phase 2 trial of panitumumab and irinotecan in previously oxaliplatin and irinotecan refractory patients with colorectal cancer

phase 2 trial of panitumumab and irinotecan in previously oxaliplatin and irinotecan refractory patients with colorectal cancer - phase 2 trial of panitumumab and irinotecan

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004500

Enrollment

Registered

2010-11-02

Start date

2010-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Interventions

Patients receive panitumumab and irinotecan until progression.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) unresectable or recurrent colorectal cancer histlogical proven 2)KRAS wild type in codon 12 and 13 in the primary or metastatic tumor tissue is confirmed 3) disease progression at the irinotecan containing chemotherapy or until 3 months from the last chemotherapy 4) fluorouracil refractory 5) oxaliplatin refractory 6) presence of at least one measurable lesion according to the RECIST 7) ECOG PS 0-2 8) No treatment duration after following treatment a) radiotherapy 2weeks b) organ resection 2weeks c) chemotherapy 2weeks d) hormone therapy 2weeks e) cytokine therapy, BRM 2weeks 9) patients have enough organ function for study treatment 1. neutrophil>=1,000/mm3 2. Platelet>=100,000/mm3 3. AST and ALT<=upper limit of normal (ULN)*3 (<=ULN*5 in case of liver metastasis) 4. Total bilirubin<=upper limit of normal (ULN)*3 5. Creatinin <=2.0mg/dL 10) Life expectancy of 8 weeks 11) written informed consent

Exclusion criteria

Exclusion criteria: 1) symptomatic brain metastasis 2) waterly diarrhea 3) Paralytic or mechanical bowel obstruction 4) severe infectious disease 5) severe plumonary disease (interstitial lung disease or plumonary fibrosis) 6) severe complications (uncontrolable diabetes, heart failure NYHA>=III, renal failure, liver failure) 7) Pregnant or lactating women or women of childbearing potential 8) carcinomatosis meningitis 9) peripheral neuropathy Grade>=3 10)Need to treatment with flucytosine, atazanavir sulfate 11) history of Grade>=3 hypersensitivity due to monoclonal antibody therapy 12) history of Grade>=3 hypersensitivity due to irinotecan 13) history of treatment of anti EGFR pathway 14) patients judged inappropriate for this study by physicians

Design outcomes

Primary

Measure	Time frame
response rate	—

Secondary

Measure	Time frame
disease control rate, duration of response, progression free survival, overall survival, incidence of adverse events.	—

Countries

Japan

Contacts

Public ContactTomohiro Nishi

Tochigi Cancer Center Department of medical oncology

028-658-5151

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026