Phase II Study of the Combination of Cetuximab, Capecitabine, and Oxaliplatin With Out Without Bevacizumab as Initial Therapy for Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
The purpose of this study is to determine the objective response rate of patients with previously untreated metastatic colorectal cancer treated with the combination of cetuximab, capecitabine, and oxaliplatin with out without bevacizumab.
详细描述
Research has shown that the more drug treatments patients with cancer of the colon or rectum receive, the longer they live. One uses the drugs capecitabine and oxaliplatin which all patients on this study will receive. Bevacizumab is an antibody which blocks blood flow to tumors and increases how long patients with colorectal cancer live. However, it can increase the risk of stroke and heart attack. Bevacizumab is currently a standard part of treatment for colorectal cancer. Cetuximab is an antibody which blocks a protein called EGFR which shrinks colorectal cancer. It may be helpful with initial chemotherapy and with bevacizumab. One goal of this study is to find out the response rate (chance of tumor shrinking) with two treatments for colorectal cancer. All patients will get capecitabine, oxaliplatin and cetuximab. Half will receive bevacizumab. All drugs in this study are approved to treat colorectal cancer. This research study is being done to find the best, safest way to combine these therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •measurable metastatic adenocarcinoma of the colon or rectum
- •no prior systemic therapy for metastatic disease
- •adjuvant therapy must have been completed >/=12 months prior to recurrence, prior radiotherapy permitted but must have been completed > 6 months prior to study entry
- •must have tumor tissue available for EGFR and thymidine phosphorylase evaluation
- •ECOG PS 0-1
- •age >/= 18
- •adequate organ function: WBC>/=3,000, ANC >/=1,500, platelets>/= 100,000, total bilirubin </= 1.5X ULN, AST&ALT </= 2.5X ULN, create clearance >/= 50mL/min
- •negative pregnancy test w/in 72 hours of treatment for women of child bearing potential
- •ability to understand and willing to sign written ICF
- •able to swallow and absorb oral medication
排除标准
- •medical or psychiatric condition which would potentially pose risk to patient by participation (i.e. but not limited to:uncontrolled hypertension, MI w/in 6 months,CNS disease, pregnancy or nursing)
- •history of neoplasm (other than non-metastatic skin cancer or carcinoma in situ of cervix) w/in 5 years
- •surgical procedure (not including closed biopsy or access port placement), open biopsy, significant traumatic injury w/in 28 days of registration or anticipation of need for surgical procedure while on study, fine needle aspiration or core biopsy w/in 7 days of registration
- •urine protein:creatinine ration >/=1.0 at screening
- •evidence of bleeding diathesis or coagulopathy (in absence of anticoagulation)
- •prior severe infusion reaction to MAB or allergic reaction to capecitabine or oxaliplatin
- •underlying neuropathy >/= grade 2
- •TIA or CVA w/in 6 months
研究组 & 干预措施
Cetuximab, Oxaliplatin, Capecitabine, Bevacizumab
Cetuximab 400 mg/m2 IV initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle; Oxaliplatin 130mg/m2 IV day 1 of each 21 day cycle; Capecitabine 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle; Bevacizumab 7.5mg/kg IV day 1 of each 21 day cycle
干预措施: bevacizumab (Drug)
Cetuximab, Oxaliplatin, Capecitabine, Bevacizumab
Cetuximab 400 mg/m2 IV initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle; Oxaliplatin 130mg/m2 IV day 1 of each 21 day cycle; Capecitabine 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle; Bevacizumab 7.5mg/kg IV day 1 of each 21 day cycle
干预措施: cetuximab (Drug)
Cetuximab, Oxaliplatin, Capecitabine, Bevacizumab
Cetuximab 400 mg/m2 IV initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle; Oxaliplatin 130mg/m2 IV day 1 of each 21 day cycle; Capecitabine 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle; Bevacizumab 7.5mg/kg IV day 1 of each 21 day cycle
干预措施: Oxaliplatin (Drug)
Cetuximab, Oxaliplatin, Capecitabine, Bevacizumab
Cetuximab 400 mg/m2 IV initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle; Oxaliplatin 130mg/m2 IV day 1 of each 21 day cycle; Capecitabine 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle; Bevacizumab 7.5mg/kg IV day 1 of each 21 day cycle
干预措施: Capecitabine (Drug)
Cetuximab, Oxaliplatin, Capecitabine
Cetuximab 400 mg/m2 IV initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle; Oxaliplatin 130mg/m2 IV day 1 of each 21 day cycle; Capecitabine 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle
干预措施: cetuximab (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: every 6-9 weeks; from date of first study drug dose until off treatment date (median of 8 cycles; range <1-19)
Objective response rate calculated by the proportion of overall response: CR+PR. Patients were categorized by one of the following (1-4 per RECISTv1.0 criteria on CT, MRI, x-ray; 4-9 considered failure to respond/disease progression): 1. complete response (CR): Disappearance of all lesions 2. partial response (PR): \>=30% decrease in the sum of the longest diameter of target lesions (SoL); from baseline SoL 3. stable disease (SD): Neither PR, PD, or CR 4. progressive disease (PD): \>=20% increase in the SoL; from smallest SoL. Or appearance of new lesion 5. early death from malignant disease 6. early death from toxicity 7. early death from other cause 9) unknown (not assessable, insufficient data)
次要结局
- Time to Progression (TTP)(every 6-9 weeks; from dose of first study drug to event)
- Overall Survival(From dose of first study drug to last timepoint known to be alive (median follow-up for all patients was 25.9 months))