Colorectal cancer
Conditions
Interventions
This is a multicentric phase II trial that examines patients who had a clinical benefit [confirmed stable disease (SD) for at least 6 months or clinical response] after a line of cetuximab- plus FOLFO
Sponsors
Okayama Molecular Target-Based Drugs Society for Cancer of the Colon and Rectum
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histopathological confirmation of Adenocarcinoma 2EGFR expression confirmed by immunohistochemistry either in the primary tumor or in metastatic tumor lesion 3)KRAS wild type (in codon 12, 13) confirmed, either in the primary tumor or in metastatic tumor lesion 4)Patients who had a clinical benefit [confirmed stable disease (SD) for at least 6 months or clinical response] after a line of cetuximab based chemotherapy and then a progression of disease or intolerable of adverse events, during cetuximab based chemotherapy, for which underwent a new line chemotherapy and finally, after a clear new progression of disease, were retreated with the same or another cetuximab chemotherapy. 5)Age of 20 or more years old 6)ECOG performance status of 0 to 2 7)Presence of at least one measurable lesion according to RECIST 8)Sufficient function of important organs 1. WBC:>= 2,000 /mm3 2. Neu: >= 1,500 /mm3 3. Platelet: >= 75,000 /mm3 4. Hemoglobin: >= 8.0 g/dL 5. Sr.bil : <= 2.5 mg/dL 6. AST, ALT: <= upper limits of normal (ULN)x2.5 (patients with liver metastasis; AST, ALT : <= ULNx5.0) 7. Serum creatinine: <= ULNx1.5 9)Expected more than 3 months survival 10)With written informed consent
Exclusion criteria
Exclusion criteria: 1)Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ 2)Patients with brain metastasis which have symptoms or patients with history of brain metastasis 3)Severe wattery diarrhea 4)Severe infectious disease 5)Severe complications (interstitial lung disease or pulmonary fibrosis, kidney failure, hepatic failure, uncontrolable diabetes, uncontrolable hypertension) 6)Severe carcinomatous ascites, pleural effusion or pericardial cavity effusion 7)Pregnant or lactating women or women of childbearing potential, and no birth-control 8)Patients with history of serious hypersensitivity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate(RR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival(PFS) Overall survival(OS) Safety | — |
Countries
Japan
Contacts
Public ContactTakeshi Nagasaka
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences Department of Gastroenterological Surgery
Outcome results
None listed