Patients with advanced or recurrent colorectal cancer after failure to irinotecan.
Conditions
Interventions
Capecitabine plus oxaliplatin (XELOX) in combination with Bevacizumab. Capecitabine:2000mg/m2/day p.o.(day1-15) Oxaliplatin:130mg/m2 i.v.(day1) Bevacizumab:7.5mg/kg i.v.(day1) to be repeated e
Sponsors
Department of Surgery, School of Medicine, Keio University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Histological confirmation of colorectal cancer. (2) Unresectable primary tumor or with one or more unresectable metastatic tumor. (3) 20 years old or more when received informed consent. (4) Eastern Cooperative Oncology Group (ECOG) performance status (PS):0 - 2. (5) With estimative lesion observed in imaging or intraoperation within 28 days before registration. (measurable lesions in RECIST criteria (ver.1.1)is despensable) (6) Withdrawal from first-line chemotherapy due to toxicity or progressive disease (7)Patients with metastatic colorectal cancer who had previously received first-line therapy with an irinotecan-based regimen. (8) No previous treatment with Oxaliplatin contained regimen. (9) Life expectancy estimated 2 months, and more. (10) Vital organ functions (listed below) are preserved within 14 days prior to entry. 1. White blood cell count 3500/mm3>= (Neutrophils>=1500/mm3) 2. Platelets>=100,000/mm3 3. Total bilirubin>=upper limit of normal (ULN)*1.5 4. AST and ALT<=upper limit of normal (ULN)*2.5 (<=ULN*5 in case of liver metastasis) 5. Hemoglobin>=9.0g/dl 6. Serum creatinine<=upper limit of normal (ULN) 7. Urinary protein >= grade1 (+1) (11) Written informed consent.
Exclusion criteria
Exclusion criteria: (1) Hypersensitivity or History of the severe hypersensitivity for capecitabine, oxaliplatin or bevacizumab. (2) Prior abdominal irradiation for colorectal cancer. (3) CNS metastases or brain cancer confirmed by imaging (When it is suspected, imaging confirmation is required). (4) Complication of cerebrovascular disease or its symptoms within 1 year. (5) With sever complication (intestinal paralysis, intestinal obstruction, interstitial pneumonitis or pulmonary fibrosis, uncontrolled diabetes mellitus, hypertension, cardiac failure, renal failure, liver dysfunction, and so on). (6) With complication of history of gastrointestinal perforation, intestinal tract paralysis, or ileus within 1 year. (7) Massive pleural or ascites that required drainage. (8) Uncontrolled peptic ulcer. (9) Uncontrolled diarrhea. (10) Uncontrolled infection. (11) Diathesis of bleeding (history of hemoptysis, including cavitation and/or necrosis in lung metastasis confirmed by imaging), coagulopathy or abnormality of coagulation factor (12) Administrated antithrombotic drug or drug affected to congealing fibrinogenolysis system within 14 days before enrollment (Except for low-dose of aspirin.) (13) Active multiple primary cancer. (14) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers. (15) With mental disorder or psychological symptoms which disturb registration to this study. (16) Not appropriate for the study at the physician's assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month Progression free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate Disease control rate Progression free survival Overall survival Time to treatment failure Safety Exploring several predictable biomarkers | — |
Countries
Japan
Contacts
Public ContactMasashi Tsuruta
School of Medicine, Keio University Department of Surgery
Outcome results
None listed