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CETUXIMAB PLUS IRINOTECAN IN PREVIOUSLY TREATED METASTATIC COLORECTAL CANCER PATIENTS SELECTED ON THE BASIS OF KRAS MUTATION AND EGFR INTRON 1 CA TANDEM REPEATS: PHASE II PROSPECTIVE STUDY AND RETROSPECTIVE ANALYSES OF NEW POTENTIAL MOLECULAR PREDICTORS OF OUTCOME - RAS&RASH

CETUXIMAB PLUS IRINOTECAN IN PREVIOUSLY TREATED METASTATIC COLORECTAL CANCER PATIENTS SELECTED ON THE BASIS OF KRAS MUTATION AND EGFR INTRON 1 CA TANDEM REPEATS: PHASE II PROSPECTIVE STUDY AND RETROSPECTIVE ANALYSES OF NEW POTENTIAL MOLECULAR PREDICTORS OF OUTCOME - RAS&RASH

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-003160-19-IT
Enrollment
Unknown
Registered
2008-11-06
Start date
2008-09-07
Completion date
Unknown
Last updated
2014-02-17

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

Conditions

colorectal cancer MedDRA version: 9.1 Level: LLT Classification code 10001167 Term: Adenocarcinoma of colon

Interventions

Trade Name: ERBITUX Pharmaceutical Form: Solution for infusion INN or Proposed INN: Cetuximab Concentration unit: mg/m2 milligram(s)/square meter Concentration type: equal Concentration number: 2- Tr

Sponsors

G.O.N.O. - GRUPPO ONCOLOGICO NORD OVEST
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria:  Histologically confirmed colorectal adenocarcinoma (on primary and/or metastases).  Availability of paraffin-embedded samples of primary and/or metastases.  EGFR-positive tumor at immunohistochemistry.  Progression after a prior irinotecan-based regimen.  Measurable metastatic disease (RECIST criteria).  Age >18. Life expectancy >3 months. Subscription of informed consent to genetic analyses and to periodical blood sampling 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) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: &amp;#61607; Presence or history of CNS metastasis. &amp;#61607; Not measurable metastatic disease (RECIST criteria). &amp;#61607; Age <18. &amp;#61607; Life expectancy <3 months. &amp;#61607; Refusal of genetic analyses execution and to periodical blood sampling

Design outcomes

Primary

MeasureTime frame
Main Objective: to prospectively verify if the activity of cetuximab plus irinotecan combination treatment in metastatic colorectal cancer patients could be significantly improved selecting those bearing KRAS wild-type tumors and with EGFR intron 1 CA tandem repeats S/S or S/L germline genetic variants;Secondary Objective: : retrospective evaluation of the potential role of candidate molecular markers (i.e. intratumoral NF-kB activation, PTEN expression, BRAF mutation, EGFR gene copy number and plasma levels variation of TGF&amp;#945;, amphiregulin, EGF, betacellulin and neuregulin-1) in the prediction of benefit from cetuximab plus irinotecan combination treatment in the whole screened population;Primary end point(s): The primary study endpoint is response rate—

Countries

Italy

Outcome results

None listed

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