NCT03026803终止2 期
A Phase II Study of Oxaliplatin and Capecitabine in Unresectable Metastatic Hepatocellular Cancer
City of Hope Medical Center1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2006年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Response Rate
研究概览
简要总结
This phase II trial is studying how well giving oxaliplatin and capecitabine together works in treating patients with liver cancer.
详细描述
Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving these drugs together may kill more tumor cells.
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
- •Patients must have histologically confirmed hepatocellular carcinoma which is recurrent, metastatic or unresectable.
- •Patients may have up to two prior chemotherapy regimes. In addition, they may have had previous radiation, chemoembolization, and/or alcohol injections.
- •Patients must have measurable disease, defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, and which has clearly progressed during the observation interval prior to participation in this study. Pleural effusions and ascites will not be considered measurable, but may be present in addition to the measurable lesion(s).
- •Karnofsky performance status > 70%.
- •Patients should have an expected survival of at least 2 months.
- •Leukocytes >3,000/µl
- •Absolute neutrophil count >1,500/µl
- •Platelets >50,000/µl
- •Total bilirubin < 3.0 g/dl
- •AST (aspartate aminotransferase) (serum glutamic oxaloacetic transaminase(SGOT)/ALT (alanine aminotransferase) (serum glutamic pyruvic transaminase)(SGPT) < 5 times institutional upper limit of normal
- •Creatinine < 2.0 OR measured or calculated creatinine clearance >60 mL/min for patients with creatinine levels above institutional normal
- •Brain metastasis is not an exclusion, however, patients are only eligible if they have had successful control of the brain tumor(s) by surgery or stereotactic RT.
- •Patients with no evidence of clinically significant neuropathy.
- •All prior therapy must have been completed at least 4 weeks prior to the patient's entry on this trial.
- •Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- •Breastfeeding should be discontinued if the mother is treated with oxaliplatin.
- •Subjects with chronic hepatitis B or C may be undergoing treatment with α interferon and/or ribavirin, as long as they meet the other criteria for entry on to this study.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patients have prior oxaliplatin or xeloda treatment or undergoing therapy with other investigational agents.
- •History of allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with protocol-directed chemotherapy.
- •Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, or unstable angina pectoris, or cardiac arrhythmia.
- •HIV-positive patients receiving anti-retroviral therapy (HAART) are excluded from the study because of possible pharmacokinetic interactions.
- •Patients with a diagnosis of pulmonary fibrosis or a pulmonary interstitial process.
- •Patients unable to swallow capecitabine will be excluded from this study.
研究组 & 干预措施
Oxaliplatin and Capecitabine
Experimental
21 day cycle with Oxaliplatin 50mg/m2 day 1 and day 8 administered IV, Capecitabine 750 mg/m2 bid p.o. daily from day 1 to day 14
干预措施: Oxaliplatin (Drug)
Oxaliplatin and Capecitabine
Experimental
21 day cycle with Oxaliplatin 50mg/m2 day 1 and day 8 administered IV, Capecitabine 750 mg/m2 bid p.o. daily from day 1 to day 14
干预措施: Capecitabine (Drug)
结局指标
主要结局
Response Rate
时间窗: Up to 2 years
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Phase II (Treatment) Study of Oxaliplatin and Capecitabine in Advanced Head and Neck MalignanciesHead or Neck CancerNCT00266279University of Louisville17
终止
2 期
Title XELOX FOR SALIVARY GLAND CANCERSHead and Neck CancerNCT00101075Dana-Farber Cancer Institute9
已完成
2 期
Oxaliplatin and Capecitabine in Patients With Unresectable CholangiocarcinomaCancer of the GallbladderCancer of the Biliary TractNCT00338988M.D. Anderson Cancer Center44
已完成
2 期
Phase II Trial Assessing Efficacy and Toxicity of Capecitabine and Oxaliplatin in the Treatment of Colorectal CancerColorectal CancerNCT00220116Royal Marsden NHS Foundation Trust172
已完成
2 期
Oxaliplatin and Capecitabine in the Treatment of Relapsed/Refractory Carcinoma of Unknown Primary SiteNeoplasms, Unknown PrimaryNCT00193609SCRI Development Innovations, LLC48