Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
173 participants
INTERVENTIONAL
2012-05-31
2019-03-31
Brief Summary
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All patients will be randomized to biweekly cetuximab 500 mg/m2 in combination with arm A) FOLFIRI (irinotecan 180 mg/m2 IV, leucovorin: 400 mg/m2 IV, 5FU bolus: 400 mg/m2 IV and 46 hours 5FU infusion of 2400 mg/m2 every 2 weeks) or arm B) FOLFIRI alternating with FOLFOX6 (Oxaliplatin: 85 mg/m2 IV, leucovorin: 400 mg/m2 IV, 5FU bolus: 400 mg/m2 IV and 46 hours 5FU infusion of 2400 mg/m2 every 2 weeks) .
Primary objective: response rate (RECIST 1.1) in patients with with potential resectable KRAS wildtype metastatic colorectal cancer.
Secondary objectives: Resection rate, PFS, OS, Quality of life, tolerability. Biomarker evaluation to measure plasma biomarkers, Tumour blocks and sequential serum and plasma will be collected to search for markers that may predict efficacy including respectability and safety.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
BASIC_SCIENCE
NONE
Study Groups
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Biweekly cetuximab with continuously FOLFIRI
Biweekly cetuximab 500 mg/m2 in combination with FOLFIRI (irinotecan 180 mg/m2 IV, leucovorin: 400 mg/m2 IV, 5FU bolus: 400 mg/m2 IV and 46 hours 5FU infusion of 2400 mg/m2 every 2 weeks)
Cetuximab
Irinotecan
Folinic Acid
Calcium Carbonate
Biweekly cetuximab with alternating FOLFIRI and mFOLFOX6
Biweekly cetuximab 500 mg/m2 in combination with FOLFIRI alternating with FOLFOX6 (Oxaliplatin: 85 mg/m2 IV, leucovorin: 400 mg/m2 IV, 5FU bolus: 400 mg/m2 IV and 46 hours 5FU infusion of 2400 mg/m2 every 2 weeks)
Cetuximab
Irinotecan
Oxaliplatin
Folinic Acid
Calcium Carbonate
Interventions
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Cetuximab
Irinotecan
Oxaliplatin
Folinic Acid
Calcium Carbonate
Eligibility Criteria
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Inclusion Criteria
* Histologically proven adenocarcinoma in the colon or rectum
* At least 1 measurable metastatic disease manifestation according to the RECIST criteria (version 1.1)
* Potentially completely resectable or potentially curable metastatic colorectal cancer as determined by the local MDT conference and that requires tumour shrinkage before resection is possible. The following definitions are indicative:
* 4 or more liver metastases (CRLeM) without extra-hepatic disease
* 2 or more lung metastases (CRLuM) without hepatic or extra-hepatic disease
* 1 or more CRLeM determined as "potentially resectable" (such as because of location) by the local MDT.
* 1 or more CRLuM determined by the local MDT as potentially resectable (such as because of location).
* Non-resectable primary disease with resectable CRLeM or CRLuM.
KRAS and BRAF status:
\- Tumour tissue (primary or metastasis) typed as wild-type KRAS AND wild-type BRAF
General conditions:
* age \> 18 years
* WHO performance status ≤ 1
* expected survival \> 3 months
* sufficient bone-marrow function (Hb ≥ 6.2 µmol/l/Hb \> 10 g/dl ANC ≥ 1.5 x 109/l, thrombocytes ≥ 100 x 109/l)
* sufficient kidney and liver function: total bilirubin ≤ 1.5 x upper normal limit, serum creatinine ≤ 1.25 x upper normal limit, ALAT ≤ 3 x upper normal limit and ≤ 5 x upper normal limit with liver metastases
* the patient must have signed an informed declaration of consent before being registered; this must be documentable according to national guidelines
Exclusion Criteria
* previous chemotherapy for advanced/metastatic disease
* adjuvant chemotherapy unless completed more than 6 months before registration
* previous treatment with oxaliplatin or irinotecan
* previous treatment with cetuximab or other treatment for EGFR
* History of Inflammatory Bowel disease
* Severe or uncontrolled cardiovascular disease, congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction within the last twelve months, significant arrhythmias)
* Any condition that, according to the treating physician's judgement, could prevent the planned medical/surgical treatment from being carried out responsibly (such as uncontrolled active infection, known hypersensitivity or contra-indication for the planned treatment.
* Pregnant or breast-feeding women
* Patients of fertile age who do not want to use reliable contraception
18 Years
80 Years
ALL
No
Sponsors
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Merck Serono International SA
INDUSTRY
Per Pfeiffer
OTHER
Responsible Party
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Per Pfeiffer
Professor, MD, PhD
Principal Investigators
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Per Pfeiffer, Professor, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Odense University Hospital
Halfdan Sørbye, Professor, MD
Role: PRINCIPAL_INVESTIGATOR
Haukeland University Hospital
Bengt Glimelius, Professor, MD
Role: PRINCIPAL_INVESTIGATOR
Akademiske Sygehus, Uppsala University
Locations
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Aalborg University Hospital
Aalborg, , Denmark
Aarhus University Hospital
Aarhus, , Denmark
Rigshospitalet
Copenhagen, , Denmark
Sydvestjysk Hospital
Esbjerg, , Denmark
Herlev University Hospital
Herlev, , Denmark
Herning Hospital
Herning, , Denmark
Naestved Hospital
Næstved, , Denmark
Odense University Hospital
Odense, , Denmark
Roskilde Hospital
Roskilde, , Denmark
Haukeland University Hospital
Bergen, , Norway
Trondheim University Hospital
Trondheim, , Norway
Akademiska University Hospital
Uppsala, , Sweden
Countries
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Other Identifiers
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Nordic 8
Identifier Type: -
Identifier Source: org_study_id