An exploratory pharmacogenomic study of cetuximab monotherapy in patients with metastatic EGFR-Positive colorectal carcinoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002837-37-ES

Enrollment

180

Registered

2005-05-16

Start date

2004-11-11

Completion date

Unknown

Last updated

2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic colorectal carcinoma MedDRA version: 7.0 Level: LLT Classification code 10052362

Interventions

Trade Name: Erbitux Product Name: Erbitux Product Code: EMD271786 Pharmaceutical Form: Solution for infusion INN or Proposed INN: cetuximab Current Sponsor code: EMD271786 Other descriptive name: C225

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with metastatic, EGFR-positive colorectal cancer who have received at least one prior chemotherapeutic regimen for advanced disease, or have refused prior treatment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Previous treatment with cetuximab or other therapy which targets the EGFR pathway - Prior chimerized or murine monoclonal antibody therapy - Any concurrent chronic systemic immune therapy, chemotherapy not indicated in the study protocol, radiation therapy, hormonal therapy (except for physiological replacement), or any other investigational agent.

Design outcomes

Primary

Measure	Time frame
Main Objective: To explore whether Muc 2, Muc 3, CFTR, SERPINB-5, BMP-2, BTC, TLN2, EPHA1, HMGCoA or Spondin expression can predict response to CETUXIMAB treatment.;Secondary Objective: - To determine the feasibility of escalating the weekly dose of Cetuximab beyond 250 mg/m2 - To evaluate the relationship between grade =2 skin rash and tumour response rate - To describe any evidence of anti-tumour activity observed with cetuximab - To further characterised the safety and tolerability of standard and escalated weekly doses of cetuximab;Primary end point(s): The primary end point will be the tumoral response according a modified form of the WHO (WHO handbook of reporting results of cancer treatment, Geneva, 1979). All patients who received at least one dose of cetuximab will be considered evaluable for response, unless it is determined that the subject's diagnosis of metastatic colorectal cancer was made in error or the subject does not have measurable disease.	—

Measure

Time frame

Main Objective: To explore whether Muc 2, Muc 3, CFTR, SERPINB-5, BMP-2, BTC, TLN2, EPHA1, HMGCoA or Spondin expression can predict response to CETUXIMAB treatment.;Secondary Objective: - To determine the feasibility of escalating the weekly dose of Cetuximab beyond 250 mg/m2 - To evaluate the relationship between grade =2 skin rash and tumour response rate - To describe any evidence of anti-tumour activity observed with cetuximab - To further characterised the safety and tolerability of standard and escalated weekly doses of cetuximab;Primary end point(s): The primary end point will be the tumoral response according a modified form of the WHO (WHO handbook of reporting results of cancer treatment, Geneva, 1979). All patients who received at least one dose of cetuximab will be considered evaluable for response, unless it is determined that the subject's diagnosis of metastatic colorectal cancer was made in error or the subject does not have measurable disease.

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Countries

Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026