Multicenter, Prospective Phase-I/II-study: Topotecan and Carboplatin in the Therapy of Patients With Relapsed Ovarian Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 主要终点
- Occurrence of a DLT (Dose Limiting Toxicity)
研究概览
简要总结
Compatibility of the topotecan therapy in combination with carboplatin.
详细描述
The aim of the study was to confirm the tolerability of 3-day topotecan therapy in combination with carboplatin in accordance with published data and to investigate the tolerability of continued therapy until disease progression or up to a maximum of 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Age >= 18 years
- •patient with ovarian cancer after primary therapy
- •bone marrow function leukocytes >= 4,0 x 109/ l, platelets >= 100 109/l, hemoglobin >= 9 g/dl
- •renal function creatinin <= 1,5 mg% or creatinin clearance >= 60 ml/min
- •liver function bilirubin <= 2,0 mg/dl, SGOT, SGPT and AP within 3 fold of the reference laboratory's normal range
- •ECOG <= 2
- •Intention of regular follow-up visits for the duration of the study
- •written informed consent
排除标准
- •any known hypersensitivity against topotecan isomerase-I-inhibitor other medication included in the study protocol
- •ECOG > 2
- •patients with radiotherapy within the last 4 weeks
研究组 & 干预措施
Relapse 6-12 months
dose level 0: Topotecan 1mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application)
If dose limiting toxicity (DLT) is present then Topotecan dose will be reduced to dose level -1 (dose level -1: Topotecan 0.75 mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application))
A DLT is present if a patient has a postponement due to hematologic toxicity of more than 7 days within the first four courses at dose level 0.
干预措施: Hycamtin (Drug)
Relapse >12 months
dose level 0: Topotecan 1mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application)
If dose limiting toxicity (DLT) is present then Topotecan dose will be reduced to dose level -1 (dose level -1: Topotecan 0.75 mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application))
A DLT is present if a patient has a postponement due to hematologic toxicity of more than 7 days within the first four courses at dose level 0.
干预措施: Hycamtin (Drug)
结局指标
主要结局
Occurrence of a DLT (Dose Limiting Toxicity)
时间窗: after each cycle for up to one year
A DLT is present if a patient has a postponement due to hematologic toxicity of more than 7 days within the first four courses at dose level 0.
次要结局
- Progression-free Survival (PFS)(after every third cycle, for up to one year)