Colorectal CancerPhase 2CORE 2NCT00479752
Safety and Efficacy of Folfox4 + Weekly Cetuximab vs Folfox 4+Biweekly Cetuximab by Metastatic Colorectal Cancer
A Phase 2 study testing FOLFOX4 (Oxaliplatin), Cetuximab in people with Colorectal Cancer, run by Central European Cooperative Oncology Group at 24 sites in 13 countries.
Trial summary
To assess the efficacy of FOLFOX4 in combination with cetuximab, weekly and FOLFOX4 in combination with cetuximab, biweekly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- FOLFOX4 (Oxaliplatin), Cetuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 24 sitesin 13 countries
- Study dates
- Jan 2008to Nov 2015
- 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
- Signed written informed consent
- Male or female ≥ 18 years of age
- 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 unidimensionally by CT scan or MRI. (Target lesion(s) must not lie within an irradiated area)
- Karnofsky performance status of > 80 at study entry
Show all 10Show fewer
- Leucocytes ≥ 3.0 x 10 9/L and neutrophils ≥1.5 x 10 9/L, platelets ≥ 100 x 10 9/L, and hemoglobin ≥ 9 g/dL.
- Bilirubin ≥ 1.5 x ULN
- ASAT and ALAT ≤ 2.5 x ULN (≤5 x ULN if liver metastasis are present)
- Serum creatinine ≤ 1.5 x ULN
Who cannot join
- Brain metastasis (known or suspected)
- Previous chemotherapy for metastatic disease. Prior adjuvant chemotherapy is allowed if the chemotherapy treatment free interval is > 6 months.
- Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to study entry
- Concurrent 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
Show all 16Show fewer
- Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months
- Acute or subacute intestinal occlusion or history of inflammatory bowel disease
- Pre-existing neuropathy > grade 1. In case of prior oxaliplatin containing adjuvant chemotherapy: pre-existing neuropathy ≥ 1.
- Known grade 3 or 4 allergic reaction to any of the components of the treatment.
- Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for ≥ 5 years will be allowed to enter the trial)
- Pregnancy or lactation
- Inadequate contraception (male or female patients) if of childbearing or procreational potential
- Known drug abuse/ alcohol abuse
- Legal incapacity or limited legal capacity
- Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
Trial locations and contacts
24 sites in 13 countries.
24 sites in 13 countries
Croatia3 sites
University Hospital Centre Rijeka
Rijeka, 51000
University Hospital for Tumors
Zagreb
University Hospital Rebro
Zagreb
Hungary3 sites
Semmelweis Univ. Radiology Clinic
Budapest, 1082
National Medical Center
Budapest, 1135
Markusovsy Hospital
Szombathely, 39700
Austria2 sites
LKH Leoben, Abt. für Innere Medizin
Leoben, Styria, 8700
Medical University of Vienna
Vienna
Greece2 sites
AHEPA Hospital University Hospital Papageorgiou
Athens
General Hospital of Athens
Athens
Israel2 sites
Meir Medical Center
Kfar Saba
Oncology Division Sourasky Medical Center
Tel Aviv, 64239
Latvia2 sites
P. Stradins University Hospital
Riga, 1020
latvian Center of Oncology
Riga, 1079
Romania2 sites
Institutul Oncologic Bucuresti
Bucharest
Institutul Oncologic Ion Chiricuta
Cluj-Napoca
Serbia2 sites
Institute of Oncology and Radiology of Serbia
Belgrade, 11000
Institute of Oncology of Vojvodina
Kamenitz, 21204
Slovakia2 sites
National Cancer Institute
Bratislava, 83310
National Institute of Oncology
Bratislava
Bosnia and Herzegovina1 site
Institute of Oncology Sarajevo
Sarajevo
About this study
Official title: A Randomized, Open-label Phase II Study Evaluating the Efficacy and Safety of FOLFOX4 + Weekly Cetuximab Versus FOLFOX4+ Biweekly Cetuximab as First-line Therapy in Patients With Metastatic Colorectal Cancer.
To assess the efficacy of FOLFOX4 in combination with cetuximab, weekly and FOLFOX4 in combination with cetuximab, biweekly.
Read the detailed description
This multicenter randomized phase II study will enroll approximately 150 patients with metastatic Colorectal Cancer. Patients are randomized in Arm A(FOLFOX4 in combination with weekly Cetuximab) or Arm B (FOLFOX4 in combination with biweekly Cetuximab). Both efficacy and safety data will be collected. The investigator will assess response to treatment every 8 weeks based on the imaging.
Following permanent treatment cessation, patients will be followed-up for survival.
- Conditions
- Colorectal Cancer
- Being tested
- FOLFOX4 (Oxaliplatin), Cetuximab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFOX4 (Oxaliplatin), CetuximabDrug
Arm A FOLFOX4:
- Oxaliplatin 85 mg/m² d1
- Leucovorin 200 mg/m² d1+d2, followed by
- Bolus 5FU 400 mg/m², followed by
- Infusional 5FU 600 mg/m²,over 22 hours, every 2 weeks
Cetuximab is administered to arm A of the study as an infusion with initial dose 400 mg/m² in week 1 followed by weekly doses of 250 mg/m².
Arm B FOLFOX4:
- Oxaliplatin 85 mg/m² d1
- Leucovorin 200 mg/m² d1+d2, followed by
- Bolus 5FU 400 mg/m² , followed by
- Infusional 5FU 600 mg/m², over 22 hours, every 2 weeks
Cetuximab is administered to arm B of the study as infusions of 500 mg/m² every two weeks.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | FOLFOX4:
* Oxaliplatin 85 mg/m² d1
* Leucovorin 200 mg/m² d1+d2, followed by
* Bolus 5FU 400 mg/m², followed by
* Infusional 5FU 600 mg/m²,over 22 hours, every 2 weeks
Cetuximab is administered to arm A of the study as an infusion with initial dose 400 mg/m² in week 1 followed by weekly doses of 250 mg/m². Receives: Drug: FOLFOX4 (Oxaliplatin), Cetuximab |
| B | Active comparator | FOLFOX4:
* Oxaliplatin 85 mg/m² d1
* Leucovorin 200 mg/m² d1+d2, followed by
* Bolus 5FU 400 mg/m² , followed by
* Infusional 5FU 600 mg/m², over 22 hours, every 2 weeks
Cetuximab is administered to arm B of the study as infusions of 500 mg/m² every two weeks. Receives: Drug: FOLFOX4 (Oxaliplatin), Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of the trial is: • Objective response (CR/PR), as assessed by RECIST criteria
Objective response (partial or complete) will be assessed using RECIST criteria. The objective response rate (defined as the rate of subjects with complete response (CR) or partial response (PR)) will be estimated and associated exact two-sided 95% confidence limit (Clopper-Pearson) will be calculated. In addition to the estimates within each treatment group odds ratios and associated 95% CI will be calculated using the Cochran Mantel-Haenszel procedure.
Measured: The objective response rate - defined as the rate of subjects with complete response (CR) or partial response (PR)
Secondary outcomes (1)
• Progression Free Survival (PFS) • Overall survival • Safety/Adverse events Safety
Secondary objectives are the estimation of differences in PFS and overall survival.
Measured: he rate of subjects with complete response (CR) or partial response (PR)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2007 (estimated)
- Study startJan 2008
- Primary completionJun 2010
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central European Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tudor Ciuleanu, Prof. Dr., Principal investigator, Institutul Oncologic of Cluj
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00479752
- Sponsor's protocol ID
- CECOG /CORE 1.2.002
- Acronym
- CORE 2
- Status last verified
- Feb 2016
- First submitted
- 25 May 2007
- Last updated
- 18 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label Phase II Study Evaluating the Efficacy and Safety of FOLFOX4 + Weekly Cetuximab Versus FOLFOX4+ Biweekly Cetuximab as First-line Therapy in Patients With Metastatic Colorectal Cancer.
- ClinicalTrials.gov ID
- NCT00479752
- Acronym / sponsor ID
- CORE 2 / CECOG /CORE 1.2.002
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Central European Cooperative Oncology GroupUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 28 May 2007 (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.
To assess the efficacy of FOLFOX4 in combination with cetuximab, weekly and FOLFOX4 in combination with cetuximab, biweekly.
Detailed description
This multicenter randomized phase II study will enroll approximately 150 patients with metastatic Colorectal Cancer. Patients are randomized in Arm A(FOLFOX4 in combination with weekly Cetuximab) or Arm B (FOLFOX4 in combination with biweekly Cetuximab). Both efficacy and safety data will be collected. The investigator will assess response to treatment every 8 weeks based on the imaging.
Following permanent treatment cessation, patients will be followed-up for survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: FOLFOX4 (Oxaliplatin), CetuximabFOLFOX4: * Oxaliplatin 85 mg/m² d1 * Leucovorin 200 mg/m² d1+d2, followed by * Bolus 5FU 400 mg/m², followed by * Infusional 5FU 600 mg/m²,over 22 hours, every 2 weeks Cetuximab is administered to arm A of the study as an infusion with initial dose 400 mg/m² in week 1 followed by weekly doses of 250 mg/m². |
| B | Active comparator | Drug: FOLFOX4 (Oxaliplatin), CetuximabFOLFOX4: * Oxaliplatin 85 mg/m² d1 * Leucovorin 200 mg/m² d1+d2, followed by * Bolus 5FU 400 mg/m² , followed by * Infusional 5FU 600 mg/m², over 22 hours, every 2 weeks Cetuximab is administered to arm B of the study as infusions of 500 mg/m² every two weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed written informed consent
- Male or female ≥ 18 years of age
- 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 unidimensionally by CT scan or MRI. (Target lesion(s) must not lie within an irradiated area)
Key exclusion criteria (16 listed)
- Brain metastasis (known or suspected)
- Previous chemotherapy for metastatic disease. Prior adjuvant chemotherapy is allowed if the chemotherapy treatment free interval is > 6 months.
- Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to study entry
- Concurrent 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 |
|---|---|---|
| FOLFOX4 (Oxaliplatin), CetuximabArm A FOLFOX4: * Oxaliplatin 85 mg/m² d1 * Leucovorin 200 mg/m² d1+d2, followed by * Bolus 5FU 400 mg/m², followed by * Infusional 5FU 600 mg/m²,over 22 hours, every 2 weeks Cetuximab is administered to arm A of the study as an infusion with initial dose 400 mg/m² in week 1 followed by weekly doses of 250 mg/m². Arm B FOLFOX4: * Oxaliplatin 85 mg/m² d1 * Leucovorin 200 mg/m² d1+d2, followed by * Bolus 5FU 400 mg/m² , followed by * Infusional 5FU 600 mg/m², over 22 hours, every 2 weeks Cetuximab is administered to arm B of the study as infusions of 500 mg/m² every two weeks. | Drug | A, B |
Primary outcome
The primary endpoint of the trial is: • Objective response (CR/PR), as assessed by RECIST criteria
Time frame: The objective response rate - defined as the rate of subjects with complete response (CR) or partial response (PR)
Objective response (partial or complete) will be assessed using RECIST criteria. The objective response rate (defined as the rate of subjects with complete response (CR) or partial response (PR)) will be estimated and associated exact two-sided 95% confidence limit (Clopper-Pearson) will be calculated. In addition to the estimates within each treatment group odds ratios and associated 95% CI will be calculated using the Cochran Mantel-Haenszel procedure.
1 secondary outcome
• Progression Free Survival (PFS) • Overall survival • Safety/Adverse events Safety
Time frame: he rate of subjects with complete response (CR) or partial response (PR)
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 18 Feb 2016.
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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.
Tudor Ciuleanu, Prof. Dr. principal investigator
Institutul Oncologic of Cluj
24 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 FOLFOX4 (Oxaliplatin), Cetuximab in people with Colorectal Cancer, run by Central European Cooperative Oncology Group at 24 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 10 inclusion and 16 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 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Croatia, Hungary, Austria, Greece, Israel 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 primary endpoint of the trial is: • Objective response (CR/PR), as assessed by RECIST criteria (time frame: The objective response rate - defined as the rate of subjects with complete response (CR) or partial response (PR)). 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 18 Feb 2016.