NCT01100372Unknown2 期
Randomized Phase II AGO-Study Comparing Combined Liposomal Doxorubicin (Myocet) and Gemcitabine (Gemzar) With Liposomal Doxorubicin (Myocet) Monotherapy in Platinum-Refractory and Platinum-Resistant Epithelial Cancer of the Ovary, Fallopian Tube and the Peritoneum
Medical University Innsbruck1 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2009年7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
- 154
- 试验地点
- 1
- 主要终点
- Remission rates (complete response and partial response)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as liposome-encapsulated doxorubicin citrate and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether liposome-encapsulated doxorubicin citrate is more effective when given together with or without gemcitabine hydrochloride in killing tumor cells.
PURPOSE: This randomized phase II trial is studying liposome-encapsulated doxorubicin citrate given together with gemcitabine hydrochloride to see how well it works compared with liposome-encapsulated doxorubicin citrate alone in treating patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.
详细描述
OBJECTIVES:
Primary
- To assess the response rate to liposome-encapsulated doxorubicin citrate and gemcitabine hydrochloride versus liposome-encapsulated doxorubicin citrate alone in patients with platinum-refractory or platinum-resistant ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer.
Secondary
- To assess the quality of life of patients treated with these regimens.
- To determine the progression-free and overall survival of patients treated with these regimens.
- To determine the toxicity of these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer
- •Progression or recurrence during first-line platinum-based chemotherapy (platinum-refractory disease) OR progression or recurrence during the first 6 months following the end of the last platinum-containing chemotherapy (platinum-resistant disease)
- •Meets ≥ 1 of the following criteria:
- •Measurable metastatic disease on CT or MRI scan, ultrasound, or chest x-ray
- •Evaluable disease on CT/MRI scan (e.g., ascites or pleural effusion) or chest x-ray (e.g., pleural effusion)
- •Tumor marker progression (CA-125) according to Rustin criteria, meeting 1 of the following criteria:
- •CA-125 > 2 times upper limit of normal (UNL)
- •CA-125 > 2 times nadir value on two occasions
- •No ovarian carcinosarcoma (malignant mixed Müllerian tumor) or pure sarcoma
- •PATIENT CHARACTERISTICS:
- •Karnofsky performance status 70-100%
- •Life expectancy ≥ 3 months
- •Platelet count ≥ 100,000/mm³
- •Hemoglobin ≥ 10 g/dL
- •Neutrophil count ≥ 1.5 x 10³/mm³
- •Serum creatinine < 1.5 times ULN
- •Bilirubin < 1.5 times ULN (< 2.5 times ULN if liver metastases are present)
- •AST/ALT < 2.5 times ULN (unless caused by parenchymal liver metastases)
- •No childbearing capacity
- •LVEF ≥ 50% by ECHO or MUGA scan
- •No significant comorbidity (e.g., uncontrolled infection, clinical signs of cardiac insufficiency, history of myocardial infarction, or cardiac rhythmic disorders [NYHA class III-IV disease])
- •No known hypersensitivity to study drugs
- •No active secondary malignant tumor within the past 5 years (e.g., metastases from primary breast cancer)
- •No condition (medical, social, or psychological), that would prevent adequate follow-up
- •PRIOR CONCURRENT THERAPY:
- •No prior chemotherapy with pegylated liposomal doxorubicin hydrochloride, other anthracyclines, or gemcitabine hydrochloride
- •No other concurrent tumor-specific therapy for ovarian cancer
排除标准
- 未提供
结局指标
主要结局
Remission rates (complete response and partial response)
次要结局
- Toxicity
- Quality of life as measured by EORTC-QLQ30 and QLQ-OV28 questionnaires
- Progression-free survival
- Overall survival
研究者
研究点 (1)
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