colorectal cancer
Conditions
Interventions
mFOLFOX6 + panitumumab
mFOLFOX6 + bevacizumab
Sponsors
National Cancer Center Hospital East
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Investigator and subinvestigator judge a candidate is understand clinical trial and comply this protocol. (2)Patients who have given written consent to take part in the study after detailed explanation of the study prior to enrollment (3)Aged 20 to <80 years at the time of informed consent (4)Patients with unresectable adenocarcinoma originating in the large intestine (excluding carcinoma of the appendix and anal canal cancer) (5)Patients with lesion(s) that can be evaluated. (6)Patients who have not received chemotherapy for colorectal cancer. Patients who experience relapse more than 24 weeks (168 days) after the final dose of perioperative adjuvant chemotherapy* with fluoropyrimidine agents may be enrolled. *: Patients who have received perioperative adjuvant chemotherapy including oxaliplatin are excluded. (7)Patients classified as KRAS/NRAS wild-type by KRAS/NRAS testing. KRAS: EXON2 (codon 12, 13), EXON3 (codon 59, 61), EXON4 (codon 117, 146) NRAS: EXON2 (codon 12, 13), EXON3 (codon 59, 61),EXON4 (codon 117, 146) (8)Patients who satisfy the following criteria for the major organ function in tests performed within 14 days prior to enrollment 1)Neutrophil count >= 1.5x103/micro;L 2)Platelet count >= 1.0x104/micro;L 3)Hemoglobin >= 9.0 g/dL 4)Total bilirubin <= 2.0 mg/dL 5)AST <= 100 IU/L (200 IU/L if liver metastases are present) 6)ALT <= 100 IU/L (200 IU/L if liver metastases are present) 7)Serum creatinine <= 1.5 mg/dL 8)PT-INR < 1.5 (< 3.0 for patients treated with oral warfarin) 9)Satisfies at least one of these conditions (i) Urine protein (dip stick method) <= 1+ (ii) UPC (urine protein creatinine) ratio <= 1.0 (iii) Urinary protein <= 1000mg/ 24hours (9)ECOG performance status (PS) of 0 or 1 (10)Life expectancy of >= 3 months (90 days) after enrollment
Exclusion criteria
Exclusion criteria: (1)Radiotherapy received within 4 weeks (28 days) prior to enrollment (2)Known brain metastasis or strongly suspected of brain metastasis (3)Synchronous cancers or metachronous cancers with a disease-free period of ; 5 years (excluding colorectal cancer) excluding mucosal cancers cured or be possibly cured by regional resection. (4)Body cavity fluid that requires treatment (pleural effusion, ascites, pericardial effusion, etc.) (5)Patients who do not want to use contraception to prevent pregnancy, and women who are pregnant or breast-feeding, or test positive for pregnancy (6)Nonhealing surgical wound (excluding implanted venous reservoirs) (7)Active hemorrhage requiring blood transfusion (8)Disease requiring systemic steroids for treatment (excluding topical steroids) (9)The patient who has placed colonic stent (10)Intestinal resection within 4 weeks prior to enrollment or colostomy within 2 weeks prior to enrollmentt (11)History or obvious and extensive CT findings of interstitial pulmonary disease (interstitial pneumonia, pulmonary fibrosis, etc.) (12)patients with unstable angina, myocardial infarction, cerebral hemorrhage, and have a arterial thromboembolism such as cerebral infarction, or history within 24 weeks (168 days) (except for asymptomatic lacunar infarction) (13)Serious drug hypersensitivity (14)Local or systemic active infection requiring treatment, or fever indicating infection (15)NYHA class II or higher heart failure or serious heart disease (16)Intestinal paralysis, gastrointestinal obstruction, or uncontrollable diarrhoea (incapacitating symptoms despite adequate treatment) (17)Poorly controlled hypertension (18)Poorly controlled diabetes mellitus (19)Active hepatitis B (20)Known HIV infection (21)Peripheral neuropathy of; Grade 2 by CTCAE (Japanese edition JCOG version 4.03) (22)Other patients judged by the investigator or subinvestigator to be ineligible for enrollment in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Overall survival (OS) 2. OS for Participants with Left-sided Tumors | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy Progression-free survival (PFS) Response rate (RR) Duration of response (DOR) Percentage of subjects treated with surgical resection after chemotherapy(complete resection) Safety Percentage of subjects with adverse events | — |
Countries
Japan
Contacts
Public ContactClinical Trial Information Contact for Clinical Trial Information
Takeda Pharmaceutical Company Limited Contact for Clinical Trial Information
Outcome results
None listed