ACTRN12605000390684进行中（未招募）2 期
A phase II trial of weekly docetaxel (Taxotere) for patients with relapsed ovarian cancer who have previously received paclitaxel
HMRC Clinical Trial Centre c/- Univ of Sydney0 个研究点目标入组 60 人开始时间: 2005年9月14日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- ot stated 至 ot stated（—）
- 性别
- Female
入选标准
- •* Histologically proven epithelial carcinoma of the ovary, primary peritoneal carcinoma or fallopian tube carcinoma. * Patients must have previously received paclitaxel, and relapsed or progressed after cessation of paclitaxel. * Patients must have been treated previously with at least one platinum-containing chemotherapy regimen (platinum refers to either carboplatin or cisplatin). * Patients must have disease that is unidimensionally measurable or be suitable for assessment of CA125 response. Patients without measurable disease who are to be followed by CA125 must have a CA125 > 70 U/ml. * Patients may or may not have received hormonal therapy, immunotherapy or localized radiation therapy (previous radiotherapy exposure should not compromise the evaluation of the measurable/evaluable disease sites). Patients must have been off all previous non-cytotoxic therapy for at least four weeks before study entry and must have recovered from the effects of prior therapy. For patients on hormonal therapy who have clear evidence of progression on this treatment, a 2-week interval will be acceptable. Prior radiotherapy should have involved < 25% of bone marrow. * No prior chemotherapy/investigational drug therapy in the 4 weeks preceding study entry. In case of previous treatment with mitomycin-C, high-dose carboplatin (dose > 600mg/m2 or > AUC 7) or nitrosoureas, a 6-week interval will be required. * WHO performance status 0-2. * Non-pregnant, non-lactating female patients. Patients of childbearing potential must implement adequate contraceptive measures during study participation. * Age > 18 years. * Life expectancy greater than or equal to 12 weeks. * Adequate haematological, renal and hepatic functions as defined by: (i) Haematology: - Neutrophils > 1.5 x 109/l- Platelets > 100 x 109/l. (ii) Hepatic function:- Total bilirubin < upper-normal limit (UNL). - AST and ALT < 2.5 x UNL. - ALP < 5 x UNL (unless patient has bone metastases without any malignant or non-malignant liver disease). - Patients with AST and /or ALT > 1.5 x UNL associated with ALP > 2.5 x UNL are not eligible for the study. (iii) Renal function: - Creatinine < 1.5 x UNL. * Patient's written informed consent must be obtained before any study specific screening procedures are performed, and in accordance to the local Ethics Committee requirements. * Patients must be accessible for treatment and follow-up.
排除标准
- •No exclusion criteria
研究者
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