JPRN-UMIN000002879已完成1 期
Phase I study of pegylated liposomal doxorubicin (PLD) in combination with docetaxel (TXT) in recurrent or refractory ovarian cancer (epithelial ovarian carcinoma, fallopian tube carcinoma, or primary peritoneal carcinoma) - KCOG G-0901
Kansai Clinical Oncology Group0 个研究点目标入组 48 人开始时间: 2009年12月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
研究概览
简要总结
48 patients were enrolled, and 46 were eligible to receive the treatment. The patients median age was 61 years . two cases of carcinosarcoma, and two cases of clear cell carcinoma by histology. Twenty-nine participants received >=6 cycles of chemotherapy. The RR was 71.3% .
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 75years-old（—）
- 性别
- Female
入选标准
- 未提供
排除标准
- •1) Patients with complications (severe complications or active systemic infection) that may affect the study or assessment of the drugs) 2) Patients with diagnosis of active multiple cancers (synchronous multiple cancers and metachronous multiple cancers within 5 years of disease free interval: exceptions are basal cell carcinoma and squamous cell carcinoma, carcinoma in situ that is curatively treated by local treatment, and intramucosal carcinoma like lesion.) 3) Patients with angina or myocardial infarction within the past 90 days (previous day of the enrollment is defined as day 1 and up to 90 days) 4) Patients who have brain metastasis with symptoms or patients with brain metastasis requiring administration of steroid or antihydropic 5) Patients who have received prior bone marrow transplantation, or high-dose chemotherapy and hematopoietic stem cell transplantation 6) Patients who have received prior chemotherapy consisting of anthracycline (including PLD) or docetaxel 7) Patients with history of hypersensitivity reactions to the components of anthracycline, taxane, or liposomal doxorubicin (MPEG-DSPE, hydrogenated lecithin, cholesterol, ammonium sulfate, histidine, sucrose, hydrochloric acid, sodium hydroxide) 8) Patients who are pregnant, lactating, and have pregnant possibility or intention 9) Patients who are decided to be ineligible for this study by the principal investigator (or subinvestigator)
研究者
相似试验
已完成
不适用
Phase I Trail of pegylated liposomal doxorubicin (PLD) in combination with Irinotecan (CPT-11) in Patients with Platinum Refractory and Resistant Ovarian cancerPatients with platinum-refractory and resistant ovarian cancerJPRN-UMIN000005525Fukuoka University, School of Medicine6
招募中
1 期
Phase I study of pegylated liposomal doxorubicin and cisplatin combination chemotherapy in patients with recurrent and refractory epithelial ovarian cancer.epithelial ovarian cancer, primary fallopian tube cancer, primary peritoneal cancerJPRN-UMIN000005798Cancer Institute Hospital18
进行中（未招募）
不适用
Phase II Study Evaluating PegLiposomal Doxorubicin (PLD) and Carboplatin Combination Chemotherapy in Gynecological Sarcomas and Mixed Epithelial-Mesenchymal TumorsGynecologic Sarcomas and Mixed Epithelial-Mesenchymal TumorsEUCTR2008-000245-55-DEGYN Research GmbH
进行中（未招募）
不适用
Phase II study of pegylated liposomal doxorubicin (Caelyxâ) in breast cancer patients with brain metastases and not candidate for an antiHER2 therapy - AROBASEBreast Cancer Patients with Brain MetastasesMedDRA version: 9.1Level: PTClassification code 10055113Term: Breast cancer metastaticMedDRA version: 9.1Level: LLTClassification code 10027475Term: Metastatic breast cancerEUCTR2007-006790-81-FRAPREC50
招募中
2 期
A Phase II Trial of Liposomal Doxorubicin (PLD, DOXILTM) as 3rd Line Treatment in Relapsed, Plutinum - resistant Ovarian CancerOvarian CancerJPRN-UMIN000002814Osaka University Faculty of Medicine Department of obstetrics and gynecology43