A Phase II Study Trastuzumab (NSC 688097) in Her2/Neu Positive Cancer of the Gallbladder or Biliary Tract (NCI 7756)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Objective Response (Complete and Partial Response)
研究概览
简要总结
This phase II trial is studying how well trastuzumab works in treating patients with locally advanced or metastatic gallbladder cancer or bile duct cancer that cannot be removed by surgery. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them
详细描述
PRIMARY OBJECTIVE:
I. Determine the objective response rate and duration of objective response in patients with HER2/neu-positive advanced gallbladder or biliary tract cancer treated with trastuzumab (Herceptin).
SECONDARY OBJECTIVES:
I. Assess the safety and tolerability of this drug in these patients. II. Assess the progression-free survival and overall survival of patients treated with this drug.
OUTLINE:
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
- •Adenocarcinoma of the gallbladder
- •Recurrent extrahepatic bile duct cancer
- •Recurrent gallbladder cancer
- •Unresectable extrahepatic bile duct cancer
- •Adenocarcinoma of the extrahepatic bile duct
- •Unresectable gallbladder cancer
- •Prior surgery and radiotherapy allowed
- •At least 28 days since prior chemotherapy (6 weeks for nitrosoureas and mitomycin C) and recovered
- •No other concurrent investigational agents, chemotherapy, radiotherapy, or hormonal therapy
- •Concurrent hormones administered for nondisease-related conditions (e.g., insulin for diabetes) allowed
- •No concurrent corticosteroids or anticonvulsants
- •Concurrent steroids administered for antiemesis, adrenal failure, or septic shock allowed
- •No concurrent combination antiretroviral therapy for HIV-positive patients
- •Histologically or cytologically confirmed adenocarcinoma of the gallbladder or bile duct, meeting all of the following criteria: locally advanced or metastatic disease that is unresectable
- •Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques or >= 10 mm by spiral computed tomography (CT) scan
- •Tumor that recurs within a previously irradiated field is considered measurable disease if recurrence is documented and measurable by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- •Tumor must be Her2/neu positive by Fluorescence in situ hybridization (FISH)testing
- •No symptomatic brain metastases
- •The Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 OR Karnofsky PS 60-100%
- •Absolute neutrophil count (ANC) >= 1,500/mm^3
- •Fertile patients must use effective contraception prior to, during, and for >= 3 months after completion of study treatment
- •Creatinine =< 2 times upper limits of normal (ULN) OR creatinine clearance >= 60 mL/min
- •No other active malignancy
- •Left Ventricular Ejection Fraction (LVEF) >= 50%
- •No concurrent uncontrolled illness
- •No ongoing or active infection requiring systemic IV antibiotics on day 1 of treatment
- •No symptomatic New York Heart Association class III-IV congestive heart failure
- •No unstable angina pectoris
- •No unstable cardiac arrhythmia requiring medication
- •No more than 1 prior systemic chemotherapy regimen
- •White Blood Count (WBC) >= 3,000/mm^3
- •Platelet count >= 40,000/mm^3
- •Bilirubin =< 4 mg/dL
- •Aspartate aminotransferase and alanine aminotransferase (AST and ALT) =< 5 times upper limit of normal (ULN)
- •Not pregnant or nursing
- •Negative pregnancy test
排除标准
- 未提供
研究组 & 干预措施
Trastuzumab
Participants receive trastuzumab loading dose 8 mg/kg intravenous (IV) over 30-90 minutes on day 1 and subsequent maintenance doses of 6 mg/kg over 90 minutes then every 30 minutes starting at the third dose. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
Trastuzumab
Participants receive trastuzumab loading dose 8 mg/kg intravenous (IV) over 30-90 minutes on day 1 and subsequent maintenance doses of 6 mg/kg over 90 minutes then every 30 minutes starting at the third dose. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: trastuzumab (Biological)
结局指标
主要结局
Objective Response (Complete and Partial Response)
时间窗: Baseline to 63 days or until disease progression
Response assessed using imaging-based evaluation at baseline then following single agent trastuzumab administered over 21 day cycle, re-staging done following 2 cycles. Response Evaluation Criteria in Solid Tumors defined as Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
次要结局
- Disease Control Rate(Up to 3.5 years)
- Overall Survival(Up to 3.5 years)
- Number of Participant With Toxicity Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0(Up to 3 years)