Investigation of usability of combination therapy with S-1 plus panitumumab in patients with KRAS wild type unresectable advanced and recurrent colorectal cancer, who had previously received on fluoropyrimidine, oxaliplatin and irinotecan ; phase II study.

Investigation of usability of combination therapy with S-1 plus panitumumab in patients with KRAS wild type unresectable advanced and recurrent colorectal cancer, who had previously received on fluoropyrimidine, oxaliplatin and irinotecan ; phase II study. - Investigation of usability of combination therapy with S-1 plus panitumumab in patients with KRAS wild type unresectable advanced and recurrent colorectal cancer, who had previously received on fluoropyrimidine, oxaliplatin and irinotecan ; phase II

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007274

Enrollment

Registered

2012-02-17

Start date

2012-04-01

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

Panitumumab/S-1 combination therapy Panitumumab 6mg/kg, biweekly S-1 80mg/m2/day, po from day 1 to 28 of each 42 days cycle

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Written informed consent 2) Patients who is judged by investigator to be able to receive the protocol therapy 3) Patients with histologically proven colorectal cancer and clinically proven unresectable advanced/recurrent colorectal cancer 4) Presence of measurable lesion judged by enhanced CT according to the RECIST 1.1(within 28 days before registration) 5) Patients who had previously received on fluoropyrimidine, oxaliplatin and irinotecan 6) Patients who had documented PD of 5FU based chemotherapy 7) KRAS wild type 8) Prior chemotherapy was done in the first study treatment before at least 2 weeks 9) Aged 20<= and 80>= years 10) ECOG performance status 0-1(including outpatients) 11) Orally administerable 12) Life expectancy of 3 months 13) Patients have enough organ function based on blood test within 2 week before registration 1. WBC >=3,000/mm3, <=12,000/mm3 2. Neutrophils >=1,500/mm3 3. Platelets >=100,000/mm3 4. Hemoglobin >=9.0g/dl 5. Total bilirubin <=2.0mg/dl 6,7. AST and ALT <= 100IU/l (200IU/l in the case of liver metastasis) 8. Creatinine <=1.5mg/dl 9. Creatinine clearance >=50ml/min

Exclusion criteria

Exclusion criteria: 1) Severe bone marrow suppression 2) Severe infectious disease 3) Massive pleural effusion or ascites 4) Comorbidity or history of severe heart failure (chronic heart failure, myocardial infarction, severe arrhythmia) 5) Comorbidity or history of interstitial pneumonia, comorbidity of pulmonary fibrosis 6) Paralytic or mechanical bowel obstruction 7) liver cirrhosis, jaundice 8) History of severe hypersensitivity 9) Positive for hepatitis B or C virus 10) Impossible to evaluate disease by enhanced CT 11) Pregnant or lactating women or women of childbearing potential 12) Severe comorbidity (uncontrolable diabetes, hypertension, hypercarcemia etc) 13) Symptomatic brain metastasis 14) Simultaneous or metachronous double cancers 15) Patients who had received anti EGFR drug that include panitumumab 16) Any other cases that are regarded as inadequate for study enrollment by the investigator.

Design outcomes

Primary

Measure	Time frame
Progression free survival (PFS)	—

Secondary

Measure	Time frame
Overall response rate Overall survival Overall survival from first diagnosis Disease control rate (CR+PR+SD) Time to treatment failure Dose-intensity Safety (rate and severity of adverse event, especially, dermatopathy)	—

Countries

Japan

Contacts

Public ContactKSCC secretariat

Clinical Research Support Center Kyushu KSCC secretariat

kscc2@cres-kyushu.or.jp092-631-2920

Outcome results

None listed

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