advanced and recurrent colorectal cancer
Conditions
Interventions
FOLFIRI:irinotecan 150mg/m2, l-LV 200mg/m2 5FU400mg/m2(bolus), 2400mg/m2(infusional) Panitumumab:6mg/kg to be repeated every 2 weeks until meeting the withdrawal criteria.
Sponsors
Kyoto Prefectural University of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with pathologically proven colorectal cancer (adenocarcinoma) and unresectable 2)Patients with tumor resistant/intolerant (failure) to oxaliplatin therapy failure (resistant/intolerant): PD on the therapy of recurrence within 6 months after the adjuvant therapy. Stop of treatment due to allergic reaction, withdrawal neuro-toxicity and/or ohter toxic events 3)genetically proven KRAS wild type on the tumor tissue 4)Performance Status 0-1 (ECOG) 5)with rest period of treatment 4 weeks for radiation therapy, 2 weeks for chemotherapy 6)with a good condition of important organs 1.BM: WBC>3500/mm3, platelet>100,000/mm3 2.hepatic function: total bilirubin >2.0mg/dL, AST/ALT<100IU/L 3.renal function: creatinine <= normal limit of each
Exclusion criteria
Exclusion criteria: 1)A history of CPT-11 use 2)Contraindications to panitumumab 3)Contraindications to irinotecan 1.Severe bone marrow suppression 2.infection 3.Diarrhea 4.intestinal paralysis and intestinal obstruction 5.interstitial pneumonia, pulmonary fibrosis 6.Massive pleural or abdominal effusion 7. Icterus 8.Need to treatment with atazanavir sulfate 9.History of serious drug hypersensitivity " 4)Any other cases who are regarded as inadequate for study enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival Overall Survival Safety Efficacy according to B-RAF status (ORR,PFS,OS,Safety) | — |
Countries
Japan
Contacts
Public ContactMasayoshi Nakanishi
Kyoto Prefectural University of Medicine Digestive Surgery
Outcome results
None listed