A Multicenter, Open-Label, Phase II Study of Irinotecan, Cisplatin, and Bevacizumab in Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Time to progression, evaluated using RECIST
研究概览
简要总结
This phase II trial is studying how well giving irinotecan and cisplatin together with bevacizumab works in treating patients with unresectable or metastatic gastric (stomach) or gastroesophageal junction adenocarcinoma (cancer). Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Giving chemotherapy together with a monoclonal antibody may kill more tumor cells.
详细描述
PRIMARY OBJECTIVES:
I. Determine the efficacy of irinotecan, cisplatin, and bevacizumab, in terms of time to progression, in patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
SECONDARY OBJECTIVES:
I. Determine other measures of efficacy, including response rate and median and 1-year survival, in patients treated with this regimen.
II. Determine the toxicity of this regimen in these patients. III. Correlate CT perfusion imaging results with the efficacy of this regimen, in terms of time to progression, objective response, and survival, in these patients.
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
- •Histologically or cytologically confirmed gastric or gastroesophageal junction (GEJ) adenocarcinoma
- •Metastatic or unresectable disease
- •Siewert's classification I, II, or III
- •No ulcerated, non-healing tumors or tumors that have developed a malignant fistula
- •No esophageal tumors
- •No known or active brain metastases
- •Performance status - Karnofsky 60-100%
- •Performance status - ECOG 0-2
- •Neutrophil count >= 1,500/mm^3
- •Platelet count >= 75,000/mm^3
- •No bleeding diathesis or coagulopathy
- •Bilirubin =< 1.5 mg/dL
- •AST and ALT =< 3 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
- •PT (INR) =< 1.5
- •PTT =< 3 seconds above ULN
- •Creatinine =< 1.5 mg/dL
- •Proteinuria < 1+
- •Protein < 500 mg/24-hour urine collection
- •No acute ischemia or significant conduction abnormality by EKG
- •No clinically significant cardiovascular disease
- •No uncontrolled hypertension (blood pressure > 160/90 mm Hg on medication)
- •No myocardial infarction within the past 6 months
- •No unstable angina within the past 6 months
- •No transient ischemic attack within the past 6 months
- •No cerebrovascular accident within the past 6 months
- •No other arterial thromboembolic event within the past 6 months
- •No New York Heart Association class II-IV congestive heart failure
- •No serious cardiac dysrhythmia requiring medication
- •No peripheral vascular disease (grade II or greater)
- •No history of stroke
- •No CNS disease within the past 5 years (e.g., uncontrolled seizures)
- •No other concurrent uncontrolled illness
- •No ongoing or active infection requiring parental antibiotics on Day 0 of study
- •No serious, non-healing wound
- •No serious wound healing by secondary intention
- •No bone fracture
- •No psychiatric illness or social situation that would preclude study compliance
- •No significant traumatic injury within the past 28 days
- •No other neoplastic disease within the past 3 years except basal cell skin cancer, carcinoma in situ of the cervix, or nonmetastatic prostate cancer
- •No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
- •No other medical condition that would preclude study participation
- •Not pregnant or nursing
- •No nursing during and for 4 months after study participation
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 4 months after study participation
- •More than 8 weeks since prior immunotherapy and recovered
- •No other concurrent biologic or immunologic agents
- •No other concurrent bevacizumab
- •No prior chemotherapy for metastatic disease
- •No prior cisplatin or irinotecan
- 另有 18 项未显示
排除标准
- 未提供
研究组 & 干预措施
Treatment (bevacizumab, cisplatin, irinotecan)
Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: irinotecan hydrochloride (Drug)
Treatment (bevacizumab, cisplatin, irinotecan)
Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: bevacizumab (Biological)
Treatment (bevacizumab, cisplatin, irinotecan)
Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: cisplatin (Drug)
Treatment (bevacizumab, cisplatin, irinotecan)
Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: computed tomography (Procedure)
Treatment (bevacizumab, cisplatin, irinotecan)
Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1 and 8. Courses repeat every 21 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
Time to progression, evaluated using RECIST
时间窗: Up to 1 year
Kaplan-Meier estimates will be used.
次要结局
- Incidence of toxicity, evaluated using CTCAE version 3.0(Up to 1 year)
- Overall response rate, evaluated using RECIST(Up to 1 year)
- Complete response rate, evaluated using RECIST(Up to 1 year)
- Duration of response, evaluated using RECIST(From the time measurement criteria are met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 1 year)
- Survival(Up to 1 year)