-based chemotherapy regimen
- •No prior gemcitabine
- •No other concurrent cytotoxic or antineoplastic treatment
- •Endocrine therapy:
- •At least 3 weeks since prior hormonal therapy
- •Concurrent hormone replacement therapy allowed
- •Concurrent steroid antiemetics allowed
- •Radiotherapy:
- •See Disease Characteristics
- •At least 3 weeks since prior radiotherapy (limited to the small pelvis)
- •Concurrent palliative radiotherapy to nontarget lesions allowed
- •See Disease Characteristics
- •At least 3 weeks since other prior investigational agents
排除标准
- 未提供