NL-OMON39414已完成2 期
Phase II Study of Docetaxel, Oxaliplatin, Capecitabine with Bevacizumab and Trastuzumab in case of human epidermal growth factor receptor 2 (HER2)-positivity in Patients with Locally Advanced or Metastatic Gastric Cancer or Adenocarcinoma of the Gastro-oesophageal Junction (B-DOCT study) - B-DOCT study
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 90 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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/evaluable 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. Assessment of HER2 status (primary tumour or metastasis) by the central laboratory prior to initiation of study treatment (Dual SISH, Ventana).
- •7. LVEF >= 50% assessed by multigated radionucleotide angiography (MUGA) or cardiac ultrasound.
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. Patients with increased risk of gastro-intestinal perforation in response to treatment due to deep ulceration of the tumour through the wall of the distal oesophagus and/or stomach, as assessed by endoscopy.
- •3. Previous radiotherapy on the abdomen
- •4. Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma
- •5. Patients with active (significant or uncontrolled) gastrointestinal bleeding
- •6. Residual relevant toxicity resulting from previous therapy (with the exception of alopecia), e.g. neurological toxicity >= grade 2 NCI-CTCAE
- •7. Creatinin clearance <50 mL/min
- •8. Neutrophil count <1.5 × 109/L, or platelet count <100 × 109/L
- •9. 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
- •10. Known dihydropyrimidine dehydrogenase (DPD) deficiency.
- •11. 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.
- •12. Patients with dyspnoea at rest due to complications of advanced malignancy or other disease, or who require supportive oxygen therapy.
- •13. 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)
- •14. Major surgery within 4 weeks of start of study treatment,
- •15. Known hypersensitivity to any of the study drugs
- •16. History or clinical evidence of brain metastases
- •17. Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes
- •18. Positive serum pregnancy test in women with childbearing potential
- •19. Subjects with reproductive potential not willing to use an effective method of contraception
- •20. Any investigational drug treatment within 4 weeks of start of study treatment
- •21. 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)
- •22. Therapeutic use of oral coumarin-derived or LMWH anticoagulants or NSAIDs.
- •23. Continuous use of immunosuppressive agents (for the use of corticosteroids see #12).
研究者
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