Colorectal cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1)adenocarcinoma of colorectalcancer 2)KRAS wild type 3)histrogical type:adenocarcinoma(tub1, tub2, por), mucinous adenocarcinoma, signet cell carcinoma 4)Age;20 to 75 years old 5)ECOG PS;0 or 1 6)Survival time above 3 months are expected after registration to clinical trial 7)target lesion or non-target lesion by RECIST ver 1.1 8)3rd line chemotherapy and previous use of bevacizumab. 9)refractory or intolerance for fluoropyrimidine, L-OHP, irinotecan as previous chemotherapy 10)Adecuate organ function (laboratory data) 11)Patients could register this trial after 4weeks of surgery, 4weeks after radiation therapy, 2weeks of chemotherapy. 12)consent form of patients
Exclusion criteria
Exclusion criteria: 1) Double advenced cancer 2) Past history of severe allergy of drugs 3) Active infection 4) Severe complication such as paresis of intestine, ileus, intestinal pneumonia, uncontrollable DM, cardiac disease, uncontrolled hypertension, thrombosis, renal failure, liver failure 5) Previous use of anti-EGFR antibodies 6) Uncontorollable pleural effusion and acites 7) Asymptomatic brain metastasis 8) Active bleeding of intestine 9) Uncontrollable diarrhea 10) Female with pregnancy 11) Inappropriate patients for clinical trial that are judged by doctors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of dose limiting toxicity (DLT). | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical effect of chemotherapy, proportion of adverse events, PK and biomarkers | — |
Countries
Japan
Contacts
National Cancer Center Hospital, Tokyo, Japan. Gastrointestinal Onclogy Division