Metastatic Colorectal Cancer
Conditions
Interventions
A group Panitumumab is administered intravenously in 6mg/kg by biweekly skin care+antibiotics Clarithromycin is administered orally twice a day
B group Panitumumab is administered intraveno
Sponsors
Multicenter Study Group of Osaka (MCSGO), Colorectal Cancer Treatment Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histopathological cinfirmation of colorectal cancer (excluding vermiform appendix and proctodeum) 2) KRAS wild type 3) Patients with metastatic colorectal cancer, which is measurable based on RECIST, planned to be treated with a panitumumab containing regimen (each line, each chemotherapy regimen) 4) No previous history of chemotherapy with anti EGFR antibody 5) Age=>20 and<=80 6) ECOG Performance status:0-2 7) Treatment free interval with more than 2 weeks after last chemotherapy and radiotherapy and surgical treatments including evisceration 8) Sufficient organ functions within 14 days prior to entry i) neutrophils>=1500/ul ii) platelets>=100,000/ul iii) Hemoglobin>=9.0g/dl iv) serum creatinine<=1.5xULN v) serum Mg>=lower limit of normal vi) serum Ca>=ower limit of normal vii) AL-P<=3xULN (5 x upper limit of normal in case of liver metastasis) viii)AST<=3xULN (5 x upper limit of normal in case of liver metastasis) ix)ALT<=3xULN (5 x upper limit of normal in case of liver metastasis) x)Total bilirbin<=1.5xULN 9)No severe complication(especially intestinal obstruction, diarrhea, fever) 10) Expected survival>=3months 11) Written informed consent obtained from the patient
Exclusion criteria
Exclusion criteria: 1)Previous history of chemotherapy with anti EGFR antibody 2)Contraindications to panitumumab 3)Complications or history of interstitial pneumonia, pulmonary fibrosis 4)Pregnant woman, possibly pregnant woman 5) Contraindications to clarithromycin 6)Any other cases who are not suitable for combination chemotherapy 7) Any other cases who are regarded as inadequate for study enrollment by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence rates of skin toxicity (>=Grade2) with or without antibiotics during the 6 weeks from the treatment started | — |
Secondary
| Measure | Time frame |
|---|---|
| time to the first appearance of skin toxicity (Grade>=2), incidence rates of skin toxicity(Grade>=3), response rate, disease control rate and progression free survival(each line, each chemotherapy regimen), difference between patients' and doctors' view to the side effects | — |
Countries
Japan
Contacts
Public ContactTaishi Hata
Osaka University Graduate School of Medicine Gastroenterological Surgery
Outcome results
None listed