Phase II study of panitumumab rechallenge in the third-line therapy in patients with KRAS wild-type metastatic colorectal cancer

Phase II study of panitumumab rechallenge in the third-line therapy in patients with KRAS wild-type metastatic colorectal cancer - JACCRO CC-09 study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011440

Enrollment

Registered

2013-08-12

Start date

2013-08-12

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

metastatic colorectal cancer

Interventions

panitumumab + irinotecan panitumumab 6mg/Kg/bi-weekly irinotecan 150 mg/m2/bi-weekly

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Ptients with histologically proven colorectal cancer (2) KRAS wild-type (3) Patients showing clinical response (CR, PR or SD continuing 6 months or more) in first line panitumumab conbination therapy (4) First-line therapy with oxaliplatin and secomd-line therapy with irinotecan, or first-line therapy with irinotecan and second-line therapy with oxaliplatin (5) Patients with second-line therapy exept anti-EGFR antibody and regorafenib (6) Presence of evaluable lesion defined by RECIST criteria (7) ECOG performance status 0-2 (8) Age 20 years old or older (9) Life expectancy of 3 months or longer (10) Patients have enough organ function for study treatment assesed within 14 days before enrollment (11) Written informed consent

Exclusion criteria

Exclusion criteria: (1) Synchronous multiple maligmancy or metachronous multiple malignancy within 5 years disease free interval (2) Symptomatic brain metastases (3) Severe infectious disease (4) Comorbidity or history of interstitial lung disease or pulmonary fibrosis (5) Comorbidity or history of severe heart disease (6) Sensory alteration or paresthesia interfering with function (7) Large quantity of pleural, abdominal or cardiac effusion (8) Severe comobidity (renal failure, liver failure, hypertensio, etc) (9) Prio radiotherapy for primary and metastatic tumor (10) Men/women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test (11) Any other cases who are regarded as inadequate for study enrillment by investigators

Design outcomes

Primary

Measure	Time frame
3-Month Progression Free Survival Rate	—

Secondary

Measure	Time frame
response rate disease control rate overall survival progression free survival time to treatment failure safety	—

Countries

Japan

Contacts

Public ContactMasashi Fujii

Nonprofit Organization Japan Clinical Cancer Research Organization Office

cc09.dc@jaccro.or.jp03-5579-9882

Outcome results

None listed

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