A Phase II Study of Oxaliplatin Combined With Continuous Infusion Topotecan as Chemotherapy for Patients With Previously Treated Ovarian Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Clinical Response Rate (Complete and Partial Response by RECIST and/or CA [Cancer Antigen] 125)
研究概览
简要总结
This phase II trial is studying how well giving oxaliplatin together with topotecan works in treating patients with ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer. Drugs used in chemotherapy, such as oxaliplatin and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
详细描述
PRIMARY OBJECTIVES:
I. Estimate the overall clinical response rate (complete and partial responses) in patients with previously treated ovarian epithelial, primary peritoneal, or fallopian tube cancer treated with oxaliplatin and topotecan.
II. Determine the toxic effects in patients treated with this regimen.
SECONDARY OBJECTIVES:
I. Estimate the time to progression and overall clinical response duration in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Histologically or cytologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer
- •Meets 1 of the following criteria for response to prior platinum-based therapy:
- •Platinum-resistant disease, defined as a disease-free interval of < 6 months after prior platinum-based therapy OR progressive disease on a platinum-containing regimen
- •Platinum-sensitive disease, defined as a disease-free interval of > 6 months after prior platinum-based therapy
- •Measurable or evaluable disease: Measurable disease is characterized as lesions reproducibly measurable in 1 dimension; evaluable disease is defined as known disease with CA125 levels > 50 U/mL on 2 occasions >= 1 week apart
- •Previously treated with a taxane and platinum-based regimen, only 1 prior platinum-based regimen, including IV or intraperitoneal consolidation, one additional non-platinum and non-topotecan chemotherapy regimen allowed
- •Life expectancy >= 4 months
- •Total bilirubin =< 1.5 times upper limit of normal (ULN)
- •AST =< 2.5 times ULN (5 times ULN if liver metastases are present)
- •Creatinine =< 1.5 times ULN AND creatinine clearance > 40 mg/dL
- •Exclusion criteria:
- •No presence of any other active cancer
- •No uncontrolled intercurrent illness, including the following:
- •Infection
- •Symptomatic congestive heart failure
- •Unstable angina pectoris
- •Cardiac arrhythmia
- •No history of severe allergy to platinum compounds
- •(Mild reaction (skin only) allowed provided a negative skin test is obtained)
- •No history of allergic reaction to appropriate antiemetics (e.g., 5HT3 antagonists)
- •Recovered from prior chemotherapy
- •At least 2 weeks since prior radiotherapy and recovered
- •At least 4 weeks since prior investigational drugs
- •No prior radiotherapy to the whole pelvic field
- •No unresolved sequelae resulting from any surgical procedures
- •No concurrent colony-stimulating factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF]) during topotecan infusion
- •No concurrent participation in another investigational trial
- •No other concurrent investigational agents
- •No other concurrent anticancer therapy
排除标准
- 未提供
研究组 & 干预措施
Treatment (oxaliplatin plus topotecan)
Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.
干预措施: oxaliplatin (Drug)
Treatment (oxaliplatin plus topotecan)
Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.
干预措施: topotecan (Drug)
结局指标
主要结局
Clinical Response Rate (Complete and Partial Response by RECIST and/or CA [Cancer Antigen] 125)
时间窗: Every two cycles for up to 24 weeks.
Tumor response was assessed every two cycles by CT/MRI using RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) for target lesions: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): \>= 30% decrease in the sum of the longest diameter (LD) of target lesions; Overall Response (OR) = CR + PR.
次要结局
- Time to Disease Progression by RECIST and/or CA 125(Tumor measurements will be performed every 8 weeks until the date of first documented progression up to 100 weeks)