Metastatic Colorectal CancerPhase 2NCT00286130
Safety and Efficacy of Folfox6 + Cetuximab Versus Folfiri +Cetuximab in Patients With Metastatic Colorectal Cancer
A Phase 2 study testing Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan, FOLFOX 6 and FOLFIRI in people with Metastatic Colorectal Cancer, run by Central European Cooperative Oncology Group at 27 sites in 13 countries.
Trial summary
In Patients with metastatic colorectal cancer the following treatments first-line Folfiri+Cetuximab first-line Folfox6 + Cetuximab will be concerning efficacy and safety. The trial compares Folfiri + Cetuximab and Folfox6 + Cetuximab concerning efficacy and safety as first Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan, FOLFOX 6 and FOLFIRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 27 sitesin 13 countries
- Study dates
- Jul 2005to Oct 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
- Metastatic colorectal carcinoma not suitable for curative-intent resection
- Availability of tumor sample (or able and willing to provide tumor sample) for EGFR assessment
- Presence of at least one lesion measurable unidimensional by CT scan or MRI (Target lesion(s) must not lie within an irradiated area)
- ECOG performance status of < 2 at study entry
Who cannot join
- Brain metastasis (known or suspected)
- Previous chemotherapy for metastatic CRC or adjuvant therapy with oxaliplatin or irinotecan. Adjuvant therapy with 5 FU or derivatives is allowed if the chemotherapy treatment free interval is > 6 months
- Surgery (excluding diagnostic biopsy) or irritation within 4 weeks prior to study entry
- Cocurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
- Any investigational agent(s) within 4 weeks prior to entry
- Previous exposure to EGFR-pathway targeting therapy
Trial locations and contacts
27 sites in 13 countries.
27 sites in 13 countries
Portugal5 sites
Hospital Amadora Sintra, Servico de Oncologia
Amadora, 2720
Hospital de Beja
Beja, 78000
Hospital Distrital de Faro
Faro, 8000-386
Hospital Geral de Sto. António
Porto, 4000-377
Hospital San Teotóno -
Viseu
Hungary3 sites
National Medical Center
Budapest, 1135
Markusovsy Hospital
Szomathely, 39700
Csolnoky Ferenc County Hospital
Veszprém, 8200
Turkey (Türkiye)3 sites
Ankara Hacettepe University, Oncology Unit
Ankara
Gazi University Medical Faculty
Ankara
9 Eyul University Medical Faculty, Dep of Oncology
Izmir
Austria2 sites
LKH Leoben, Abt. für Innere Medizin
Leoben, Styria, 8700
Univ. Klinik für Innere Medizin I
Vienna, 1090
Bulgaria2 sites
University Hospital "Queen Joanna"
Sofia, 1504
SBALO National Oncology Center
Sofia, 1754
Croatia2 sites
University Hospital for Tumors
Zagreb
University Hospital Rebro
Zagreb
Czechia2 sites
Univ. Hospital Brno, Dept. Of Clinical Oncology
Brno, 62500
Charles University Prague, Dep. of Oncology
Prague, 12808
Israel2 sites
Hadassah Medical Center
Jerusalem
Souraski Medical Center
Tel Aviv
Romania2 sites
Institutul Oncologic Bucuresti
Bucharest
Institutul Oncologic Cluj
Cluj-Napoca, 400015
Bosnia and Herzegovina1 site
Institute of Oncology
Sarajevo, 71000
About this study
Official title: A Randomised, Open-label Phase II Study Evaluating the Efficacy and Safety of Folfox6 + Cetuximab as First-line Therapy in Patients With Metastatic Colorectal Cancer
In Patients with metastatic colorectal cancer the following treatments first-line Folfiri+Cetuximab first-line Folfox6 + Cetuximab will be concerning efficacy and safety.
The trial compares Folfiri + Cetuximab and Folfox6 + Cetuximab concerning efficacy and safety as first
Read the detailed description
The multicenter randomized phase II study will enroll a target of approximately 150 first-line patients with metastatic CRC.
EGFR expression is not required for study entry, however, the EGFR status will be measured retrospectively.
Patients are randomized to Arm A or Arm B. Arm A: FOLFOX 6 in combination with cetuximab Arm B: FOLFIRI in combination with cetuximab. Both efficacy and safety data will be collected. The investigators will assess response to treatment at 6 weeks, 12 weeks and thereafter every 12 weeks based on imaging Following permanent treatment cessation (stop of all study treatments) patients will be followed-up for.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan, FOLFOX 6, FOLFIRI
- Keywords
- metastatic colorectal cancer, FOLFOX 6, FOLFIRI
- 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, Oxaliplatin, Leucovorin, 5FU, IrinotecanDrug
FOLFOX 6Drug
FOLFOX 6:
- Oxaliplatin 100 mg/m² d1 concurrent with
- Leucovorin 400 mg/m², followed by
- Bolus 5FU 400 mg/m² , followed by
- Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks:
FOLFIRIDrug
FOLFIRI:
- Irinotecan 180 mg/m² day 1 concurrent with
- Leucovorin 400 mg/m² followed by
- Bolus 5FU 400 mg/m², followed by
- Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| FOLFOX 6 | Active comparator | FOLFOX 6:
* Oxaliplatin 100 mg/m² d1 concurrent with
* Leucovorin 400 mg/m², followed by
* Bolus 5FU 400 mg/m² , followed by
* Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks: Receives: Drug: Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan; Drug: FOLFOX 6 |
| FOLFIRI | Active comparator | FOLFIRI:
* Irinotecan 180 mg/m² day 1 concurrent with
* Leucovorin 400 mg/m² followed by
* Bolus 5FU 400 mg/m², followed by
* Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks Receives: Drug: Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan; Drug: FOLFIRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage of patients surviving without disease progression in each arm at 9 months
Secondary outcomes (4)
PFS rates at 3,6,12 months
Response rates
Overall survival (OS) in each arm
Safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2006 (estimated)
- Study startJul 2005
- Study completionOct 2007
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central European Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Werner Scheithauer, MD, Principal investigator, Dep. of Internal Medicine I, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00286130
- Sponsor's protocol ID
- CECOG/Core 1.2.001
- Other IDs
- EUDRACT number 2004-002391-42
- Status last verified
- Apr 2012
- First submitted
- 2 Feb 2006
- Last updated
- 1 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Open-label Phase II Study Evaluating the Efficacy and Safety of Folfox6 + Cetuximab as First-line Therapy in Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00286130
- Acronym / sponsor ID
- CECOG/Core 1.2.001
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- metastatic colorectal cancer, FOLFOX 6, FOLFIRI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Central European Cooperative Oncology GroupUniversity, hospital or other
- Study start
- Jul 2005
- Study completion
- Oct 2007 (actual)
- First posted
- 3 Feb 2006 (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.
In Patients with metastatic colorectal cancer the following treatments first-line Folfiri+Cetuximab first-line Folfox6 + Cetuximab will be concerning efficacy and safety.
The trial compares Folfiri + Cetuximab and Folfox6 + Cetuximab concerning efficacy and safety as first
Detailed description
The multicenter randomized phase II study will enroll a target of approximately 150 first-line patients with metastatic CRC.
EGFR expression is not required for study entry, however, the EGFR status will be measured retrospectively.
Patients are randomized to Arm A or Arm B. Arm A: FOLFOX 6 in combination with cetuximab Arm B: FOLFIRI in combination with cetuximab. Both efficacy and safety data will be collected. The investigators will assess response to treatment at 6 weeks, 12 weeks and thereafter every 12 weeks based on imaging Following permanent treatment cessation (stop of all study treatments) patients will be followed-up for.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FOLFOX 6 | Active comparator | Drug: Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan, Drug: FOLFOX 6FOLFOX 6: * Oxaliplatin 100 mg/m² d1 concurrent with * Leucovorin 400 mg/m², followed by * Bolus 5FU 400 mg/m² , followed by * Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks: |
| FOLFIRI | Active comparator | Drug: Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan, Drug: FOLFIRIFOLFIRI: * Irinotecan 180 mg/m² day 1 concurrent with * Leucovorin 400 mg/m² followed by * Bolus 5FU 400 mg/m², followed by * Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
- Metastatic colorectal carcinoma not suitable for curative-intent resection
- Availability of tumor sample (or able and willing to provide tumor sample) for EGFR assessment
- Presence of at least one lesion measurable unidimensional by CT scan or MRI (Target lesion(s) must not lie within an irradiated area)
- ECOG performance status of < 2 at study entry
Key exclusion criteria (6 listed)
- Brain metastasis (known or suspected)
- Previous chemotherapy for metastatic CRC or adjuvant therapy with oxaliplatin or irinotecan. Adjuvant therapy with 5 FU or derivatives is allowed if the chemotherapy treatment free interval is > 6 months
- Surgery (excluding diagnostic biopsy) or irritation within 4 weeks prior to study entry
- Cocurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
- Any investigational agent(s) within 4 weeks prior to entry
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, Oxaliplatin, Leucovorin, 5FU, Irinotecan | Drug | FOLFIRI, FOLFOX 6 |
| FOLFOX 6FOLFOX 6: * Oxaliplatin 100 mg/m² d1 concurrent with * Leucovorin 400 mg/m², followed by * Bolus 5FU 400 mg/m² , followed by * Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks: | Drug | FOLFOX 6 |
| FOLFIRIFOLFIRI: * Irinotecan 180 mg/m² day 1 concurrent with * Leucovorin 400 mg/m² followed by * Bolus 5FU 400 mg/m², followed by * Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks | Drug | FOLFIRI |
Primary outcome
the percentage of patients surviving without disease progression in each arm at 9 months
4 secondary outcomes
PFS rates at 3,6,12 months
Response rates
Overall survival (OS) in each arm
Safety
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 1 May 2012.
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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.
Werner Scheithauer, MD principal investigator
Dep. of Internal Medicine I, Medical University of Vienna
27 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan, FOLFOX 6 and FOLFIRI in people with Metastatic Colorectal Cancer, run by Central European Cooperative Oncology Group at 27 sites in 13 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 5 inclusion and 6 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 1 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Portugal, Hungary, Turkey (Türkiye), Austria, Bulgaria and 8 more countries. 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.
What does the primary outcome measure?
the percentage of patients surviving without disease progression in each arm at 9 months. It is what the study was designed to measure, not a finding.
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 1 May 2012.