Capecitabine and Oxaliplatin in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Response Rate
研究概览
简要总结
There are limited treatment options available for patients with advanced pancreatic ductal adenocarcinoma (PDAC). The purpose of this study is to determine the effectiveness and safety of the drugs capecitabine and oxaliplatin in patients who have been diagnosed with advanced and metastatic PDAC treated in the first and second lines.
详细描述
OBJECTIVES:
Primary
- To determine the response rate to capecitabine and oxaliplatin in patients with locally advanced or metastatic pancreatic adenocarcinoma Secondary
- To determine safety
- To determine overall survival
- To determine time to progression
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
- •18 years of age or older
- •At most one prior chemotherapy regimen for unresectable or metastatic disease. Any adjuvant chemotherapy must have been completed more than 12 months prior to beginning protocol therapy
- •Histologically or cytologically confirmed adenocarcinoma of the pancreas
- •At least one measurable lesion according to RECIST criteria that has not been irradiated
- •Adequate laboratory parameters as outlined in protocol
- •Anticoagulation with coumadin is permitted, but PT/INR must be monitored closely, given the drug-drug interaction between coumadin and capecitabine
- •Negative serum pregnancy test within 14 days prior to registration
排除标准
- •Pregnant or lactating women
- •Life expectancy < 3 months
- •Serious, uncontrolled, concurrent infection(s)
- •Any prior oxaliplatin or fluoropyrimidine therapy
- •More than one prior chemotherapy regimen for unresectable or metastatic disease
- •Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil or platinum compounds
- •Any active second malignancy
- •Clinically significant cardiac disease or myocardial infarction within the last 12 months
- •Evidence of CNS metastases or history of uncontrolled seizures, central nervous system disorders or psychiatric disability
- •Other serious uncontrolled medical conditions
- •Major surgery within 4 weeks of the start of study treatment, without complete recovery
- •Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
- •Known, existing uncontrolled coagulopathy
研究组 & 干预措施
CAPOX
Participants self-administered capecitabine 1,000 mg/m2 orally twice daily (total daily dose 2,000 mg/m2), days 1-14 in 21-day cycles. Only 500 mg tablets were used, and doses were rounded to the nearest dose that could be administered with 500 mg tablets. Oxaliplatin 130 mg/m2 was administered intravenously on day 1 every 21 (±2) days. Treatment continued until tumor progression or toxicity requiring discontinuation of therapy.
干预措施: Capecitabine (Drug)
CAPOX
Participants self-administered capecitabine 1,000 mg/m2 orally twice daily (total daily dose 2,000 mg/m2), days 1-14 in 21-day cycles. Only 500 mg tablets were used, and doses were rounded to the nearest dose that could be administered with 500 mg tablets. Oxaliplatin 130 mg/m2 was administered intravenously on day 1 every 21 (±2) days. Treatment continued until tumor progression or toxicity requiring discontinuation of therapy.
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
Response Rate
时间窗: Response was assessed by computed tomography (CT) or magnetic resonance imaging (MRI) every two cycles (42 days ±2 days) on treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX.
Response rate (RR) is defined as the proportion of participants achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
次要结局
- Overall Survival(Participants were followed long-term for survival every 3 months from the end of treatment until death or lost to follow-up. Median survival follow-up was 10.8 months (95% CI: 7.1-37.7) in this study cohort.)
- Best Response(Response was assessed by computed tomography (CT) or magnetic resonance imaging (MRI) every two cycles (42 days ±2 days) on treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX.)
- Progression-Free Survival(Disease evaluations occurred every two cycles (42 days ±2 days) on treatment. In this study cohort, participants were followed for progression up to 38 months.)
研究者
Rebecca Miksad, MD, MPH
Assistant Professor, Harvard University; Attending Physician, Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute