Metastatic Colorectal CancerPhase 2NCT00660582
FLOX + Cetuximab (Erbitux®) for Patients With Metastatic Colorectal Cancer and Wild Type K-RAS Tumor
A Phase 2 study testing Cetuximab (Erbitux) and Oxaliplatin (Eloxatin) + Fluorouracil + folinic acid in people with Metastatic Colorectal Cancer, run by Per Pfeiffer at 6 sites in 3 countries.
Trial summary
The Nordic FLOX-regime consists of a combination of bolus 5-FU, leukovorin and oxaliplatin (Eloxatin®). Cetuximab (Erbitux®) is an antibody against the epidermal growth factor receptor (EGFR). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Cetuximab (Erbitux) and Oxaliplatin (Eloxatin) + Fluorouracil + folinic acid
- Type of treatment
- Injection or infusion
- How many people
- 152 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Apr 2008to Feb 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histology and staging disease:
- Histological proven adenocarcinoma of the colon or rectum
- At least one measurable metastatic lesion according to RECIST criteria
- If only one metastatic lesion, histology is mandatory
- Mutation level:
- Tumor tissue (primary or metastasis) typological classified as K-RAS wildtype in codon 12 and 13 in exon 1 at real-time PCR
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- General conditions:
- Age >18 and < 75 years
- WHO performance status ≤ 2; life expectancy of more than 3 months
- Adequate haematological function: (Hb ≥ 6.2 μmol/d, ANC ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L)
- Adequate renal and hepatic functions: total bilirubin ≤ 1.5 upper normal limit, creatinine ≤ 1.25 × upper normal limit, ALAT ≤ 3 x upper normal limits, and ≤ 5 x upper normal limits in case of liver metastases
- Written informed consent prior to randomisation must be obtained and documented according to the local regulatory requirements
- Other:
- Fertile patients must use adequate contraceptives
Who cannot join
- Prior therapy:
- Prior chemotherapy for advanced/metastatic disease
- Adjuvant chemotherapy must have ended > 6 months before inclusion
- Prior treatment with Eloxatin
- Prior treatment with Erbitux or other treatment to EGFR
- Prior or current history:
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- Current indication for resection with a curative intent
- Evidence of CNS metastasis
- Current infection, unresolved bowel obstruction or subobstruction, uncontrolled Crohn's disease or ulcerative colitis
- Current history of chronic diarrhea
- Peripheral neuropathy
- Other serious illness or medical conditions (including contraindication to 5 FU e.g.: angor, myocardial infarction within 6 months, contraindications to monoclonal antibodies)
- Past or concurrent history of malignant neoplasm other than colorectal adenocarcinoma within the past five years, except curatively treated non melanoma skin cancer or in situ carcinoma of the cervix
- Concomitant treatments:
- Concomitant (or within 4 weeks before randomisation) administration of any other experimental drug under investigation
- Concurrent treatment with any other anti-cancer therapy
- Other:
- Pregnant or breast feeding women
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Denmark3 sites
Department of Oncology, Aalborg University Hospital
Aalborg, 9800
Department of Oncology, Herlev University Hospital
Herlev, 2630
Department of Oncology, Odense University Hospital
Odense, 5000
Norway2 sites
Department of Oncology, Haukeland University Hospital
Bergen
Kreftsenteret, Ullevaal University Hospital
Oslo, 0407
About this study
Official title: FLOX + Cetuximab (Erbitux®): First Line Treatment for Patients With Metastatic Colorectal Cancer and Wild Type K-RAS Tumor, A Phase II Study
The Nordic FLOX-regime consists of a combination of bolus 5-FU, leukovorin and oxaliplatin (Eloxatin®). Cetuximab (Erbitux®) is an antibody against the epidermal growth factor receptor (EGFR). The combination of FLOX and weekly Erbitux has been investigated in the Nordic VII study where 571 patients were randomized to FLOX (regime A) or FLOX + Erbitux (regime B or C). Effect-data has not yet been published but the combination is well tolerated, and other studies have shown that Erbitux administered with chemotherapy seem to be more efficient than chemotherapy alone.
The main purpose with this study is to investigate the effect of FLOX and Erbitux given every second week as first line treatment for patients with metastatic colorectal cancer and K-RAS wildtype tumor.
The latest accessible data regarding treatment towards EGFR and K-RAS mutations shows that patients with K-RAS wildtype responds better to treatment than patients with K-RAS mutations.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Cetuximab (Erbitux), Oxaliplatin (Eloxatin) + Fluorouracil + folinic acid
- Keywords
- Erbitux, Colorectal cancer, Oxaliplatin, Flox, Fluorouracil + folinic acid, K-RAS
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetuximab (Erbitux)Drug
500 mg/m² every second week, intravenous infusion, 8 cycles
Oxaliplatin (Eloxatin) + Fluorouracil + folinic acidDrug
Given in combination day 1 and 2, every second week, 8 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionMay 2011
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Per Pfeiffer
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital
- Responsible party
- Sponsor-investigator, Per Pfeiffer, Odense University Hospital
- Investigators
- Per Pfeiffer, MD, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00660582
- Sponsor's protocol ID
- Nordic 7.5
- Status last verified
- Jan 2015
- First submitted
- 11 Apr 2008
- Last updated
- 21 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FLOX + Cetuximab (Erbitux®): First Line Treatment for Patients With Metastatic Colorectal Cancer and Wild Type K-RAS Tumor, A Phase II Study
- ClinicalTrials.gov ID
- NCT00660582
- Acronym / sponsor ID
- Nordic 7.5
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Erbitux, Colorectal cancer, Oxaliplatin, Flox, Fluorouracil + folinic acid, K-RAS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Per PfeifferUniversity, hospital or other
- Collaborators
- Odense University Hospital
- Study start
- Apr 2008
- Primary completion
- May 2011 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 17 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Nordic FLOX-regime consists of a combination of bolus 5-FU, leukovorin and oxaliplatin (Eloxatin®). Cetuximab (Erbitux®) is an antibody against the epidermal growth factor receptor (EGFR). The combination of FLOX and weekly Erbitux has been investigated in the Nordic VII study where 571 patients were randomized to FLOX (regime A) or FLOX + Erbitux (regime B or C). Effect-data has not yet been published but the combination is well tolerated, and other studies have shown that Erbitux administered with chemotherapy seem to be more efficient than chemotherapy alone.
The main purpose with this study is to investigate the effect of FLOX and Erbitux given every second week as first line treatment for patients with metastatic colorectal cancer and K-RAS wildtype tumor.
The latest accessible data regarding treatment towards EGFR and K-RAS mutations shows that patients with K-RAS wildtype responds better to treatment than patients with K-RAS mutations.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histological proven adenocarcinoma of the colon or rectum
- At least one measurable metastatic lesion according to RECIST criteria
- If only one metastatic lesion, histology is mandatory
- Tumor tissue (primary or metastasis) typological classified as K-RAS wildtype in codon 12 and 13 in exon 1 at real-time PCR
- Age >18 and < 75 years
Key exclusion criteria (18 listed)
- Prior chemotherapy for advanced/metastatic disease
- Adjuvant chemotherapy must have ended > 6 months before inclusion
- Prior treatment with Eloxatin
- Prior treatment with Erbitux or other treatment to EGFR
- Current indication for resection with a curative intent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cetuximab (Erbitux)500 mg/m² every second week, intravenous infusion, 8 cycles | Drug | – |
| Oxaliplatin (Eloxatin) + Fluorouracil + folinic acidGiven in combination day 1 and 2, every second week, 8 cycles | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Pfeiffer, MD principal investigator
Odense University Hospital
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cetuximab (Erbitux) and Oxaliplatin (Eloxatin) + Fluorouracil + folinic acid in people with Metastatic Colorectal Cancer, run by Per Pfeiffer at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark, Norway, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2015.