Sorafenib Plus Paclitaxel in Adreno-Cortical-Cancer Patients (PAXO)
Sorafenib Plus Paclitaxel Metronomic Chemotherapy in Adreno-Cortical-Carcinoma Patients Progressing After 1st or 2nd Line Cytotoxic Chemotherapy
研究概览
详细说明
The study is designed as a Phase II, prospective, non randomized, open-label, single arm, multicenter trial, in which patients with locally advanced or metastatic ACC not amenable to complete surgical resection.
STUDY OBJECTIVES
The aim of this phase II trial is to evaluate the clinical benefit and toxicity of the combination of Sorafenib plus metronomic chemotherapy in patients with locally advanced or metastatic ACC who progressed after first or second line chemotherapy.
Primary objective
To assess the clinical benefit as measured by a non progressing rate after 4 months of the combination of Sorafenib plus weekly Paclitaxel in patients with locally advanced or metastatic ACC who progressed after first or second line chemotherapy.
Secondary objectives
- Assessment of Objective (Complete and Partial) Response Rates
- Assessment of Duration of Response
- Assessment of Hormonal Response
- Assessment of Progression-Free Survival
- Assessment of Overall Survival
- Assessment of the relationship between specific "biomarkers" and cancer- and treatment-related outcomes
- Assessment of Quality of Life by EORTC QLQ-C30
- Assessment of Toxicity
ENDPOINTS
The first disease assessment will be performed after 8-weeks, subsequent assessments will be performed every 12 weeks until end of the study.
Primary endpoint
- Progression-Free Survival rate ≥ 40% after 4 months
Secondary endpoints
- Response rate evaluation will be performed according to the RECIST criteria. The same methods of measurement and the same technique should be used to characterize each identified and reported lesion at baseline and during study.
TREATMENT SCHEME Treatment scheme consisted of oral Sorafenib 400 mg p.o. bid plus intravenous Paclitaxel 60 mg/mq/weekly i.v., until disease progression.
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
-
-
-
Orbassano、意大利
- 招聘中
- Department of Clinical and Biological Sciences, University of Turin
-
首席研究员:
- Alfredo Berruti
-
接触:
- Paola Perotti
- 电话号码:Ext. 017 : +390119026
-
Padova、意大利
- 尚未招聘
- Azienda Ospedaliera di Padova
-
接触:
- Franco Mantero
-
副研究员:
- Franco Mantero
-
Palermo、意大利
- 尚未招聘
- Azienda Ospedaliera Università di Palermo
-
副研究员:
- Vittorio Gebbia
-
Roma、意大利
- 尚未招聘
- Policlinico Universitario Campus Biomedico- Roma
-
副研究员:
- Daniele Santini
-
Rozzano、意大利
- 尚未招聘
- Ist. Clin.Humanitas
-
接触:
- Carlo Carnaghi
-
副研究员:
- Carlo Carnaghi
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Histologically confirmed diagnosis of ACC
- Locally advanced or metastatic disease not amenable to radical surgery resection
- Radiologically monitorable disease
- Progressing disease after one or two cytotoxic chemotherapy regimens (including a platin-based protocol)
- ECOG performance status 0-2
- Life expectancy ≥ 3 months
- Subjects with at least one uni-dimensional(for RECIST) or bi-dimensional(for WHO) measurable lesion. Lesions must be measured by CT-scan or MRI
- Age ≥ 18 years
- Adequate bone marrow reserve (neutrophils ≥ 1500/mm³ and platelets ≥ 80.000/mm³)
- Hemoglobin > 9.0 g/dl
- Total bilirubin < 1.5 times the upper limit of normal
- PT-INR/PTT < 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.]
- Serum creatinine < 1.5 x upper limit of normal
- Effective contraception in pre-menopausal female and male patients
- Patient´s written informed consent
- Ability to comply with the protocol procedures
Exclusion criteria:
- History of prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, or other treated malignancies with no evidence of disease for at least three years.
- History of HIV infection or chronic hepatitis B or C (This criteria should be modified to allow Hepatitis B or C in protocols looking at HCC patient population)
- Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
- Symptomatic metastatic brain or meningeal tumors (unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry)
- Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
- History of organ allograft The organ allograft may be allowed as protocol specific
- Severe renal (serum creatinine > 2.5 x ULN) or hepatic insufficiency (ALT / - AST > 2.5 x ULN or ALT/AST >5 x ULN if liver function abnormalities are due to the underlying malignancy and/or total serum bilirubin > 2.5 x ULN)
- Concomitant Rifampicin
- Concomitant St. John's Wort (Hypericum perforatum)
- Warfarin is allowed; however, close monitoring of Prothrombin Time (PT) is recommended
- Decompensated heart failure (ejection fraction <45%), myocardial infarction or revascularization procedure during the last 6 months, unstable angina pectoris, uncontrolled cardiac arrhythmia
- Hypertension that cannot be controlled by medications (>160/100 mmHg despite optimal medical therapy)
- Patients with recent or active bleeding diathesis
- Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment.
- Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and three months after the completion of trial
- Previous treatment with Sorafenib or other anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry
- Radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy will be allowed).
- Major surgery within 4 weeks of start of study
- Autologous bone marrow transplant or stem cell rescue within 4 months of study
- Use of biologic response modifiers, such as G-CSF, within 3 week of study entry. [G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator, however they may not be substituted for a required dose reduction.] [Patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study or during the study]
- Current treatment with another investigational drug
- Any other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:1 arm only
One arm only with Sorafenib plus Paclitaxel Patients enrolled will undergo strict follow-up Intervention: Sorafenib plus Paclitaxel |
Treatment scheme consisted of oral Sorafenib 400 mg p.o. bid until disease progression.
Intravenous Paclitaxel 60 mg/mq/weekly i.v., until disease progression.
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Disease free survival
大体时间:4 months
|
4 months
|
次要结果测量
结果测量 |
大体时间 |
---|---|
Overall survival
大体时间:4 months
|
4 months
|
合作者和调查者
调查人员
- 学习椅:Alfredo Berruti MD、Internal Medicine, Department of Clinical and Biological Sciences, University of Turin, Italy
- 研究主任:Eric Baudin、Oncologie Endocrinienne et Médecine Nucléaire, Institut Gustave Roussy, Villejuif, France.
- 首席研究员:Massimo Terzolo, MD、Internal Medicine, Department of Clinical and Biological Sciences, University of Turin, Italy
- 研究主任:Sophie Leboulleux、Service de Médecine Nucléaire et de Cancérologie Endocrinienne, Institut Gustave-
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.