A phase II study of Panitumumab combined with Irinotecan and S-1 as second line therapy in metastatic colorectal cancer patients with KRAS wild type

A phase II study of Panitumumab combined with Irinotecan and S-1 as second line therapy in metastatic colorectal cancer patients with KRAS wild type - A phase II study of Panitumumab combined with Irinotecan and S-1 as second line therapy in metastatic colorectal cancer patients with KRAS wild type

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004697

Enrollment

Registered

2010-12-10

Start date

2010-12-01

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

advanced colorectal cancer

Interventions

Panitumumab

bi-weekly administration 6mg/kg. Irinitecan is administered as an intravenous infusion at a dose of 120mg/m2 on day 1 and 15. And TS-1 is orally administered on days 1-14 of a 28-day cycle. Administr

1.25m2, 40mg twice daily

1.25-1.5m2, 50mg twice daily

&gt

1.5m2, 60mg twice daily.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed advanced or metastatic colorectal cancer. 2) Unresectable advanced or metastatic colorectal cancer 3) EGFR expressed and KRAS wild type in codon 12 and 13 4) Presence of measurable lesion(RECIST1.1 ) 5) A patients received chemotherapy containing XELOX with or without bavacizumab. 6) Age between 20 to 75 years. 7) ECOG performance status 0. 8) Life expectancy of more than 16 weeks. 9) Adequate hematological (absolute white blood cell count >3000/mm3, neutrophil count >1500/mm3, platelets >100000/mm3, Hb >10 g/dl), hepatic (AST and ALT within 2 times the upper limit of normal for the institution, serum bilirubin level below 1.5 mg/dl) and renal (serum creatinine level below 1.5 mg/dl and BUN under 25 mg/dl) function, with at least one measurable site of disease (>1 cm in at least one dimension). No patients accepted into this had received any prior chemotherapy, except for adjuvant chemotherapy completed more than 6 months before study entry. 10) Written informed consent 11) Protocol was approved by the institutional ethics committee.

Exclusion criteria

Exclusion criteria: Patients are excluded from this trial for any of the following exclusion criteria: symptomatic infectious disease, bleeding tendency, severe heart disease, pre-existing symptomatic peripheral neuropathy, active double cancer, symptomatic ascites, pregnancy, breast feeding, obstructive bowel disease, severe diabetes mellitus requiring insulin or past history of drug allergy.

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Toxicity, overall survival, progression-free survival, disease control rate	—

Countries

Japan

Contacts

Public Contactmanabu shiozawa

Kanagawa Cancer Center Gastrointestinal Surgery

shiozawam@kcch.jp0455202222

Outcome results

None listed

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