Optimal strategy in K-ras wild type metastatic colorectal cancer patients: cetuximab plus FOLFIRI followed by FOLFOX+/- cetuximab (GOIM multicenter program) - 2906

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-014041-81-IT

Enrollment

320

Registered

2009-08-10

Start date

2009-11-13

Completion date

Unknown

Last updated

2016-04-18

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

Conditions

k-ras wild type metastatic colorectal cancer patients

Interventions

Trade Name: ERBITUX Pharmaceutical Form: Solution for infusion INN or Proposed INN: Cetuximab Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5- Trad

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -written informed consent - ages major than 18 years - diagnosis of histologically confirmed metastatic k-ras wild type adenocarcinoma of colon or rectum - presence of at least 1 bi-dimensionally measurable index lesion 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: - clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia - pregnansy or lactation period - acute or sub-acute intestinal occlusion - history of inflammatory bowel disease - known or suspected brain metastases

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of first line treatment is: - Evaluation of efficacy (in terms of PFS) of ongoing FOLFIRI + Cetuximab as first line treatment in wild type (WT) K-ras metastatic colorectal cancer patients. the primary objective of second line treatment is: - evaluation of efficacy (in terms of PFS) of ongoing cetuximab as second line tretment in combination with chemotherapy after progerssion of first line treatment with FOLFIRI plus cetuximab in wild type (WT) K-ras metastatic colorectal cancer patients.;Secondary Objective: The secondary objectives of first line treatment line are: - the efficacy of cetuximab in combination with FOLFIRI by assessment of overall response rate (ORR; complete response (CR) + partial response (PR)) and duration of response - To evaluate if there is a correlation between clinical outcome (RR, PFS, OS) and tumor biomarkers abtained at baseline and during treatment. Tumor biomarkers will be collected from archived tumor/metastasis biopsies and from blood samples. - Analysing tumor sample to assess any acquired resistance mechanisms to cetuximab The secondary objectives of second line treatment are: -The efficacy of FOLFOX +/- cetuximab by assessment of overall survival (OS), overall response rate (ORR; complete response + partial response), time to progression (TTP).;Primary end point(s): The primary objective of first line treatment is: - Evaluation of efficacy (in terms of PFS) of ongoing FOLFIRI + Cetuximab as first line treatment in wild type (WT) K-ras metastatic colorectal cancer patients. the primary objective of second line treatment is: - evaluation of efficacy (in terms of PFS) of ongoing cetuximab as second line tretment in combination with chemotherapy after progerssion of first line treatment with FOLFIRI plus cetuximab in wild type (WT) K-ras metastatic colorectal cancer patients	—

Measure

Time frame

Main Objective: The primary objective of first line treatment is: - Evaluation of efficacy (in terms of PFS) of ongoing FOLFIRI + Cetuximab as first line treatment in wild type (WT) K-ras metastatic colorectal cancer patients. the primary objective of second line treatment is: - evaluation of efficacy (in terms of PFS) of ongoing cetuximab as second line tretment in combination with chemotherapy after progerssion of first line treatment with FOLFIRI plus cetuximab in wild type (WT) K-ras metastatic colorectal cancer patients.;Secondary Objective: The secondary objectives of first line treatment line are: - the efficacy of cetuximab in combination with FOLFIRI by assessment of overall response rate (ORR; complete response (CR) + partial response (PR)) and duration of response - To evaluate if there is a correlation between clinical outcome (RR, PFS, OS) and tumor biomarkers abtained at baseline and during treatment. Tumor biomarkers will be collected from archived tumor/metastasis biopsies and from blood samples. - Analysing tumor sample to assess any acquired resistance mechanisms to cetuximab The secondary objectives of second line treatment are: -The efficacy of FOLFOX +/- cetuximab by assessment of overall survival (OS), overall response rate (ORR; complete response + partial response), time to progression (TTP).;Primary end point(s): The primary objective of first line treatment is: - Evaluation of efficacy (in terms of PFS) of ongoing FOLFIRI + Cetuximab as first line treatment in wild type (WT) K-ras metastatic colorectal cancer patients. the primary objective of second line treatment is: - evaluation of efficacy (in terms of PFS) of ongoing cetuximab as second line tretment in combination with chemotherapy after progerssion of first line treatment with FOLFIRI plus cetuximab in wild type (WT) K-ras metastatic colorectal cancer patients

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 23, 2026