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Bevacizumab, Oxaliplatin, and Docetaxel in Treating Patients With Locally Advanced Unresectable or Metastatic Stomach or Gastroesophageal Junction Cancer

2019年3月13日 更新者：Philip Philip、Barbara Ann Karmanos Cancer Institute

Phase II Trial of Bevacizumab, Docetaxel, and Oxaliplatin in Gastric and Gastroesophageal Junction Cancer

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as oxaliplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with oxaliplatin and docetaxel may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving bevacizumab together with oxaliplatin and docetaxel works in treating patients with locally advanced unresectable or metastatic stomach or gastroesophageal junction cancer.

研究概览

地位

完全的

条件

干预/治疗

详细说明

OBJECTIVES:

Primary

  • Determine the time to progression in patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma treated with bevacizumab, oxaliplatin, and docetaxel.

Secondary

  • Determine the response rate in patients treated with this regimen.
  • Determine the toxic effects of this regimen in these patients.
  • Determine time to treatment failure and overall survival of patients treated with this regimen.
  • Determine the changes in general and disease-specific quality of life, in terms of response to treatment, in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 120 minutes, and docetaxel IV over 60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses beyond CR.

After completion of study treatment, patients are followed periodically for up to 2 years.

PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study within 18-23 months.

研究类型

介入性

注册 (实际的)

39

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Michigan
      • Ann Arbor、Michigan、美国、48109-0942
        • University Of Michigan Comprehensive Cancer Center
      • Detroit、Michigan、美国、48201-1379
        • Barbara Ann Karmanos Cancer Institute
      • Detroit、Michigan、美国、48201
        • Veterans Affairs Medical Center - Detroit
    • Ohio
      • Columbus、Ohio、美国、43210-1240
        • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 120年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

DISEASE CHARACTERISTICS:

  • Histologically confirmed gastric or gastroesophageal junction adenocarcinoma

    • Locally advanced unresectable or metastatic disease

  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10mm by spiral CT scan

    • Bone metastases, ascites, or pleural effusions are not considered measurable disease
    • Evaluable disease must be present outside previously irradiated field
  • No CNS or brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • SWOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10 mg/dL
  • No evidence of bleeding diathesis or coagulopathy

Hepatic

  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Bilirubin ≤ ULN
  • INR < 1.5

Renal

  • Creatinine < 2.0 mg/dL
  • Urine protein:creatinine ratio < 1.0

Cardiovascular

  • No history of deep venous thrombosis requiring anticoagulation
  • No active angina
  • No myocardial infarction within the past year
  • No cerebrovascular accident within the past year
  • No uncontrolled hypertension (systolic blood pressure [BP] > 170 mm Hg and/or diastolic BP > 100 mm Hg) despite medical management

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of study treatment
  • No peripheral neuropathy > grade 1
  • No history of allergy to any of the study drugs or drugs formulated with polysorbate 80
  • No known HIV infection
  • No active peptic ulcer disease
  • No serious non-healing wound, ulcer, or bone fracture
  • No unresolved bacterial infection requiring antibiotics
  • No other active malignancy within the past 3 years except for cancers that have been treated with a curative intent

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent immunotherapy

Chemotherapy

  • No prior chemotherapy for gastric cancer unless disease relapsed > 6 months after completion of non-taxane adjuvant chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • At least 3 weeks since radiotherapy

Surgery

  • At least 4 weeks since prior surgery or open biopsy (except indwelling venous catheter placement)
  • No concurrent surgery

Other

  • At least 4 weeks since prior and no concurrent participation in another experimental drug trial
  • No concurrent full-dose anticoagulation
  • No concurrent experimental drugs

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Docetaxel, Oxaliplatin & Bevacizumab
Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.
生物：Bevacizumab
Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.
其他名称：
  • 阿瓦斯汀
药品：Docetaxel
Must be administered 2nd after Bevacizumab and followed by Oxaliplatin.70 mg/m(2), IV over 60 minutes, day 1 of each cycle;
其他名称：
  • 泰索帝
药品：Oxaliplatin
Must be administered 3rd after Bevacizumab and Docetaxel. 75 mg/m(2), IV over 120 minutes, Day 1 of each cycle.
其他名称：
  • 依洛沙丁

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Time to Progression
大体时间：After every 2 cycles (1 cycle =21 days) From study registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
After every 2 cycles (1 cycle =21 days) From study registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months

次要结果测量

结果测量
措施说明
大体时间
Response Rate by RECIST Criteria
大体时间：After every 2 cycles (1 cycle =21 days)
Percentage of Participants with response by RECIST criteria until progression
After every 2 cycles (1 cycle =21 days)
Toxicity Profile
大体时间：At 21 days following completion of study treatment
Toxicity profile of grade 3 and grade 4 events using the NCI-CTCAE Version 3.0 scale for toxicity grading.
At 21 days following completion of study treatment
Time to Treatment Failure
大体时间：Every 21 days From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Time to treatment failure using the Kaplan-Meier method
Every 21 days From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Overall Survival
大体时间：Patients will be followed for survival every three months after they are off study or until their disease progresses, for up to two years
Overall survival using the Kaplan-Meier method
Patients will be followed for survival every three months after they are off study or until their disease progresses, for up to two years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Barbara Ann Karmanos Cancer Institute

合作者

National Cancer Institute (NCI)

调查人员

  • 首席研究员：Philip A. Philip, MD, PhD, FRCP、Barbara Ann Karmanos Cancer Institute
  • 首席研究员：Basil El-Rayes, MD、Barbara Ann Karmanos Cancer Institute

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2004年10月1日

初级完成 (实际的)

2012年11月1日

研究完成 (实际的)

2013年1月1日

研究注册日期

首次提交

2005年9月20日

首先提交符合 QC 标准的

2005年9月20日

首次发布 (估计)

2005年9月22日

研究记录更新

最后更新发布 (实际的)

2019年3月26日

上次提交的符合 QC 标准的更新

2019年3月13日

最后验证

2019年3月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CDR0000441641
  • P30CA022453 (美国 NIH 拨款/合同)
  • WSU-D-2840
  • UMCC-2005-052
  • AVENTIS-WSU-D-2840

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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