NCT01100359Unknown2 期
Phase II Multicenter Trial of the Austrian AGO With the Combination of Liposomal Doxorubicin (Myocet®) and Carboplatin in Primary Advanced or Metastatic and Recurrent Endometrial Cancer
Medical University Innsbruck2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2007年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Response rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as liposome-encapsulated doxorubicin citrate and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well liposome-encapsulated doxorubicin citrate given together with carboplatin works in treating patients with advanced or metastatic recurrent endometrial cancer.
详细描述
OBJECTIVES:
Primary
- To assess activity of the combination of liposome-encapsulated doxorubicin citrate and carboplatin in patients with primary advanced or metastatic recurrent carcinoma of the endometrium.
Secondary
- To assess the toxicity and feasibility of this regimen in these patients.
- To determine the progression-free survival and overall survival of these patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of endometrial carcinoma, including any of the following cellular types:
- •Mixed Mullerian carcinoma
- •Serous carcinoma
- •Clear cell carcinoma
- •Primary advanced (FIGO stage III or stage IV) or metastatic recurrent disease
- •Disease not curable by surgery
- •Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm with x-ray, physical exam, or non-spiral CT scan OR ≥ 10 mm with spiral CT scan or MRI
- •No known cerebral metastases
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Life expectancy ≥ 12 weeks
- •Platelet count ≥ 100,000/mm^3
- •ANC ≥ 1,500/mm^3
- •Hemoglobin ≥ 10 g/dL
- •Creatinine ≤ 1.25 times upper limit of normal (ULN)
- •Bilirubin ≤ 1.25 times ULN
- •AST/ALT < 3 times ULN
- •Glomerular filtration rate ≥ 50 mL/min
- •LVEF ≥ 50% by ECHO
- •Fertile patients must use effective contraception
- •No myocardial infarction within the past 6 months
- •No NYHA class II-IV congestive heart failure
- •No third degree or complete heart block unless a pacemaker is in place
- •No other malignancy within the past 5 years
- •No concomitant medical illness (e.g., uncontrolled infection, uncontrolled angina, or other relevant illness) that makes the prescribed treatments within this study unfeasible
- •No known hypersensitivity to study drugs
- •No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- •PRIOR CONCURRENT THERAPY:
- •No prior chemotherapy for disease recurrence
- •At least 12 months since prior adjuvant therapy containing anthracyclines with cumulative doses not exceeding the following:
- •Epirubicin 600 mg/m²
- •Doxorubicin 300 mg/m²
- •At least 6 months since prior adjuvant therapy containing platinum
- •At least 4 weeks since completion of radiotherapy involving the whole pelvis
- •No concurrent radiotherapy or planned radiotherapy after study
- •No concurrent endocrine, immunological, or other anticancer therapy
- •No concurrent participation in another investigational drug study
排除标准
- 未提供
结局指标
主要结局
Response rate
次要结局
- Duration of progression-free survival
- Overall survival
- Safety
- Feasibility
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Combination Chemotherapy, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Newly Diagnosed Large B-Cell LymphomaLymphomaNCT00690560Centre Antoine Lacassagne30
已完成
2 期
Combination Chemotherapy Consisting of Pegylated Liposomal Doxorubicin and Carboplatin in Malignant Gynecologic TumoursCancer of the Ovary Treated as 2nd Line TherapyMuellerian Mixed TumoursTumours of the UterusCervical CancersNon-Epithelial Ovarian TumoursNCT00189410AGO Study Group140
已完成
2 期
Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage I or Stage II Hodgkin's LymphomaLymphomaNCT00086801Alliance for Clinical Trials in Oncology104
Unknown
2 期
Liposome-Encapsulated Doxorubicin Citrate With or Without Gemcitabine Hydrochloride in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity CancerFallopian Tube CancerOvarian CancerPrimary Peritoneal Cavity CancerNCT01100372Medical University Innsbruck154
已完成
2 期
Neoadjuvant Ifosfamide, Doxorubicin, Gemcitabine, and Cisplatin in Treating Patients Who Are Undergoing Radical Cystectomy for Locally Advanced Carcinoma (Cancer) of the UrotheliumTransitional Cell Cancer of the Renal Pelvis and UreterUrethral CancerBladder CancerNCT00080795M.D. Anderson Cancer Center65