Phase II Trial of Cabazitaxel in Metastatic or Inoperable Locally Advanced Dedifferentiated Liposarcoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 11
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
Soft tissue sarcomas (STS) are a rare group of malignant heterogenous tumors (> 50 histological subtypes, including liposarcoma, the commonest subtype of STS) with distinct genetic, pathological and clinical profiles, and varying patterns of tumor spread. The optimal cytotoxic treatment for this group of patients remains uncertain. Single agents which are most effective include doxorubicin and ifosfamide, but objective response rates and progression-free survival times remain modest. There is clearly a need to improve treatment options for liposarcoma. Eribulin, a antimicrotubule agent that targets the protein tubulin in cells, interfering with cancer cell division and growth , has demonstrated activity in STS. Therefore, it is reasonable to explore whether other anti-microtubule agent like cabazitaxel have a role in STS. Cabazitaxel has been shown to be a relatively safe, effective and tolerated. This drug has been approved by FDA for prostate cancer. The main objective of this trial is to determine whether cabazitaxel demonstrate sufficient antitumor activity for liposarcoma.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Local diagnosis of dedifferentiated liposarcoma
- •Age 18-75 yrs
- •WHO performance status 0-1
- •Radiological or histological diagnosis of inoperable locally advanced or metastatic disease, with evidence of disease progression within the past 6 months
- •Clinically and/or radiographically documented measurable disease within 21 days prior to randomization.At least one site of disease must be unidimensionally measurable according to RECIST 1.
- •One previous chemotherapy regimen for locally advanced or metastatic dedifferentiated liposarcoma (this could include pre-operative chemotherapy for primary disease if subsequent complete resection was not achieved).
- •Adequate haematological, renal and hepatic function
- •Birth control measures
- •Estimated life expectancy > 3 months
- •Related adverse events from previous therapies ≤ Grade 1
- •Written informed consent
排除标准
- •More than 1 prior molecularly targeted therapy (e.g. CDK4 inhibitor). Any prior such therapy must be completed at least 4 weeks before randomization.
- •Symptomatic CNS metastases
- •Previous encephalopathy of any cause or other significant neurological condition
- •Concurrent or planned treatment with strong inhibitors or inducers of cytochrome P450 3A4/5
- •Pregnancy
- •inflammation of the urinary bladder (cystitis)
- •Other invasive malignancy within 5 years (exceptions of non-melanoma skin cancer, localized cervical cancer, localized and presumably cured prostate cancer or adequately treated basal or squamous cell skin carcinoma)
- •Significant cardiac disease
- •Uncontrolled severe illness or medical condition, other than DD liposarcoma
- •Hypersensitivity to taxanes or their excipients
研究组 & 干预措施
Cabazitaxel
INN: Cabazitaxel Cabazitaxel will be administered at a dose of 25 mg/m² by intravenous infusion, over 1 hour, on day 1 of each 21 day cycle.
Treatment should be administered until disease progression, unacceptable toxicity or patient's refusal.
干预措施: Cabazitaxel (Drug)
结局指标
主要结局
Progression free survival (PFS)
时间窗: 3 years from first patient in
The primary endpoint will be progression free survival, assessed at 12 weeks after start of treatment
次要结局
- Time to progression(3 years from first patient in)
- Objective tumor response(3 years from first patient in)
- Time to onset of response(3 years from first patient in)
- Progression free survival(3 years from first patient in)
- Duration of response(3 years from first patient in)
- Overall survival(3 years from first patient in)
- Occurence of adverse events(3 years from first patient in)