NCT01531595进行中（未招募）2 期
Phase 2 Study of Bevacizumab in Combination with Alternating XELIRI and XELOX As First-line Treatment of Patients with Metastatic Colorectal Cancer
Pia Osterlund1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Resectability of metastases
研究概览
简要总结
- Open-label, single-arm, phase II study of bevacizumab (AvastinTM) in combination with alternating XELIRI (capecitabine+irinotecan) and XELOX (capecitabine+oxaliplatin) as first-line treatment of patients with metastatic colorectal cancer.
- Primary objective: Progression Free Survival (PFS),
- To assess overall resectability in patients with metastatic colorectal cancer, postoperative morbidity and outcomes after resection.
- Secondary objectives: To assess response rates according to RECIST criteria, failure free survival (TTF) and overall survival (OS), Quality of life according to 15-dimensional instrument (15D) questionnaire, To radiologically assess tumour density and morphology, and assess alternative radiologic response evaluation in comparison with RECIST response criteria, Biomarker evaluation to measure plasma biomarkers, tumour blocks and DNA polymorphisms that may predict drug effects, safety, resectability and clinical behaviour of the tumour
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 with histologically confirmed diagnosis of colorectal cancer (CRC), chemotherapy naïve for metastatic disease (prior adjuvant chemotherapy more than 6 months previously for CRC allowed), who are scheduled to start first line chemotherapy for metastatic disease
- •Measurable or evaluable metastatic disease
- •Performance status Eastern co-operative oncology group (ECOG) performance status 0-2
- •Life expectancy greater than 3 months
- •Normal Thrombocytes, neutrophils, Aspartate amino transferase/Alanine amino transferase, Alkaline phosphatase, Serum bilirubin, Serum Creatinine, Urine dipstick of proteinuria.
- •Women of childbearing potential must have a negative serum pregnancy test done prior to the administration of bevacizumab. Patient and their partner should have adequate contraception up to at least 6 months after last treatment completion or the last drug dose, whatever happens first
- •Signed written informed consent according to international council for harmonization (ICH)/Good clinical practice (GCP) and the local regulations (approved by the Independent Ethics Committee (IEC)) will be obtained prior to any study specific screening procedures
- •Patient must be able to comply with the protocol
排除标准
- •Prior treatment with first-line chemotherapy for metastatic CRC
- •Adjuvant treatment within 6 months
- •Major surgical procedure (placing of central venous access device and liver biopsy etc are considered minor procedure), open biopsy or significant traumatic injury within 28 days prior to Day 0 (Patients must have recovered from any major surgery)
- •Near future planned radiotherapy for underlying disease (prior completed radiotherapy treatment allowed)
- •Clinical or radiological evidence of central nervous system (CNS) metastases
- •Past or current history within the last 2 years of malignancies except for the indication under this study and curatively treated basal and squamous cell carcinoma of the skin or in-situ carcinoma of the cervix
- •Serious non-healing wound or ulcer
- •Evidence of bleeding diathesis or coagulopathy
- •Uncontrolled hypertension
- •Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (≤ 6 months), myocardial infarction (≤ 6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication
- •Treatment with any investigational drug within 30 days prior to enrolment
- •Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the treatment or patient at high risk from treatment complications
- •Chronic daily intake of aspirin (> 325 mg/day) or clopidogrel (> 75 mg/day)
- •Pregnancy (positive serum pregnancy test) and lactation
- •Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial
研究组 & 干预措施
Chemotherapy plus bevacizumab
Experimental
Bevacizumab plus alternating XELOX x3 cycles (capecitabine + oxaliplatin) and XELIRI x3 cycles (capecitabine + irinotecan)
干预措施: Bevacizumab plus alternating XELOX/XELIRI (Drug)
结局指标
主要结局
Resectability of metastases
时间窗: 5 years
To evaluate technical resectability rate of colorectal cancer metastasis after conversion therapy
Efficacy of alternating therapy
时间窗: 5 years
Progression free survival rate at 12 months
次要结局
- Response of alternating therapy(5 years)
- Efficacy of treatment(5 years)
- Progression-free survival(5 years)
- Translational research(10 years)
研究者
Pia Osterlund
Principal Investigator
Helsinki University Central Hospital
研究点 (1)
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