A Phase I Dose-Finding Study of Oxaliplatin (NSC #266046) Combined With Continuous Infusion Topotecan Hydrochloride as Chemotherapy for Patients With Previously Treated Ovarian Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
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 I trial to study the effectiveness of combining oxaliplatin with topotecan in treating patients who have previously treated ovarian epithelial, primary peritoneal, or fallopian tube cancer.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose and dose-limiting toxic effects of oxaliplatin and topotecan in patients with previously treated ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer.
- Determine the qualitative and quantitative toxic effects of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine the antitumor activity of this treatment regimen in these patients.
- Determine the correlation between the pharmacokinetic and safety data of this regimen in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with measurable disease who achieve a response may receive additional therapy at the discretion of the principal investigator.
Cohorts of 3-6 patients receive escalating doses of oxaliplatin and topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity.
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 or cytologically confirmed ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer
- •Prior chemotherapy required
- •Measurable or evaluable disease
- •No symptomatic, untreated brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •At least 4 months
- •Hematopoietic:
- •WBC greater than 3,000/mm^3
- •Absolute neutrophil count greater than 1,500/mm^3
- •Platelet count greater than 100,000/mm^3
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN) OR
- •SGOT no greater than 2.5 times ULN (5 times ULN if liver metastases)
- •Creatinine no greater than 1.5 times ULN OR
- •Creatinine clearance at least 50 mL/min
- •Cardiovascular:
- •No uncontrolled symptomatic congestive heart failure
- •No unstable angina pectoris
- •No uncontrolled cardiac arrhythmia
- •No other active cancer
- •No prior allergy to platinum compounds
- •No prior allergic reactions to appropriate antiemetics (e.g., serotonin or antagonists) administered concurrently with study
- •No other uncontrolled concurrent illness (e.g., infection)
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 6 months after study therapy
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •See Chemotherapy
- •No concurrent colony stimulating factors during topotecan administration
- •Chemotherapy:
- •See Disease Characteristics
- •No prior high-dose chemotherapy requiring bone marrow or peripheral blood stem cell transplantation
- •At least 4 weeks since prior chemotherapy and recovered
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •No prior radiotherapy to whole pelvic field
- •At least 2 weeks since prior radiotherapy and recovered
- •No unresolved sequelae resulting from prior surgery
- •At least 4 weeks since other prior investigational drug
- •No other concurrent investigational agents
- •No other concurrent anticancer therapy
排除标准
- 未提供