EUCTR2010-022699-30-NL进行中（未招募）不适用
Phase II Study of Docetaxel, Oxaliplatin, Capecitabine with Bevacizumab and Trastuzumab in case of human epidermal growth factor receptor 2 (HER2)-positivity inPatients with Locally Advanced or Metastatic Gastric Cancer or Adenocarcinoma of the Gastro-oesophageal Junction (B-DOCT study) - B-DOCT study
ederlands Kanker Instutuut-Antonie van Leeuwenhoek Ziekenhuis0 个研究点开始时间: 2010年9月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Histologically confirmed adenocarcinoma of the stomach or gastro-oesophageal junction with inoperable locally advanced or recurrent and/or metastatic disease not amenable to curative therapy.
- •2.Measurable disease, according to the Response Evaluation Criteria in Solid Tumours (RECIST), assessed using imaging techniques (CT or MRI)
- •3.ECOG Performance status 0, 1 or 2
- •4.Life expectancy of at least 3 months
- •5.Male or female age = 18 years
- •6.Signed informed consent
- •7.Assessment of HER2 status (primary tumour or metastasis) by the central laboratory prior to initiation of study treatment (Dual SISH, Ventana).
- •8.Able to swallow and retain oral medication.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Previous chemotherapy for advanced/metastatic disease (prior peri-operative chemotherapy is allowed if at least 6 months has elapsed between completion of this therapy and enrolment into the study)
- •2.Previous radiotherapy on the abdomen
- •3.Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma
- •4.Patients with active (significant or uncontrolled) gastrointestinal bleeding
- •5.Residual relevant toxicity resulting from previous therapy (with the exception of alopecia), e.g. neurological toxicity = grade 2 NCI-CTCAE
- •6.Creatinin clearance <50 mL/min
- •7.Neutrophil count <1.5 × 109/L, or platelet count <100 × 109/L
- •8.Serum bilirubin >1.5 × upper limit of normal (ULN); or, AST or ALT >2.5 × ULN (or > 5 × ULN in patients with liver metastases); or, alkaline phosphatase >2.5 × ULN (or >5 × ULN in patients with liver metastases, or >10 × ULN in patients with bone but no liver metastases); or, albumin <25 g/L
- •9.Known dihydropyrimidine dehydrogenase (DPD) deficiency.
- •10.History of documented congestive heart failure; angina pectoris requiring medication; evidence of transmural myocardial infarction; poorly controlled hypertension (systolic BP >180 mmHg or diastolic BP >100 mmHg); clinically significant valvular heart disease; or high risk uncontrollable arrhythmias.
- •11.Patients with dyspnoea at rest due to complications of advanced malignancy or other disease, or who require supportive oxygen therapy.
- •12.Patients receiving chronic or high dose corticosteroid therapy. (Inhaled steroids and short courses of oral steroids for anti-emesis or as an appetite stimulant are allowed)
- •13.Major surgery within 4 weeks of start of study treatment,
- •14.Known hypersensitivity to any of the study drugs
- •15.History or clinical evidence of brain metastases
- •16.Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes
- •17.Positive serum pregnancy test in women with childbearing potential
- •18.Subjects with reproductive potential not willing to use an effective method of contraception
- •19.Any investigational drug treatment within 4 weeks of start of study treatment
- •20.Radiotherapy within 4 weeks of start of study treatment (2 week interval allowed if palliative radiotherapy given to bone metastastic site peripherally and patient recovered from any acute toxicity)
- •21.Therapeutic use of oral coumarin-derived or LMWH anticoagulants or NSAIDs.
- •22.Continuous use of immunosuppressive agents (for the use of corticosteroids see #12).
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