Phase II trial of capecitabine + bevacizumab as maintenance treatment after initial treatment with XELOX in previously untreated metastatic colorectal cancer
- Conditions
- advanced colorectal cancer
- Registration Number
- JPRN-UMIN000006111
- Lead Sponsor
- SGCSG: Shimane Gastroenterological Cancer Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Not provided
(1)History of the serious hypersensitivity for Capecitabine, Fluorouracil, Platinum or bevacizumab. History of the serious AE for Capecitabine or Fluorouracil by DPD Deficiency. (2)CNS metastases or brain cancer confirmed by imaging. (3)Cerebrovascular disease or its symptoms within 1 year. History of thromboembolism once within a year. (4)Synchronous malignant coelomic fluid that required drainage. (5)History of active double cancer within 5 years. (6)Necessity for antithrombotic drug. (7)Need tobadministrate or having anti-plateles therapy(including Methotrexate, aspirin and NSAIDS) (8)Symptom of gastrointestinal bleeding, intestinal paralysis, ileus, uncontrolled complication of peptic ulcer. (9)History of gastrointestinal perforation within 1 year. (10)Evidence of traumatic bone fracture. (11)Renal failure to be treated, 2+ or higher proteinuria within 2 weeks prior to entry. (12)Uncontrolled hypertension or diabetes. (13)Patient with symptomatic cardiovascular disease or asymptomatic disease but have been treated (>=Grade 2 according to NCI-CTCAE ver.4). History of myocardial infarction within a year. (14)Evidence of interstitial lung disease or lung fibrosis. (15)Evidence of peripheral sensory neuropathy(>=Grade 1 according to NCI-CTCAE ver.4). (16)Uncontrolled infection. (17)Patient receiving surgical procedure or such as skin-open biopsy, trauma surgery, or other more intensive surgeries within 4 weeks. (18)Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers. (19)Man who doesn't practice birth control. (20)Not appropriate for the study at the physician's assessment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Duration of disease control
- Secondary Outcome Measures
Name Time Method Progression Free Survival,Time to Treatment Failure,Safety,Overall Response Rate,2nd Overall Response Rate,Reintroduction rate of Oxaliplatin,Overall Survival