A Phase II Trial of Single Agent Axitinib as Maintenance Therapy for Patients With First Line Metastatic Colorectal Cancer (mCRC)

SCRI Development Innovations, LLC12 个研究点分布在 1 个国家目标入组 70 人开始时间: 2012年1月最近更新: 2019年9月24日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: SCRI Development Innovations, LLC
入组人数: 70
试验地点: 12
主要终点: Progression-free Survival

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a non-randomized, open-label, Phase II trial investigating axitinib as a single-agent maintenance therapy following standard first-line FOLFOX/bevacizumab therapy for patients with mCRC.

详细描述

All patients will receive FOLFOX/bevacizumab for four 28-day cycles (a total of 16 weeks). After 4 cycles, maintenance axitinib will be started. With approval of the Medical Monitor,patients who are having significant benefit from FOLFOX/bevacizumab may continue chemotherapy to a maximum of six 28-day cycles. During trial treatment, all patients will be assessed for response every 8 weeks (2 cycles).

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

•Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum.
•Patients must have measurable disease per RECIST Version 1.
•No previous systemic therapy for metastatic colorectal cancer. Previous radiosensitizing chemotherapy is allowed, if completed at least 4 weeks prior to Cycle 1 Day 1 of study treatment, and previous neoadjuvant and/or adjuvant chemotherapy is allowed, if completed at least 6 months prior to diagnosis of metastatic disease.
•Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to
•Life expectancy >=12 weeks.
•Adequate hematologic, renal and hepatic function
•Patients who are on coumadin should have an INR value within the therapeutic range (i.e., 2 to 3 x ULN). Patients who are on stable, chronic doses of coumadin are eligible.
•Male patients willing to use adequate contraceptive measures. Female patients who are not of child-bearing potential, and female patients of child-bearing potential who agree to use adequate contraceptive measures, who are not breastfeeding, and who have a negative serum or urine pregnancy test performed within 72 hours prior to start of treatment.
•Willingness and ability to comply with the trial and follow-up procedures.
•Ability to understand the investigative nature of this trial and give written informed consent.

排除标准

•History or known presence of central nervous system (CNS) metastases.
•Patients who have had a major surgical procedure (not including mediastinoscopy), or significant traumatic injury <=4 weeks prior to beginning treatment.
•Women who are pregnant or lactating. All females of child-bearing potential must have negative serum or urine pregnancy tests within 72 hours prior to study treatment (see Appendix D)
•History of hypersensitivity to active or inactive excipients of any component of treatment (5 fluorouracil, bevacizumab, oxaliplatin, or axitinib), or known dipyrimidine dehydrogenase deficiency.
•Patients with proteinuria at screening as demonstrated by:
•Urine dipstick for proteinuria >=2+ (patients discovered to have >=2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection, and must demonstrate <=1 g of protein/24 hours to be eligible)
•Patients with a serious non healing wound, active ulcer, or untreated bone fracture.
•Patients with evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).
•Patients with history of hematemesis or hemoptysis (defined as having bright red blood of ½ teaspoon or more per episode) <=1 month prior to study enrollment.
•Patients requiring concomitant treatment with potent CYP3A4 or CYP1A2 inducers and CYP3A4 inhibitors.
•History of myocardial infarction or unstable angina <=6 months prior to beginning treatment.
•Inadequately controlled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg while on antihypertensive medications). Initiation of antihypertensive agents is permitted provided adequate control is documented at least 1 week prior to Day 1 of study treatment.
•New York Heart Association Grade II or greater congestive heart failure.
•Serious cardiac arrhythmia requiring medication. Patients with chronic, rate-controlled atrial fibrillation are eligible.
•Significant vascular disease (e.g., aortic aneurysm requiring surgical repair, or recent peripheral arterial thrombosis) <=6 months prior to Day 1 of treatment.
•History of stroke or transient ischemic attack <=6 months prior to beginning treatment.
•Any prior history of hypertensive crisis or hypertensive encephalopathy.
•History of abdominal fistula or gastrointestinal perforation <=6 months prior to Day 1 of beginning treatment.
•Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
•Any known positive test for human immunodeficiency virus, hepatitis C virus or acute or chronic hepatitis B infection.
•Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.
•Use of any non-approved or investigational agent <=28 days prior to administration of the first dose of study drug. Patients may not receive any other investigational or anti-cancer treatments while participating in this study.
•Past or current history of neoplasm other than the entry diagnosis with the exception of treated non-melanoma skin cancer or carcinoma in situ of the cervix, or other cancers cured by local therapy alone and a disease free survival >=5 years.
•Infection requiring IV antibiotics.
•Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter drug absorption (e.g. active inflammatory bowel disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or significant small bowel resection).
•Inability to swallow whole tablets.
•Patients with > Grade 2 peripheral neuropathy.

研究组 & 干预措施

FOLFOX/bevacizumab and Axitinib

Experimental

Phase II trial investigating axitinib as a single-agent maintenance therapy following standard first-line FOLFOX/bevacizumab therapy for patients with mCRC. (FOLFOX is a combination of 5-Fluorouracil, Leucovorin and Oxaliplatin.)