Colorectal Cancer
Conditions
Interventions
Chemotherapy (Panitumumab + irinotecan or panitumumab)
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: 20 to 75 years 5) ECOG performance status of 0, 1 or 2 6) Expected survival time of more than 2 months after registration 7) At least one measurable lesion based on the RECIST criterion 8) Irinotecan and fluoropyrimidine and oxaliplatin resistant or intolerable case 9) No prior anti-EGFR therapies 10) Required baseline laboratory parameters (within 7 days before registration): Hb more than 8.0 g/dl WBC more than 3000 and WBC less than 12000/ul Plt more than 75,000/ul T-Bil less than 1.5 mg/dl GOT less than 100 IU/l GPT less than 100 IU/l Cre less than 1.5 mg/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 registration
Exclusion criteria
Exclusion criteria: 1) other active malignancies within 5 years 2) history of 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, etc.) 5) patients who have abnormal findings on ECG and need any treatment (within 4 weeks before registration) 6) moderate/severe pleural effusion or ascites 7) symptomatic brain metastasis 8) patients who need transfusion because of GI bleeding 9) uncontrolled watery diarrhea (watery colostomy output without trouble during patient's daily living is allowed) 10) pregnant or lactating women, women who are capable of pregnancy or intend to get pregnant, men who do not intend to have protected intercourse 11) any other cases who are regarded as unsuitable for enrollment in the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate of Panitumumab + irinotecan regimen | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, Overall survival, Time to progression, Time to progression of irinotecan combined regimen, Feasibility of Short-term Infusion of Panitumumab, Incidence of grade 2/3/4 skin toxicity during the skin treatment period | — |
Countries
Japan
Contacts
Public ContactKohei Akiyoshi
National Cancer Center Hospital Gastrointestinal Oncology Division
Outcome results
None listed