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Nordic 8 - A Phase II Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01867697
Recruitment Status : Active, not recruiting
First Posted : June 4, 2013
Last Update Posted : August 27, 2018
Sponsor:
Collaborator:
Merck Serono International SA
Information provided by (Responsible Party):
Per Pfeiffer, Odense University Hospital

Brief Summary:

Nordic randomized phase II trial which evaluates whether biweekly cetuximab with alternating FOLFIRI and mFOLFOX6 is more effective than biweekly cetuximab with continuously FOLFIRI in patients with potential resectable KRAS wildtype metastatic colorectal cancer.

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.


Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: Cetuximab Drug: Irinotecan Drug: Oxaliplatin Drug: Folinic Acid Drug: Calcium Carbonate Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Potentially Resectable Metastatic Colorectal Cancer With Wild-type KRAS and BRAF: Alternating Chemotherapy Plus Cetuximab - A Randomised Phase II Trial
Study Start Date : May 2012
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arm Intervention/treatment
Active Comparator: 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)
Drug: Cetuximab
Drug: Irinotecan
Drug: Folinic Acid
Drug: Calcium Carbonate
Experimental: 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)
Drug: Cetuximab
Drug: Irinotecan
Drug: Oxaliplatin
Drug: Folinic Acid
Drug: Calcium Carbonate



Primary Outcome Measures :
  1. Response rate (RR) [ Time Frame: March 2015 (up to 3 years) ]

Secondary Outcome Measures :
  1. Survival (Overall survival) [ Time Frame: June 2016 (up to 5 years) ]
  2. Frequency of secondary surgical resection (R0 + R1 + R2 resections) [ Time Frame: January 2015 (up to 3 years) ]
  3. Frequency of secondary micro-radical surgical resection (R0 resection) [ Time Frame: March 2015 (up to 3 years) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Histology and stages:

  • 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 treatment:

  • 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

Information from the National Library of Medicine

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): NCT01867697


Locations
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Denmark
Aalborg University Hospital
Aalborg, Denmark, 9100
Aarhus University Hospital
Aarhus, Denmark, 8000
Rigshospitalet
Copenhagen, Denmark, 2100
Sydvestjysk Hospital
Esbjerg, Denmark, 6700
Herlev University Hospital
Herlev, Denmark, 2730
Herning Hospital
Herning, Denmark
Naestved Hospital
Naestved, Denmark, 4700
Odense University Hospital
Odense, Denmark, 5000
Roskilde Hospital
Roskilde, Denmark, 4000
Norway
Haukeland University Hospital
Bergen, Norway, 5021
Trondheim University Hospital
Trondheim, Norway
Sweden
Akademiska University Hospital
Uppsala, Sweden, 751 85
Sponsors and Collaborators
Per Pfeiffer
Merck Serono International SA
Investigators
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Principal Investigator: Per Pfeiffer, Professor, MD, PhD Odense University Hospital
Principal Investigator: Halfdan Sørbye, Professor, MD Haukeland University Hospital
Principal Investigator: Bengt Glimelius, Professor, MD Akademiske Sygehus, Uppsala University
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Responsible Party: Per Pfeiffer, Professor, MD, PhD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01867697    
Other Study ID Numbers: Nordic 8
First Posted: June 4, 2013    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Leucovorin
Folic Acid
Oxaliplatin
Irinotecan
Cetuximab
Calcium Carbonate
Levoleucovorin
Physiological Effects of Drugs
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients