Therapy for metastatic colorectal cancer

Biomarker directed treatment in metastatic colorectal cancer - AGMT_ERCC1

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003217-41-AT

Enrollment

Registered

2011-12-06

Start date

2012-05-23

Completion date

Unknown

Last updated

2020-09-07

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

Conditions

This pilot study is being mounted to assess whether treatment assignment by ERCC-1 gene expression status suggests better clinical results from historical experience in mCRC. MedDRA version: 20.0 Level: PT Classification code 10052358 Term: Colorectal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 100000016864

Interventions

Trade Name: According to local standard of care but approved in Austria Product Name: Cetuximab Pharmaceutical Form: Solution for infusion INN or Proposed INN: CETUXIMAB CAS Number: 205923-56-4 Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Untreated wild-type RAS metastatic colorectal cancer patients Previous adjuvant therapy must have been completed = 1 year before therapy initiation. Measurable disease with CT or MRI ECOG performance status of 0-2 Adequate tissue to evaluate for genotyping Adequate organ function Hematologic: Absolute neutrophil count > 1,500/µL Hemoglobin >9 mg/dl Platelet count >100,000 /µl Renal: Serum creatinine 0 ml/min Epatic: Serum bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: Creatinine clearance of below 30 ml/min Patients with a history of other malignancies within 2 years prior to study entry, except for adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage localized prostate cancer treated surgically with curative intent; good prognosis DCIS of the breast treated with lumpectomy alone with curative intent. Patients with a history of severe cardiac disease; e.g. NYHA Functional Class III or IV heart failure, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, or unstable angina. Other known co-morbidity with the potential to dominate survival Hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies or any of the applied drugs Pregnant or breast feeding women Any co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess treatment response (according to Response Evaluation Criteria In Solid Tumors [RECIST]) in patients with previous untreated wt RAS advanced colorectal cancer using mFOLFOX6 or FOLFIRI and cetuximab with therapy chosen using ERCC-1 gene expression assessment. ;Secondary Objective: To establish the feasibility of conducting a biomarker based trial of ERCC-1, in wt RAS mCRC patients in the cooperative group setting to assess progression free survival (PFS) and overall survival (OS) intients with biomarker directed treatment Description of group differences between ERCC-1 low and ERCC-1 high patients with respect to response rate, PFS and OS Description of group differences between ERCC-1 low and ERCC-1 high patients with respect to RAS status Secondary resection rate Molecular markers for toxicity To assess toxicity ;Primary end point(s): To assess treatment response (according to Response Evaluation Criteria In Solid Tumors [RECIST]) [1] in patients with previous untreated wt RAS advanced colorectal cancer using FOLFOX or FOLFIRI and cetuximab with therapy chosen using ERCC-1 gene expression assessment. ;Timepoint(s) of evaluation of this end point: end of the study	—

Measure

Time frame

Main Objective: To assess treatment response (according to Response Evaluation Criteria In Solid Tumors [RECIST]) in patients with previous untreated wt RAS advanced colorectal cancer using mFOLFOX6 or FOLFIRI and cetuximab with therapy chosen using ERCC-1 gene expression assessment. ;Secondary Objective: To establish the feasibility of conducting a biomarker based trial of ERCC-1, in wt RAS mCRC patients in the cooperative group setting to assess progression free survival (PFS) and overall survival (OS) intients with biomarker directed treatment Description of group differences between ERCC-1 low and ERCC-1 high patients with respect to response rate, PFS and OS Description of group differences between ERCC-1 low and ERCC-1 high patients with respect to RAS status Secondary resection rate Molecular markers for toxicity To assess toxicity ;Primary end point(s): To assess treatment response (according to Response Evaluation Criteria In Solid Tumors [RECIST]) [1] in patients with previous untreated wt RAS advanced colorectal cancer using FOLFOX or FOLFIRI and cetuximab with therapy chosen using ERCC-1 gene expression assessment. ;Timepoint(s) of evaluation of this end point: end of the study

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Secondary

Measure	Time frame
Secondary end point(s): To establish the feasibility of conducting a biomarker based trial of ERCC-1, in wt RAS mCRC patients in the cooperative group settingTo assess progression free survival (PFS) and overall survival (OS) intients with biomarker directed treatment Description of group differences between ERCC-1 low and ERCC-1 highpatients with respect to response rate, PFS and OS secondary resection rate Molecular markers for toxicity To assess toxicity ;Timepoint(s) of evaluation of this end point: end of the study	—

Measure

Time frame

Secondary end point(s): To establish the feasibility of conducting a biomarker based trial of ERCC-1, in wt RAS mCRC patients in the cooperative group settingTo assess progression free survival (PFS) and overall survival (OS) intients with biomarker directed treatment Description of group differences between ERCC-1 low and ERCC-1 highpatients with respect to response rate, PFS and OS secondary resection rate Molecular markers for toxicity To assess toxicity ;Timepoint(s) of evaluation of this end point: end of the study

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Countries

Austria

Contacts

Public ContactDr. Daniela Wolkersdorfer

Arbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH

d.wolkersdorfer@agmt.at00436641422504

Outcome results

None listed

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