NCT00786110Unknown2 期
Sorafenib Plus Paclitaxel Metronomic Chemotherapy in Adreno-Cortical-Carcinoma Patients Progressing After 1st or 2nd Line Cytotoxic Chemotherapy
University of Turin, Italy5 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2008年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 5
- 主要终点
- Disease free survival
研究概览
简要总结
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 and progressing to cytotoxic chemotherapy will receive Sorafenib plus metronomic chemotherapy as treatment.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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
1 arm only
Experimental
One arm only with Sorafenib plus Paclitaxel Patients enrolled will undergo strict follow-up
Intervention: Sorafenib plus Paclitaxel
干预措施: Sorafenib (Drug)
1 arm only
Experimental
One arm only with Sorafenib plus Paclitaxel Patients enrolled will undergo strict follow-up
Intervention: Sorafenib plus Paclitaxel
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Disease free survival
时间窗: 4 months
次要结局
- Overall survival(4 months)
研究者
研究点 (5)
Loading locations...
相似试验
进行中（未招募）
不适用
Sorafenib plus paclitaxel metronomic chemotherapy in adreno-cortical-carcinoma patients progressing after 1st or snd line cytotoxic chemotherapy - PAXOACCMedDRA version: 9.1Level: SOCClassification code 10014698Term: Endocrine disordersMedDRA version: 9.1Level: LLTClassification code 10001326Term: Adrenal carcinomaEUCTR2008-000759-91-ITAZIENDA OSPEDALIERA S. LUIGI GONZAGA25
招募中
2 期
Nimotuzumab Combined With Sintilimab and Chemotherapy for Advanced Esophageal Squamous Cell CarcinomaEsophageal CancerNCT06718205The First Affiliated Hospital of Zhengzhou University112
已完成
2 期
A Phase II Randomized, Double-blind, Placebo-controlled Study of Sorafenib or Placebo in Combination With Transarterial Chemoembolization (TACE) Performed With DC Bead and Doxorubicin for Intermediate Stage Hepatocellular Carcinoma (HCC).Carcinoma, HepatocellularNCT00855218Bayer307
已完成
2 期
Efficacy Study of Sorafenib and Cyclophosphamide to Treat Neuroendocrine TumorsNeuroendocrine TumorsNCT00605566University Health Network, Toronto22
进行中（未招募）
2 期
Sorafenib in Combination With Carboplatin and Paclitaxel in Treating Participants With Metastatic or Recurrent Head and Neck Squamous Cell CancerMetastatic Head and Neck Squamous Cell CarcinomaMetastatic Squamous Cell Carcinoma of the HypopharynxMetastatic Squamous Cell Carcinoma of the LarynxMetastatic Squamous Cell Carcinoma of the Oral CavityMetastatic Squamous Cell Carcinoma of the OropharynxRecurrent Head and Neck Squamous Cell CarcinomaRecurrent Hypopharyngeal Squamous Cell CarcinomaRecurrent Laryngeal Squamous Cell CarcinomaRecurrent Oral Cavity Squamous Cell CarcinomaRecurrent Oropharyngeal Squamous Cell CarcinomaNCT00494182M.D. Anderson Cancer Center48