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

Phase II study of cetuximab rechallenge in the third-line therapy in patients with KRAS wild-type metastatic colorectal cancer - JACCRO CC-08 study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010638

Enrollment

Registered

2013-05-07

Start date

2013-05-07

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

cetuximab (first time) 400mg/m2/week, cetuximab (after 2nd time) 250mg/m2/week, irinotecan 150mg/m2/bi-weekly

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1) Synchronous multiple malignancy 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) Comobidity or history of severe heart failure. 6) Sensory alterration or paresthesia interfering with function. 7) Large quanity of pleural, abdominal or cardiac effusion. 8) Severe comobidity (renal failure, liver failure, hypertension, etc.) 9) Prior radiotherapy for primary and metastatic tumors. 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 enrollment 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

Japan Clinical Cancer Research Organization Office

cc08.dc@jaccro.or.jp03-5579-9882

Outcome results

None listed

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