NCT00001427已完成2 期
A Phase II Trial of 72-Hour Continuous IV Infusion of 9-Aminocamptothecin With G-CSF Support in Patients With Advanced Ovarian Cancer Previously Treated With Paclitaxel and Cisplatin
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
The objectives of this study are to determine the response rate to 9-AC in patients with advanced ovarian cancer who have recurrent disease after paclitaxel- and cisplatin-based chemotherapy regimens.
详细描述
This is a Phase II study of 9-aminocamptothecin (9-AC), administered as an intravenous continuous infusion over 72 hours with G-CSF support for patients with advanced refractory ovarian cancer. The objectives of the present study are to determine the response rate to 9-AC in patients with advanced ovarian cancer who have recurrent disease after paclitaxel- and cisplatin-based chemotherapy regimens.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven, advanced epithelial ovarian cancer.
- •Histologic confirmation by Pathology Department, NIH, required.
- •Recurrent disease after paclitaxel and either cisplatin or carboplatin. Combination platinum/paclitaxel acceptable.
- •Bidimensionally measurable disease on physical exam, radiographs, or peritoneoscopy. Repeat peritoneoscopy after 8 courses of therapy required if documentation of disease was solely by peritoneoscopy.
- •Laparotomy not required.
- •No CNS metastasis.
- •No borderline or mixed histology.
- •PRIOR/CONCURRENT THERAPY:
- •See Disease Characteristics.
- •More than 4 weeks since any prior therapy and recovered.
- •No prior camptothecin analogue-based chemotherapy.
- •No prior radiotherapy except intraperitoneal 32-P.
- •PATIENT CHARACTERISTICS:
- •Age: 18 and over.
- •Performance status: ECOG 0-
- •Hematopoietic:
- •WBC greater than 3,
- •AGC greater than 1,
- •Platelets at least 100,
- •Hemoglobin greater than 9 g/dL OR;
- •Hematocrit greater than 27 g/dL.
- •Bilirubin no greater than 1.5 mg/dL.
- •Serum transaminases no greater than 2 times normal.
- •24-hour creatinine clearance greater than 45 mL/min (documented by NCI investigator or primary care physician).
- •Cardiovascular:
- •No myocardial infarction within 12 months.
- •No active congestive heart failure.
- •No heart block.
- •No arrhythmia requiring medication.
- •No active uncontrolled infection.
- •No known HIV positivity.
- •No second malignancy currently under treatment except: Local basal cell carcinoma of the skin, Cervical carcinoma in situ, Other malignancies (e.g., stage I breast cancer) eligible at the discretion of the principal or associate investigators.
- •No pregnant women.
排除标准
- 未提供
研究者
研究点 (1)
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