colo-rectal cancer
Conditions
Interventions
Capevitabine plus Bevacizumab therapy day1 : bevacizumab d.i.v. day1 to 15 : Capecitabine p.o. day16 to 21 : Capecitabine rest repeat every 21 days
Sponsors
Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) histologically proven colon cancer or rectal cancer 2) with mesurable lesions for RECIST criteria 3) without any chemotherapy berore (eligible if fluoro-pyrimidine treatment has completed more than 6 months before) 4) An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2 5) rest period from former therapy a) more than 4 weeks from an organ resection surgery b) more than 4 weeks from hormone therapy or immune therapy c) more than 4 weeks from cytocain or BRM therapy 6) without any severe complications and limited in the following data a) neutrophile : 1,500/mm3 <= b) hemoglobin : 9.0g/dl <= c) platelet : 100,000/mm3 <= d) T.bil. : 1.5mg/dl >= e) AST, ALT : within 2.5 times of normal range of the hospital f) creatinine : 1.2mg/dl >= g) creatinine clearance >=30mL/min male : [(140-age) x B.W.(kg)]/[72 x s-creatinine(mg/dl)] female : [(140-age) x B.W(kg) x 0.85]/[0.72 x s-creatinine(mg/dl)] 7) patients expected more than 8 weeks survival 8) with written Informed Consent 9) age : Group E : >= 76 years old Group ID : >= 65 years old and with difficulty on intensive chemotherapy due to history of radiation therapy for the pelvic lesions, s-albumin lower than 3.5g/dl and/or doctors decision not to register to the other chemotherapy from intolerance to adverse events
Exclusion criteria
Exclusion criteria: 1) with symptoms due to brain metastatis 2) with uncontrolable diarrhea 3) with difficulty on oral intake due to intestinal paralysis or obstruction 4) with infections diseases or febrile condition 5) with severe pulmonary diseases (interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema etc) 6) with severe diseases (uncontrollable DM, heart failure severe than NYHA lll, renal failure, and/or hepatic failure) 7) pregnant and/or nursing women, or women who expect pregnancy 8) with metastatic meningitis, uncontrollable convulsion, and/or mental disorder 9) with a grade 3 neural disorder 10) with a condition intlerance to medicines in this regimen 11) with a history of grade 3 allergy against Capecitabine 12) with a history of some chemotherapy and/or therapy including a VEGF antagonist 13) with a history of embolism, brain infraction (except Lacuna infraction) or pulmonary infraction 14) under easy bleeding condition due to some diseases or medicines (except low dose aspirin) 15) with a history of thoracic surgery of abdominal surgery 28 days ago 16) with active wounds except reservoir surgery 17) with a history of bloody spit more than 2.5ml 18) any other patient whom the physician in charge of the study judges to be unsuitable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Response Rate(RECIST) Disease controle rate Overall survival Adverse effect | — |
Countries
Japan
Contacts
Public ContactHiroshi Furukawa
Kinki University School of Medicine Department of surgery
Outcome results
None listed