EUCTR2005-000387-39-GB进行中（未招募）1 期
An open-label randomized multicentre phase III study of trastuzumab in combination with a fluoropyrimidine and cisplatin versus chemotherapy alone as first-line therapy in patients with HER2 positive advanced gastric cancer.
Hoffmann-La Roche Ltd/Inc/AG/Roche Global Development0 个研究点目标入组 584 人开始时间: 2005年6月21日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 584
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
入选标准
- •Disease Specific Inclusion Criteria:
- •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 Tumors (RECIST), or non-measurable evaluable disease, assessed using imaging techniques (CT or MRI).
- •3. HER2 positive tumour (primary tumour or metastasis) as assessed by the central laboratory. (Both IHC and FISH will be performed on all patients in the central laboratory.)
- •4. ECOG Performance status 0, 1 or 2.
- •5. Life expectancy of at least 3 months.
- •General Inclusion Criteria:
- •6. Male or female. Age greater or equal to 18 years.
- •7. Signed informed consent.
- •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
- •Cancer-Related Exclusion Criteria:
- •1. Previous chemotherapy for advanced/metastatic disease (prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study; adjuvant/neoadjuvant therapy with platin is not allowed).
- •2. Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (e.g. patients with partial or total gastrectomy can enter the study, but not those with a jejunostomy probe). This is pertinent to those patients who are to receive capecitabine, in view of capecitabine being an orally administered study drug (whereas 5-FU is given intravenously).
- •3. Patients with active (significant or uncontrolled) gastrointestinal bleeding.
- •4. Residual relevant toxicity resulting from previous therapy (with the exception of alopecia), e.g. neurological toxicity =grade 2 NCI-CTCAE.
- •5. Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma.
- •Haematological, Biochemical and Organ Function:
- •6. Neutrophil count < 1.5 × 109/L, or platelet count < 100 × 109/L.
- •7. 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.
- •8. Creatinine clearance < 60 mL/min.
- •Other Study Drug-Related Exclusion Criteria:
- •9. History of documented congestive heart failure; angina pectoris requiring medication; evidence of transmural myocardial infarction on ECG; poorly controlled hypertension (systolic BP > 180 mmHg or diastolic BP > 100 mmHg); clinically significant valvular heart disease; or high risk uncontrollable arrhythmias.
- •10. Baseline LVEF < 50% (measured by echocardiography or MUGA).
- •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. Clinically significant hearing abnormality.
- •14. Known dihydropyrimidine dehydrogenase (DPD) deficiency.
- •General Exclusion Criteria:
- •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 of childbearing potential.
- •18. Subjects with reproductive potential not willing to use an effective method of contraception.
- •19. Received 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. Major surgery within 4 weeks of start of study treatment, without complete recovery.
- •22. Patients wit
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