Colorectal Cancer
Conditions
Interventions
FOLFIRI+Ramucirumab (5-FU(bolus): 400mg/m2 on day1, 5-FU(ci): 2,400mg/m2 on day1-3 (46hr), l-LV: 200mg/m2 on day1, CPT-11: 180*mg/m2 on day1, Ramucirumab: 8mg/kg on day1) *Allow dose level -1 (150
Sponsors
MCSGO: Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically confirmed colorectal cancer (is not included appendiceal cancer) 2) Confirmed recurrent colorectal cancer 3) Has a history of receiving oxaliplatin and fluoropyrimidine as adjuvant chemotherapy and corresponded to the one of the following criterion, a) experienced radiographic recurrence during chemotherapy b) experienced radiographic recurrence within 12 months after discontinuation of chemotherapy due to the adverse events c) experienced radiographic recurrence within 12 months after the completion of scheduled chemotherapy d) doctor judged the patients were intolerant to oxaliplatin 4) Has measureable or nonmeasurable disease based on RECIST v 1.1 5) The patient who is expected to survive more than 3 months after the initiation of administration. 6) Has resolution to Grade=<1, per the NCI-CTCAE v. 4.03, of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy, with the exception of peripheral neuropathy, which must have resolved to Grade =<2 and except where otherwise noted in the eligibility criteria. 7) Has an ECOG performance status of 0 or 1. 8) Has adequate hematologic function 9) Has adequate coagulation function 10) They are clinically stable, asymptomatic, and adequately treated with anticoagulation in the opinion of the investigator 11) Has adequate hepatic function 12) Has adequate renal function 13) Urinary protein is less than 1+ on dipstick or routine urinalysis 14) The patient has had disease notification and is able to provide signed informed consent. 15) >=20 years of age. 16) Eligible patients of reproductive potential (both sexes) must agree to useadequate contraception methods (hormonal or barrier methods) during thestudy period and at least 12 weeks after the last dose of study treatment or longer if required per local regulations.
Exclusion criteria
Exclusion criteria: 1) Has simultaneous or metachronous 2) Has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders 3) Has an uncontrolled intercurrent illness 4) Has experienced any arterial thrombotic or arterial thromboembolic events 5) Receiving chronic antiplatelet therapy, including aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), dipyridamole or clopidogrel, or similar agents. Once-daily aspirin use (maximum dose 325 mg/day) is permitted 6) Has known (currently or in the past) leptomeningeal disease or brain metastases or uncontrolled spinal cord compression 7) Has an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy 8) Either of HIV-1 antibody, HIV-2 antibody or HBs antigen is positive 9) The patient who is HBs antibody or HBc antibody positive and HBV-DNA positive 10) Has received a prior autologous or allogeneic organ or transplantation 11) Has undergone major surgery within 28 days prior to randomization or subcutaneous venous access device placement within 7 days prior to randomization 12) Has had a serious nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization 13) Has an elective or planned major surgery to be performed during the course of the trial 14) Has an acute or subacute bowel obstruction or history of chronic diarrhea which is considered clinically significant in the opinion of the investigator 15) Has experienced a Grade 3 or higher bleeding event within 3 months prior to randomization 16) Has either peptic ulcer disease associated with a bleeding event, or known active diverticulitis 17) Has a known history or clinical evidence of Gilberts Syndrome, or is known to have any of the following genotypes: UGT1A1*6/*6, UGT1A1*6/*28, UGT1A1*28/*28 18) The patient desires to have children. 19) The patient whose participation is in the trial is inappropriate by the doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS), Time to treatment failure (TTF), Response Rate (RR), Disease Control Rate (DCR), Adverse Events | — |
Countries
Japan
Contacts
Public ContactNaotoshi Sugimoto
Osaka International Cancer Institute Medical Oncology
Outcome results
None listed