NCT00005051已完成2 期
Phase II Study of First-Line Therapy of Ovarian Cancer With Sequential Regimens: Cisplatin-Prolonged Oral Topotecan (C-PORT) Followed by Paclitaxel/Carboplatin (PC)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 10
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 advanced ovarian epithelial cancer.
详细描述
OBJECTIVES:
- Determine the toxicity and tolerance of sequential therapy with prolonged
- Determine the response rate and time to progression in this patient
- Determine the relative pharmacokinetics of IV and prolonged oral administration of topotecan in the same patients and compare the pharmacodynamics of topo-1 inhibition when given by IV or oral route.
OUTLINE:
- Regimen A: Patients receive cisplatin IV over 60-90 minutes on day 1 of each course. Topotecan IV is administered continuously on days 1-14 of course 1. Oral topotecan is administered twice daily on days 1-14 for courses 2, 3, and 4. Treatment repeats every 28 days for 4 courses.
- Regimen B: After completion of regimen A, patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses.
PROJECTED ACCRUAL: A total of 30 patients (15 per arm) will be accrued for this study.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed advanced ovarian epithelial carcinoma, regardless of quantity of disease post-surgery
- •Stage IC, II, III, or IV
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •SGOT no greater than 3 times upper limit of normal
- •Bilirubin no greater than 2.0 mg/dL
- •No clinically significant hepatic disorder
- •Creatinine no greater than 1.5 mg/dL OR
- •Creatinine clearance greater than 60 mL/min
- •No clinically significant renal disorder
- •Cardiovascular:
- •No clinically significant cardiovascular condition
- •Normal GI function allowing reliable administration of oral medication
- •No active infection requiring systemic medical therapy within past week
- •No other clinically significant medical condition (e.g., endocrine/metabolic or autoimmune disorder)
- •No other prior malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- •No dementia or altered mental status that would preclude consent
- •Not pregnant
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No prior chemotherapy for ovarian epithelial carcinoma
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •No prior radiotherapy for ovarian epithelial carcinoma
- •See Disease Characteristics
排除标准
- 未提供
研究者
研究点 (10)
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