Phase II Multicenter Study to Determine the Efficacy of Gemcitabine With Pazopanib as Second Line Treatment in Patients With Metastatic or Relapsed Uterine or Soft Tissue Leiomyosarcomas
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UNICANCER
- 入组人数
- 106
- 试验地点
- 17
- 主要终点
- Progression Free Survival
研究概览
简要总结
The aim of this research is to study the activity of pazopanib in second line after anthracyclines in extra uterus and uterine LMS in association with gemcitabine.
详细描述
Primary Objectives:
To determine the PFS using combination of gemcitabine and pazopanib in patients with metastasis or relapse leiomyosarcoma (uterine or soft tissue)who have already received s first line anthracycline based therapy.
Secondary objectives:
To determine the disease control rate To determine the response rate To determine toxicities associated with combined gemcitabine and pazopanib To determine correlation between metabolic response and PFS
Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of metastatic or relapsed of uterine or soft tissue leiomyosarcoma previously treated with one line of chemotherapy with at least an anthracycline. Patients who have received adjuvant therapy less than one year before relapse were considered to have received a first line therapy for metastatic disease)
- •Delay between the end of previous treatment (chemotherapy, hormonotherapy, radiotherapy, immunotherapy, surgery or tumor embolisation) must be > 4 weeks
- •At least one measurable lesion with RECIST criteria with progressive disease between the last 6 weeks between inclusion. One target at least must be in a non irradiated area
- •performance status ECOG ≤ 2
- •Age ≥ 18 years
- •Subjects must provide written informed consent prior to performance of study-specific procedures, and must be willing to comply with treatment and follow up
- •Adequate hematologic function
- •Adequate coagulation function
- •Adequate renal function
- •Adequate liver function
- •Patients must be affiliated to a Social Health Insurance
- •Women of childbearing potential must be using a medically accepted method of contraception and must have a negative serum pregnancy test within 14 days of enrollment and/or urine pregnancy test 72 hours prior to the administration of the first study treatment.
- •LVEF ≥ site limits
排除标准
- •Other uterine or soft tissue sarcomas
- •Symptomatic or known brain metastasis
- •Radiation therapy on the only evaluable lesion
- •Anti coagulant treatment
- •strong inhibitors or inducers of the isoenzyme CYP3A4 treatment
- •Known sero-positivity (HIV, HbC, HbS)or uncontrolled infection
- •other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix
- •Clinically significant gastrointestinal abnormalities that may affect the absorption of the IP
- •Corrected QT interval > 480 msec
- •Other serious underlying pathology that would preclude study treatment
- •Calcium and magnesium levels inferior to standard levels (measured within 14 days before the first pazopanib dose) and potassium levels inferior to standard levels (measured within 72 hours before the first pazopanib dose)
研究组 & 干预措施
pazopanib, gemcitabine
pazopanib tablets (200mg) per os, 800mg/day continuously gemcitabine IV, 2 injection per cycle
干预措施: pazopanib + gemcitabine (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: 9 months
To assess the 9-month Progression Free Survival in Patients With Metastatic or Relapsed Uterine or Soft Tissue Leiomyosarcomas and treated with Gemcitabine and Pazopanib
次要结局
- disease control rate and overall response rate(12 weeks)
- Safety of the combination Gemcitabine-Pazopanib(during the entire trial)
- metabolic response by using PET scan(6 weeks)