NCT00055614已完成1 期
Phase I Study of Oral Topotecan as Consolidation for Patients With Mullerian Origin Tumors (Ovary, Tube, Peritoneum)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
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.
PURPOSE: Phase I trial to study the effectiveness of topotecan in treating patients who have advanced ovarian epithelial, fallopian tube, or primary peritoneal cancer.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose and duration of prolonged topotecan as maintenance in patients with advanced ovarian epithelial, fallopian tube, or primary peritoneal cancer with complete clinical response after platinum-based chemotherapy.
- Determine the safety of this regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive oral topotecan twice daily for 21 days. Treatment repeats every 28 days for up to 6 months in the absence of unacceptable toxicity or disease progression.
Patients who tolerate course 1 may receive an escalated dose of topotecan for subsequent courses. The maximum tolerated dose is defined as the dose tolerated by the majority of the patients.
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 ovarian epithelial, fallopian tube, or primary peritoneal serous cancer
- •Stage IIIB, IIIC, or IV
- •Surgically staged and debulked
- •Complete clinical response after first-line platinum-based chemotherapy (cisplatin or carboplatin) defined by all of the following criteria:
- •No evidence of cancer by history or physical examination
- •CA 125 no greater than 35 units/mL
- •No evidence of residual cancer on CT scan of the abdomen/pelvis and chest x-ray
- •Must have received at least 5 courses of first-line chemotherapy
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Granulocyte count at least 1,200/mm^3
- •Platelet count at least 90,000/mm^3
- •Bilirubin normal
- •ALT and AST less than 1.5 times upper limit of normal (ULN)
- •Alkaline phosphatase less than 1.5 ULN
- •Creatinine clearance at least 60 mL/min
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent immunotherapy
- •Chemotherapy
- •See Disease Characteristics
- •At least 3 weeks since prior first-line chemotherapy
- •At least 3 years since other prior chemotherapy (other than first-line chemotherapy for ovarian, fallopian tube, or primary peritoneal cancer)
- •No other concurrent chemotherapy
- •Endocrine therapy
- •No concurrent hormonal therapy
- •Radiotherapy
- •No prior abdominopelvic radiotherapy
- •No concurrent radiotherapy
- •See Disease Characteristics
- •No concurrent surgery
- •No other concurrent antitumor therapy
排除标准
- 未提供
研究者
研究点 (2)
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