Multicenter phase II trial of panitumumab plus irinotecan and S-1 (PIRIS regimen) in patients treated by oxaliplatin-based chemotherapy with K-RAS wild-type advanced colorectal cancer.

Multicenter phase II trial of panitumumab plus irinotecan and S-1 (PIRIS regimen) in patients treated by oxaliplatin-based chemotherapy with K-RAS wild-type advanced colorectal cancer. - Phase II trial of panitumumab plus irinotecan and S-1 (PIRIS regimen) in patients treated by L-OHP-based chemotherapy with advanced colorectal cancer.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004574

Enrollment

Registered

2010-12-01

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

Colorectal Cancer

Interventions

Take care of skin before the PIRIS regimen (moistureizer,sunscreen,steroid, antibiotic). Day1/Day15 panitumumab 6mg/kg irinotecan 125mg/m2 Day1~14 S-1 80-120mg/m2 q4w(until progressive d

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Histopathologically confirmed colorectal cancer. 2)Evaluable tumor lesions. 3)Colorectal cancer that is not amenable to curative resection and have previously received chemotherapy containing oxaliplatin-based chemotherapy or relapsed within six months (or during its treatment) after adjuvant of FOLFOX. 4)K-RAS wild-type. 5)Oral administration of S-1 is possible. 6)ECOG Performance status(PS) of 0-2. 7)Age of 20 years or older. 8)A life expectancy of more than 12 weeks. 9)No severe organ failure: and suitable results of all laboratory test performed within 7 days before enrollment. White blood cell count >= 3,000/mm3 and <= 12,000/mm3 or neutrophil count >= 1,500/mm3 platelet count >= 75,000/mm3 AST(GOT) and ALT(GPT) <= 3 times the institutional upper limit of normal or <= 5 times if the patient has liver metastasis Total bilirubin <= 2.0mg/dL serum creatinine <= 1.2 times the institutional upper limit of normal 10)Written informed consent will be obtained from each patient before enrollment. 11)Periods from prior treatment have elapsed more than two weeks.

Exclusion criteria

Exclusion criteria: 1)A history of CPT-11 or cetuximab (C225) use. 2)A history of serious drug hypersensitivity or serious drug allergy. 3)Clinically important infection or suspected infection in febrile patients. 4)Diarrhea(watery) or diarrhea that interferes with daily activities for patients with a stoma. 5)Active double cancer. 6)Paralytic or occlusive ileus. 7)Uncontrolled body cavity fluid. 8)Symptomatic brain metastasis. 9)Clinically significant heart disease. 10)Severe pulmonary disease. 11)Gastrointestinal ulceration or bleeding. 12)Central nervous system disorders. 13)Uncontrolled diabetes. 14)Women who are pregnant, lactating, or wish to become pregnant or men who expect babies. 15)Judged to be unsuitable for this trial due to clinically significant mental / psychological disease etc. 16)Under treatment with atazanavir, flucytosine, phenytoin, warfarin potassium 17)Judged to be ineligible by principal investigator for any other reason.

Design outcomes

Primary

Measure	Time frame
Response ratte : RR	—

Secondary

Measure	Time frame
1)Progression free survival :PFS 2)Time to treatment failure :TTF 3)Overall survival :OS 4)Skin toxitiy 5)Adverse Event :AE	—

Countries

Japan

Contacts

Public ContactSotarou akatsuka

Yokohama Rosai Hospital Division of Medical Oncology

045-474-8111

Outcome results

None listed

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