NCT01007552已完成2 期
A Multicenter Phase II Study of Gemcitabine, Capecitabine and Bevacizumab for Locally Advanced or Metastatic Adenocarcinoma of the Gall Bladder or Biliary Ducts.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The Primary Objective of This Study is to Assess Progression Free Survival (PFS) With Proposed Therapy for Patients With Locally Advanced or Metastatic Gallbladder and Biliary Cancers.
研究概览
简要总结
To assess the proposed therapy for patients with advanced gallbladder or biliary cancers.
详细描述
The primary objective of this study is to assess progression free survival with proposed therapy for patients with locally advanced or metastatic adenocarcinoma of the gallbladder or biliary ducts.
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 or cytologically confirmed gallbladder or biliary tract adenocarcinoma that is unresectable or metastatic, or metastatic adenocarcinoma which is radiologically confirmed to be of gallbladder or biliary origin. No prior systemic therapy for metastatic disease. Prior adjuvant therapy is permitted if completed over 6months ago.
- •Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of bevacizumab in combination with gemcitabine in patients over 18 years of age, children are excluded from this study, but will be eligible for future pediatric phase 1 combination trials.
- •ECOG performance status 0 or
- •Life expectancy > 3 months.
- •Patients must have normal organ and marrow function as defined below:
- •leukocytes ≥ 3,000/microL
- •absolute neutrophil count ≥ 1,500/microL
- •platelets ≥ 1OO,OOO/microL
- •total bilirubin ≤ 2 mg/dl
- •AST or ALT ≤ 5 times upper limit of normal (UNL) for subjects with documented liver metastases; ≤ 2.5 times UNL for subjects without evidence of liver metastases.
- •creatinine < 1.5 mg/dL or 24 hour urine creatinine clearance > 50 ml/min.
- •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.
- •Signed, written informed consent document.
- •Patient must have measurable disease
排除标准
- •Subjects meeting any of the following criteria are ineligible for study entry:
- •Compromised renal or hepatic function.
- •Screening clinical laboratory values INR ≥ 1.5 (except those subjects who are receiving full-dose warfarin)
- •Hemoglobin < 9 gm/dL (may be transfused or receive epoetin alfa (e.g., Epogen@) to maintain or exceed this level).
- •Bevacizumab risk factors: History of serious systemic disease, including uncontrolled hypertension (blood pressure of greater than 160/110 mmHg on medication), prior history of hypertensive crisis or hypertensive encephalopathy, unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure, unstable symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible), or clinically significant peripheral vascular disease (Grade II or greater).
- •Presence of central nervous system or brain metastases.
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study; fine needle aspirations or core biopsies within 7 days prior to Day O.
- •Pregnancy (positive pregnancy test) or lactation.
- •24 hour urine creatinine clearance < 50 ml/min or urine protein/creatinine ratio greater than or equal to 1.0 at screening.
- •Serious, nonhealing wound, ulcer, or bone fracture.
- •Evidence of bleeding diathesis or coagu1opathy.
- •Recent (less than or equal to six months) arterial thromboembolic events, including transient ischemic attack (TIA), cerebrovascular accident (CVA), unstable angina, or myocardial infarction (MI).
- •Inability to comply with study and/or follow-up procedures.
- •Patients with known duodenal or gastric wall involvement should be excluded.
- •Patients with suspected involvement of stomach or duodenum should have screening endoscopies to exclude the same prior to therapy.
- •Patients with esophageal or gastric varices.
- •Patients with recent hemoptysis (within 1 week).
研究组 & 干预措施
Gemcitabine, Capecitabine and Bevacizumab
Experimental
Estimate the toxicity of the regimen, and estimate the quality of life (QOL).
干预措施: Gemcitabine, Capecitabine and Bevacizumab (Drug)
结局指标
主要结局
The Primary Objective of This Study is to Assess Progression Free Survival (PFS) With Proposed Therapy for Patients With Locally Advanced or Metastatic Gallbladder and Biliary Cancers.
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST 1.0). Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. Note: Lesions are either measurable or non-measurable using the criteria provided below. The term "evaluable" in reference to measurability will not be used because it does not provide additional meaning or accuracy.
次要结局
- Assess the Toxicity of the Regimen.(up to 5 years)
- Estimate the Proportion of Patients With Clinical Response(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)
- Assess the Change in the Quality of Life Among Patients Using the FACT-Hep (Version 4) for Hepatobiliary Cancers.(Baseline, Day 22 and Day 43)
- Assess Overall Survival (OS)(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)
- Circulating Tumor Cells (CTC) Will be Assessed at Baseline, Day 22 and Day 43(baseline, day 22 and day 43)
- Collect Samples at Baseline, Day 8 and Day 43 for Future Biomarker Studies and Development of Profiles of Responders to Anti-VEGF Therapy (Optional)(Baseline, day 8 and day 43)
研究者
研究点 (2)
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