A Phase II Trial of Docetaxel and Carboplatin for First Relapsed Platinum-Sensitive Stage III and IV Advanced Ovarian Cancer or Peritoneal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 3
- 主要终点
- Toxicity
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 relapsed stage III or stage IV ovarian epithelial or primary peritoneal cavity cancer.
详细描述
OBJECTIVES:
- Determine the toxicity of docetaxel and carboplatin in patients with platinum-sensitive stage III or IV ovarian epithelial or primary peritoneal cavity cancer in first relapse.
- Determine the response rates (complete and partial response) in patients treated with this regimen.
- Determine relapse rates and event-free survival and overall survival rates in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Patients also receive pegfilgrastim subcutaneously on day 2 . Treatment repeats every 21 days for up to 6 courses.
After completion of study treatment, patients are followed at 3 weeks, every 3 months for 2 years, and then every 6 months thereafter.
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 cavity cancer
- •Stage III or IV disease
- •No borderline tumors
- •Measurable or evaluable disease
- •Measurable disease, defined as evidence of disease by physical examination or radiographic evaluation
- •Evaluable disease, defined as CA 125 ≥ 100 U/mL (confirmed by 2 blood tests performed ≥ 1 week apart)
- •In first relapse
- •Platinum-sensitive disease, defined as initial relapse > 6 months after completion of a platinum-based regimen
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 60-100%
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Platelet count ≥ 100,000/mm^3
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Bilirubin normal
- •Meets 1 of the following criteria:
- •SGOT and/or SGPT ≤ 1.5 times upper limit of normal (ULN) AND alkaline phosphatase (AP) ≤ 2.5 times ULN
- •SGOT and/or SGPT ≤ 5.0 times ULN AND AP normal
- •Creatinine ≤ 2.0 mg/dL
- •Creatinine clearance > 50 mL/min
- •Cardiovascular
- •LVEF ≥ 50%
- •No poorly controlled arrhythmia
- •No unstable coronary artery disease or myocardial infarction within the past year
- •HIV negative
- •No pre-existing peripheral neuropathy > grade 2
- •No history of allergy to study drugs
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •See Disease Characteristics
- •At least 3 weeks since prior chemotherapy and recovered
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •At least 3 weeks since prior radiotherapy and recovered
- •Recovered from recent prior surgery
- •No concurrent myelosuppressive therapy
排除标准
- 未提供
结局指标
主要结局
Toxicity
Response rates (complete and partial response)
Relapse rates
Event-free survival
Overall survival
次要结局
未报告次要终点