Colorectal Cancer
Conditions
Interventions
Sponsors
National Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Unresectable advanced or recurrent colorectal cancer. 2) KRAS wild type 3) Histologically proved adenocarcinoma, mucinous carcinoma, or signet ring cell carcinoma of the colon or rectum. In the recurrent case, histology of the primary site must have been confirmed in the past. Additional histological confirmation of metastatic or recurrent site is not necessary. 4) Age more than 20years and less than 75 years. 5) ECOG performance status of 0,1 or 2. 6) Survival time more than 2 months after registration expect 7) At least one measurable lesion based on the RECIST criterion. 8) Irinotecan and fluoropyrimidine and oxaliplatin resistant or intorerable case 9) No prior anti-EGFR therapyies 10) Required baseline laboratory parameters (within 7 days before registration): Hb more than 8.0g/dl WBC more than 3000 and WBC less than 12000/ul Plt more than 75,000/ul T-Bil less than 1.5mg/dl GOT less than 100 IU/l GPT less than 100 IU/l Cre less than 1.5mg/dl 11) Required no therapy time from prior therapy to registration Surgical procedure over 4 weeks before registration Radiation :4 weeks Chemotherapy:4 weeks 12) Signed informed consent of the patient for the registration.
Exclusion criteria
Exclusion criteria: 1) active other malignancies within 5 years 2) history of the severe drug hypersensitivity 3) clinically significant infectious disease(body temperature less than 38.0 degrees) 4) severe complications (ileus, bowel obstruction, interstitial lung disease, pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, hepatic failure and so on) 5) Patients who have abnormal findings on ECG and need any treatment (within 4 weeks before the registration.) 6) Moderate/severe pleural effusion or ascites 7) Symptomatic brain metastasis 8)Patient need transfusion because GI bleeding 9) Uncontrolled watery diarrhea. Watery colostomy output without trouble with patient's daily living is allowed. 16) Pregnant or lactating women, women who are capable of pregnancy or intend to get pregnant, men who don't intend to have protected intercourse. 17) Any other cases who are regarded as inadequate for study enrollment by the investigator.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Response Rate, Progression free survival, Overall survival,Time to progression, The incidence of grade 3/4 Skin toxicity,Time to progression of irinotecan combined regimen(A group) | — |
Primary
| Measure | Time frame |
|---|---|
| Adverse events of grade 3/4 | — |
Countries
Japan
Contacts
Public ContactKen Kato
National Cancer Center Hospital Gastrointestinal Oncology Division
Outcome results
None listed