A multi-center, open label, non-randomized, phase II study to assess the activity and safety of cetuximab plus irinotecan in subjects with EGFR-detectable metastatic colorectal carcinoma

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080220192

Enrollment

Registered

2005-12-21

Start date

2005-12-21

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 carcinoma

Interventions

investigational material(s) Generic name etc : cetuximab (EMR-62202/BMS-564717) INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnosis of histologically confirmed, metastatic colorectal carcinoma (CRC) that is surgically unresectable. 2. Immuno histochemical evidence of EGFR expression. 3. Patients who have documented progressive disease to irinotecan based chemotherapy. 4. Patients who have failed previous fluoropyrimidine based chemotherapies. 5. Patients who have failed previous oxaliplatin-based chemotherapies. 6. Presence of at least one unidimensionally measurable lesion (target lesion by RECIST criteria). 7. Performance Status : 0 - 2

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Efficacy: response rate, duration of observed response Safety: incidence rates and severity of observed adverse events	—

Outcome results

None listed

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