A Phase II Study of Oxaliplatin in Hepatocellular Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Response rate evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST)
研究概览
简要总结
Phase II trial to study the effectiveness of oxaliplatin in treating patients who have unresectable, recurrent or metastatic liver cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
详细描述
PRIMARY OBJECTIVES:
I. To assess response rate and progression free survival in patients with hepatocellular cancer treated with oxaliplatin.
II. To assess the toxicity and tolerance of oxaliplatin in patient with hepatocellular cancer.
III. To evaluate the mRNA expression of enzymes in tumors of the patients entered on this study which may be important to the cytotoxicity of oxaliplatin (ERCC1, mismatch repair, ribonucleotide reductase, bcl-2, bax, p53). An attempt will be made to obtain tumor biopsies from all patients.
OUTLINE: This is a multicenter study. Patients are stratified according to presence of the fibrolamellar variant of hepatocellular cancer (yes vs no).
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 HCC 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 >= 100,000/μl
- •Total bilirubin < 3.0 g/dl
- •AST(SGOT)/ALT(SGPT) =< 5 X institutional upper limit of normal
- •Creatinine < 2.0 OR measured 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
- •The effects of oxaliplatin on the developing human fetus at the recommended therapeutic dose are unknown; for this reason and because DNA alkylating agents are known to be teratogenic, women of child-bearing 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
- •Because the risk of toxicity in nursing infants secondary to oxaliplatin treatment of the mother is unknown but may be harmful, breastfeeding should be discontinued if the mother is treated with oxaliplatin
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Patient has prior oxaliplatin 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
研究组 & 干预措施
Treatment (oxaliplatin)
Patients receive oxaliplatin IV over 2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: oxaliplatin (Drug)
Treatment (oxaliplatin)
Patients receive oxaliplatin IV over 2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Response rate evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST)
时间窗: Up to 6 years
Confidence intervals for the response rate will be established by calculating exact 95% confidence limits for a binomial parameter.
Time to progression
时间窗: Up to 6 years
次要结局
- Duration of overall survival(Up to 6 years)
- Progression-free survival(Up to 6 years)