advanced and/or recurrent colorectal cancer
Conditions
Interventions
XELIRI plus bevacizumab therapy Capecitabine: 2000 mg/m2 day1 to 8 CPT11 150mg/m2 day1 Bevacizumab: 10mg/kg day 1 The treatment is repeated every two weeks until disease progression or severe to
Sponsors
NPO Japan Southwest Oncology Research Support Organization(JSWOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Written informed consent after the explanation of the content of the examination (2) Age of 20 years or elder (3) ECOG performance status of 0 and 1 (4) Life expectancy more than 3 months (5) Histopathologically confirmed colorectal cancer (6) Measurable or evaluable disease (RECIST ver.1.1) (7) Metastatic colorectal cancer which has prior therapy of Oxalipalatin based chemotherapy (8) Adequate organ functions
Exclusion criteria
Exclusion criteria: (1) Massive pleural effusion or ascites that required drainage (2) Severe liver disease (3) Severe renal function disorder, 2+ or higher proteinuria within 2 weeks prior to enrollment (4) Severe renal failure (5) Metastases to the CNS (6) History of active double cancer within 5 years (7) Complication of cerebrovascular disease or symptoms within 1 year (8) Patient receiving surgical procedure or such as skin-open biopsy, trauma surgery, or other more intensive surgeries within 4 weeks or aspiration biopsy within a week (9) Radiation therapy within 4 weeks before enrollment (10) Administering antithrombotic drug within 10 days before enrollment (11) bleeding diathesis or receiving anticoagulant drug(except Aspirin under 325mg/day) (12) A bleeding tendency, coagulation disorder or abnormal coagulation factor (13) Uncontrollable peptic ulcer (14) History of gastrointestinal perforation within 1 year. (15) Patient with untreated traumatic bone fracture (16) Uncontrollable hypertension (17) Serious heart disease (18) History of severe allergy with 5-FU (19) Uncontrollable diarrhea (20) Interstitial pneumonitis (21) Inability of oral Agent intake (22) Requiring novel immunosuppressant and steroid (23) Receiving atazanavir sulfate (24) Severe infection disease (25) Treatment history of CPT-11 (26) Other conditions not suitable for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival and safety | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival,time to progression, and safety,Response rate,Dose Intensity,and Analysis of the safety and efficacy of CPT-11-containing regimens based on genetic polymorphisms UGT1As | — |
Countries
Japan
Contacts
Public ContactShoichi Hazama
YAMAGUCHI UNIVERSITY GRADUATE SCHOOL OF MEDICINE Digestive surgery and surgical oncology
Outcome results
None listed