Unresectable advanced/recurrent colorectal cancer
Conditions
Interventions
mtTFA(+):Oxaliplatin 130mg/m2 i.v. (day1) Bevaciumab 7.5mg/Kg i.v. (day1) Capecitabine2,000mg/m2 p.o.(day1-14) to be repeated every 3 weeks until progression
mtTFA(+):Irinotecan 200mg/m2 i.v. (da
Sponsors
Fukuoka University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Written informed consent. 2)Histologically confirmed adenocarcinoma of the colon or rectum. 3)unresectable or recurrent colorectal cancer. 4)No prior chemotherapy for the patients with unresectable or recurrent colorectal cancer. (1)Not include Neoadjuvant chemotherapy. (2)Previous adjuvant therapy is permitted if completed at least 6 months before registration. 5)No prior radiotherapy for target lesion. 6)Age >= 20 and =< 80. 7)Performance status(PS) of 0-2 in ECOG criteria. 8)With measurable lesion. 9)At least one measurable lesion based on the RECIST criterion. (within 28 days before registration) 10)Life expectancy more than 3 months. 11)Required baseline laboratory parameters (within 1 week before registration): (1)WBC more than 2000 and WBC less than 12000/mm3. (2)Neu more than 1,500/ mm3. (3)Plt more than 75,000/ mm3. (4)Hb more than 9.0g/dl. (5)T-Bil less than 2.0mg/dl. (6)AST,ALT 100IU/L and under.(<200 U/L in patients with liver metastasis) (7)PT(INR) less than 1.5. (8)Cre male:less than 1.35mg/dl, Female:less than 1.8mg/dl. 12)Urine protein controllable.
Exclusion criteria
Exclusion criteria: 1)Administering transfusion/ hematopoietic factor or G-CSF and antithrombotic drug within 7 days. 2)Serious liver and renal dysfunction. 3)Serious drug hypersensitivity or a history of drug allergy. 4)Peripheral neuropathy. 5)Active double cancer. 6)Severe infectious disease. 7)High blood pressure and diabetic that cannot be controlled. 8)Symptomatic or asymptomatic but treated heart disease. 9)History of interstitial pneumonitis, pulmonary fibrosis or high-grade pulmonary emphysema. 10)History of mental disturbances or cerebrovascular accident. 11)Fresh hemorrhage from digestive tube, intestines tube paralysis, intestinal obstruction and peptic ulcer. 12)Current or previous (within one year) history of GI perforation. 13)Pleural effusion, peritoneal fluid and pericardial fluid. 14)Symptomatic brain metastasis. 15)Water solubility diarrhea. 16)Under coutinuous steroid therapy. 17)Any surgical treatments including skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week. 18)Anti-platelets therapy.(including aspirin and NSAIDS) 19)History of organ transplantation. 20)Traumatic fracture of unrecovery. 21)Bevacizumab used previous chemotherapy. 22)Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers. 23)Other conditions not suitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate with or without mtTFA expression | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival with or without mtTFA expression Overall survival with or without mtTFA expression Safety | — |
Countries
Japan
Contacts
Public ContactYoichiro Yoshida
Fukuoka University School of Medicine Department of Gastroenterologial Surgery
Outcome results
None listed