Biomarker Directed Treatment in Metastatic Colorectal Cancer
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ClinicalTrials.gov Identifier: NCT01703390 |
Recruitment Status :
Completed
First Posted : October 10, 2012
Last Update Posted : December 21, 2020
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Condition or disease | Intervention/treatment | Phase |
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Metastatic Colorectal Cancer | Drug: FOLFIRI + Cetuximab Drug: modifiedFOLFOX6 + Cetuximab | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 47 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pilot Study: Biomarker Directed Treatment in Metastatic Colorectal Cancer |
Actual Study Start Date : | December 4, 2012 |
Actual Primary Completion Date : | February 23, 2018 |
Actual Study Completion Date : | July 3, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: ERCC-1 low
modifiedFOLFOX6 + Cetuximab oxaliplatin 85 mg/m2 on day 1, 15 q d29 for 6 cycles folinic acid (FA) 400 mg/m2 on days 1 and 15 and q d29 for 6 cycles fluorouracil (5-FU) 400 mg/m2 bolus day 1 + 2400 mg/m2 46-hour infusion on days 1, 2 and 15, 16 and q d29 for 6 cycles or until unacceptable toxicity Cetuximab will be administered as a 120- minute intravenous infusion at 500 mg/m2 on day 1 then 500 mg/m2 bi-weekly
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Drug: modifiedFOLFOX6 + Cetuximab |
Experimental: ERCC-1 high
FOLFIRI + Cetuximab irinotecan 180 mg/m² on day 1, 15 q d29 for 6 cycles folinic acid (FA)400 mg/m2 on days 1 and 15 and q d29 for 6 cycles fluorouracil (5-FU) 400 mg/m2 bolus + 2400 mg/m2 46-hour infusion on days 1, 2 and 15, 16 and q d29 for 6 cycles or until unacceptable toxicity Cetuximab will be administered as a 120- minute intravenous infusion at 500 mg/m2 on day 1 then 500 mg/m2 bi-weekly
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Drug: FOLFIRI + Cetuximab |
- Response [ Time Frame: 5 years ]Treatment response according to Response Evaluation Criteria In Solid Tumors [RECIST]
- Progression free survival (PFS) [ Time Frame: 5 years ]
- Response rate [ Time Frame: 5 years ]Description of group differences between ERCC-1 low and ERCC-1 high patients with respect to response rate, PFS and OS
- Patient characteristics [ Time Frame: 5 years ]Description of group differences between ERCC-1 low and ERCC-1 high patients with respect to KRAS status
- Secondary resection rate [ Time Frame: 5 years ]
- Molecular markers for toxicity [ Time Frame: 5 years ]
- Number of adverse events during study treatment [ Time Frame: 5 years ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
1.1 Inclusion criteria for pre-screening phase:
- Untreated advanced metastatic colorectal cancer patients
- Adequate tissue to evaluate for genotyping (10 x 10µm thick formalin fixed paraffin embedded tissue sections and one corresponding HE stained slide or a FFPE tumor block)
1.2 Inclusion criteria for treatment phase:
Patients must fulfill all criteria listed below prior to enrolment in the study:
- Untreated wild-type KRAS metastatic colorectal cancer
- Previous adjuvant therapy must have been completed > 6 months before therapy initiation on this study
- Age >18 years
- Measureable disease with CT or MRI
- ECOG performance status of 0-2
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Adequate organ function
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Hematologic:
- Absolute neutrophil count > 1,500/µL
- Hemoglobin >9 mg/dl
- Platelet count >100,000 /µl
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Renal:
- Serum creatinine <1.5 x Upper limit of normal (UPN) or estimated clearance > 30 ml/min
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Hepatic:
- Serum bilirubin < 1.5 mg/dl
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Exclusion Criteria:
- Creatinine clearance 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01703390
Austria | |
KUK Linz - Med Campus III.: Univ.-Klinik für Hämatologie und Internistische Onkologie | |
Linz, Oberösterreich, Austria, 4021 | |
A.ö. Bezirkskrankenhaus Kufstein, Innere Medizin / Hämatologie / Onkologie | |
Kufstein, Tirol, Austria, 6330 | |
LKH Feldkirch, Interne E | |
Feldkirch, Vorarlberg, Austria, 6807 | |
LKH Bludenz Innere Medizin | |
Bludenz, Austria, 6700 | |
LKH Bregenz | |
Bregenz, Austria, 6900 | |
KH Dornbirn, Innere Medizin | |
Dornbirn, Austria, 6850 | |
Universitätsklinikum Graz | |
Graz, Austria, 8036 | |
LKH Hohenems, Interne Intensivmedizin | |
Hohenems, Austria, 6845 | |
Krankenhaus d. Barmherzigen Schwestern Linz | |
Linz, Austria, A-4010 | |
Universitätsklinik für Innere Medizin III mit Hämatologie, internistischer Onkologie, Infektologie, Rheumatologie und Onkologisches Zentrum | |
Salzburg, Austria, 5020 | |
Medizinische Universität Wien, Univ.Klinik für Innere Medizin I, Abteilung für Onkologie | |
Vienna, Austria, 1090 |
Principal Investigator: | Thomas Winder, MD | LKH Feldkirch, Interne E |
Responsible Party: | Arbeitsgemeinschaft medikamentoese Tumortherapie |
ClinicalTrials.gov Identifier: | NCT01703390 |
Other Study ID Numbers: |
AGMT_ERCC1 2011-003217-41 ( EudraCT Number ) |
First Posted: | October 10, 2012 Key Record Dates |
Last Update Posted: | December 21, 2020 |
Last Verified: | December 2020 |
metastatic colorectal cancer mCRC ERCC-1 ERCC1 AGMT |
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases |
Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Cetuximab Antineoplastic Agents, Immunological Antineoplastic Agents |