NCT00006267撤回2 期
A Phase II Evaluation Of 9-Nitro-Camptothecin In The Third-Line Treatment Of Recurrent Ovarian Or Primary Peritoneal Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
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 II trial to study the effectiveness of nitrocamptothecin in treating patients who have recurrent or metastatic ovarian epithelial or primary peritoneal cancer.
详细描述
OBJECTIVES:
- Determine the antitumor activity of nitrocamptothecin in patients with recurrent or metastatic ovarian epithelial or primary peritoneal cancer.
- Determine the nature and degree of toxicity of this regimen in these patients.
OUTLINE: Patients receive oral nitrocamptothecin on days 1-5. Treatment continues every 7 days in the absence of disease progression or unacceptable toxicity.
Patients are followed at 2 weeks, then every 3 months for 2 years, and then every 6 months for 3 years.
PROJECTED ACCRUAL: Approximately 19-51 patients will be accrued for this study within 22 months.
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 confirmed recurrent or metastatic ovarian epithelial or primary peritoneal cancer
- •Measurable disease
- •Ascites and pleural effusions are not considered measurable
- •Sonography allowed if bidimensionally measurable
- •Must not be eligible for higher priority GOG protocol
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 3,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Granulocyte count at least 1,500/mm^3
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •SGOT and alkaline phosphatase no greater than 3 times ULN
- •Creatinine no greater than 2.0 mg/dL
- •No other prior or concurrent invasive malignancy in the past 5 years except nonmelanoma skin cancer
- •No active infection
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •At least but no more than 2 prior chemotherapy regimens containing carboplatin, cisplatin, or another organoplatinum compound combined with paclitaxel
- •Second line therapy may include any agents except topoisomerase I inhibitors (i.e., topotecan)
- •No prior nitrocamptothecin or topoisomerase I inhibitors
- •At least 3 weeks since prior chemotherapy and recovered
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •At least 3 weeks since prior radiotherapy and recovered
- •At least 3 weeks since prior surgery and recovered
- •No prior cancer therapy that contraindicates this study
排除标准
- 未提供
研究者
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