Colorectal CancerPhase 2NCT00153998
Cetuximab in Neoadjuvant Treatment of Non-Resectable Colorectal Liver Metastases (CELIM)
A Phase 2 study testing Cetuximab, Liver resection and Cetuximab and FOLFIRI in people with Colorectal Cancer and Liver Metastases, run by Technische Universität Dresden at 21 sites in 2 countries.
Trial summary
General Objectives: To test the feasibility of neoadjuvant treatment with cetuximab/chemotherapy followed by liver resection To determine the optimal combination (cetuximab/FOLFOX versus cetuximab/FOLFIRI) for further trials in preoperative chemotherapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Liver Metastases
- What is being tested?
- Cetuximab, Liver resection and Cetuximab and FOLFIRI
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 21 sitesin 2 countries
- Study dates
- Nov 2004to Mar 2008
- 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
- Patients with non-resectable, histologically confirmed, synchronous or metachronous colorectal liver metastases. Patients with non-resectable metastases are defined as; patients with five or more liver metastases; and/or patients with liver metastases that are technically non-resectable (local surgeon in cooperation with local radiologist will define non-resectability on the basis of remaining functional liver tissue, infiltration of all liver veins, infiltration of both liver arteries, both portal branches or both bile ducts).
- Patients with simultaneous liver metastases are eligible, if the primary tumor has been resected at least 1 month prior to chemotherapy.
- Karnofsky Performance Status ≥ 80
- Informed consent
- Adequate bone marrow function, liver and renal function (neutrophils > 1.5 x 10^9/l; thrombocytes > 100 x 10^9/l; hemoglobin > 8.0 g/l; bilirubin ≤ 1.5 x upper limit of normal [ULN] and not increasing more than 25% within the last 4 weeks; ALAT and ASAT < 5 x UNL; serum creatinine ≤ 1.5 x UNL)
- Age ≥ 18 years
Who cannot join
- Any evidence of extrahepatic metastases, lymph node metastases and primary tumor recurrence
- Prior chemotherapy (except adjuvant chemotherapy with an interval of ≥ 6 months)
- Previous exposure to EGFR (epidermal growth factor receptor)-targeting therapy
- Radiotherapy or major abdominal or thoracic surgery (excluding diagnostic biopsy or port implantation) ≤ 4 weeks before study entry
- Concurrent systemic immune therapy, chemotherapy, or hormone therapy
- Investigational agents or participation in clinical trials within 30 days before start of the treatment in study
Show all 13Show fewer
- Clinically relevant coronary disease or myocardial infarction within 12 months before study entry
- Peripheral neuropathy > CTC grade I
- Inflammatory bowel disease
- Previous malignancy (except colorectal cancer, history of basal cell carcinoma of skin or pre-invasive carcinoma of the cervix with adequate treatment)
- History of severe psychiatric illness
- Drug or alcohol abuse
- Breast feeding or pregnant women, no effective contraception if risk of conception exists (male and female patients)
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
Germany20 sites
Kreiskrankenhaus Aschersleben
Aschersleben, 06449
Charite-Campus Benjamin Franklin, Innere Medizin
Berlin, 12200
Charite-Campus, Virchow-Klinikum, Innere Medizin
Berlin, 13353
Allgemeines Krankenhaus Celle
Celle, 29223
University Hospital "Carl Gustav Carus"
Dresden, 01307
Florence-Nightingale-Krankenhaus
Düsseldorf, 40489
Universitaet Erlangen-Nuernberg, Chirurgie
Erlangen, 91054
Westdeutsches Tumorzentrum, Universitaetsklinikum Essen
Essen, 45112
Johann Wolfgang Goethe Universitaet, Chirurgie
Frankfurt am Main, 60596
Westpfalz-Klinikum GmbH Innere Medizin I
Kaiserslautern, 67653
UKSH Campus Kiel, II. Medizinische Klinik
Kiel, 24116
Staedtisches Klinikum Magdeburg-Olvenstedt
Magdeburg, 39130
Universitaetsklinik Mannheim gGmbH, III. Medizinische Klinik
Mannheim, 68167
Klinikum Grosshadern, III. Medizinische Klinik
München, 81377
Klinikum Oldenburg GmbH
Oldenburg, 26133
Klinikum Passau, II. Medizinische Klinik
Passau, 94032
Klinikum der Hansestadt Stralsund GmbH, Medizinische Klinik
Stralsund, 18435
Krankenhaus der Barmherzigen Brueder Trier, Chirurgie
Trier, 54292
Universitaetsklinikum Tuebingen
Tübingen, 72076
Universitaetsklinikum Wuerzburg, Chirurgie
Würzburg, 97080
Austria1 site
Medizinische Universitaet Wien, Universitaetsklinik für Chirurgie
Vienna, A-1090
About this study
Official title: Open, Randomized, Multicenter, Randomized Phase II Trial Comparing the Combination of Cetuximab With Oxaliplatin/5-FU/FA Versus the Combination of Cetuximab With Irinotecan/5-FU/FA as Neoadjuvant Treatment in Patients With Non-Resectable Colorectal Liver Metastases
General Objectives:
- To test the feasibility of neoadjuvant treatment with cetuximab/chemotherapy followed by liver resection
- To determine the optimal combination (cetuximab/FOLFOX versus cetuximab/FOLFIRI) for further trials in preoperative chemotherapy
Read the detailed description
Patients with liver metastasis will be screened for this study. Eligible patients will complete the pretreatment evaluation including an abdominal CT scan that will be presented to the local surgeon and the radiologist for proving of resectability of hepatic lesions. Additionally, CT scans will be reviewed by three reference surgeons. In case of non-resectability, as defined above, CT- or ultrasound- guided biopsy of one of the liver metastases will be performed, unless biopsy material is available from prior biopsy of one of the liver metastases.
Instead of an ultrasound-guided biopsy, a CT-guided biopsy may be performed.
Formalin-fixed, paraffin embedded metastatic tissue will be sent to reference laboratory (Prof. Störkel, Wuppertal) for immunohistochemical analysis of EGFR- expression.
Additionally tissue will be stored in "RNA later" for gene expression analysis if agreed by the patient.
Additionally, the primary tumor will be collected and sent to the reference laboratory for analysis of EGFR- expression (if agreement of the patient exists).
Patients will be randomized to a combination of:
Cetuximab/FOLFIRI (irinotecan/5-FU/FA) or Cetuximab/FOLFOX6 (oxaliplatin/5-FU/FA)
All patients receive a four month treatment (eight cycles) of the allocated treatment.
Resection is planned after completion of neoadjuvant treatment and should be performed between 4 and 6 weeks after the last dose of chemotherapy. Probes of the resected material (in liquid nitrogen and paraffin embedded material will be collected).
If a resection is not possible after eight administrations of chemotherapy, chemotherapy will be continued until tumor progression (maximal duration of treatment 2 years) and the patient will be evaluated for a potential resection every two months.
After resection, postoperative treatment is planned for 3 months (6 cycles). Treatment start is planned between 4 and 8 weeks after the operation.
- Conditions
- Colorectal Cancer, Liver Metastases
- Being tested
- Cetuximab, Liver resection, Cetuximab and FOLFIRI, Cetuximab and FOLFOX
- Keywords
- Cetuximab, Oxaliplatin, Irinotecan, 5-FU, Chemotherapy, Resection, Liver resection, Neoadjuvant
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
Liver resectionProcedure or surgery
Cetuximab and FOLFIRIDrug
Also called Cetuximab(C225, Erbitux®, Merck KGaA), Irinotecan (irinotecan HCl, CPT-11 or Campto®, Aventis), 5-Fluorouracil (5-FU), Folinic acid (FA, i.e. Leucovorin®, Wyeth)
Cetuximab 400 mg/m² (2.0 h i.v.) (first dose only), followed by:
Cetuximab 250 mg/m² (1.0 h i.v.) weekly
Irinotecan 180 mg/m² (2.0 h i.v.) all compounds day 1, repeated at day 15 Folinic acid (D,L) 400 mg/m² (2.0 h i.v.) 5-FU 400 mg/m² (bolus i.v.) 5-FU 2400 (-3000) mg/m² (46 h i.v.)
Cetuximab and FOLFOXDrug
Also called Cetuximab(C225, Erbitux®, Merck KGaA), Oxaliplatin (L-OHP, Eloxatin®, Sanofi-Synthelabo), 5-Fluorouracil (5-FU), Folinic acid (FA, i.e. Leucovorin®, Wyeth)
Cetuximab 400 mg/m² (2.0 h i.v.) (first dose only), followed by:
Cetuximab 250 mg/m² (1.0 h i.v.) weekly
Oxaliplatin 100 mg/m² (2.0 h i.v.) all compounds day 1, repeated at day 15 Folinic acid (D,L) 400 mg/m² (2.0 h i.v.) 5-FU 400 mg/m² (bolus i.v.) 5-FU 2400 (-3000) mg/m² (46 h i.v.)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Cetuximab and FOLFIRI Receives: Drug: Cetuximab; Procedure: Liver resection; Drug: Cetuximab and FOLFIRI |
| 2 | Active comparator | Cetuximab and FOLFOX Receives: Drug: Cetuximab; Procedure: Liver resection; Drug: Cetuximab and FOLFOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response, defined as partial and complete response according to RECIST (Response Evaluation Criteria in Solid Tumors) - criteria in the intention-to-treat [ITT-] population
Secondary outcomes (6)
Rate of R0 liver resection (ITT- population)
Progression free survival (ITT- population)
Disease free survival after resection (ITT- population)
Overall survival (ITT- population)
Safety (all patients that received any study drug)
Molecular predictive markers for response and toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startNov 2004
- Primary completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- 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
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Investigators
- Claus-Henning Köhne, Prof. Dr., Principal investigator, Klinikum Oldenburg GmbH, Dr.-Eden-Str.10; 26133 OldenburgGunnar Folprecht, Dr., Principal investigator, University Hospital Dresden, Fetscherstr. 74, 01307 Dresden, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00153998
- Sponsor's protocol ID
- CELIM
- Status last verified
- Apr 2007
- First submitted
- 8 Sep 2005
- Last updated
- 27 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Folprecht G, Gruenberger T, Bechstein W, Raab HR, Weitz J, Lordick F, Hartmann JT, Stoehlmacher-Williams J, Lang H, Trarbach T, Liersch T, Ockert D, Jaeger D, Steger U, Suedhoff T, Rentsch A, Kohne CH. Survival of patients with initially unresectable colorectal liver metastases treated with FOLFOX/cetuximab or FOLFIRI/cetuximab in a multidisciplinary concept (CELIM study). Ann Oncol. 2014 May;25(5):1018-25. doi: 10.1093/annonc/mdu088. Epub 2014 Feb 27.
PubMed 24585720Folprecht G, Gruenberger T, Bechstein WO, Raab HR, Lordick F, Hartmann JT, Lang H, Frilling A, Stoehlmacher J, Weitz J, Konopke R, Stroszczynski C, Liersch T, Ockert D, Herrmann T, Goekkurt E, Parisi F, Kohne CH. Tumour response and secondary resectability of colorectal liver metastases following neoadjuvant chemotherapy with cetuximab: the CELIM randomised phase 2 trial. Lancet Oncol. 2010 Jan;11(1):38-47. doi: 10.1016/S1470-2045(09)70330-4. Epub 2009 Nov 26.
PubMed 19942479
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Randomized, Multicenter, Randomized Phase II Trial Comparing the Combination of Cetuximab With Oxaliplatin/5-FU/FA Versus the Combination of Cetuximab With Irinotecan/5-FU/FA as Neoadjuvant Treatment in Patients With Non-Resectable Colorectal Liver Metastases
- ClinicalTrials.gov ID
- NCT00153998
- Acronym / sponsor ID
- CELIM
- Conditions
- Colorectal Cancer, Liver Metastases
- Keywords
- Cetuximab, Oxaliplatin, Irinotecan, 5-FU, Chemotherapy, Resection, Liver resection, Neoadjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Nov 2004
- Primary completion
- Mar 2008 (actual)
- First posted
- 12 Sep 2005 (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.
General Objectives:
- To test the feasibility of neoadjuvant treatment with cetuximab/chemotherapy followed by liver resection
- To determine the optimal combination (cetuximab/FOLFOX versus cetuximab/FOLFIRI) for further trials in preoperative chemotherapy
Detailed description
Patients with liver metastasis will be screened for this study. Eligible patients will complete the pretreatment evaluation including an abdominal CT scan that will be presented to the local surgeon and the radiologist for proving of resectability of hepatic lesions. Additionally, CT scans will be reviewed by three reference surgeons. In case of non-resectability, as defined above, CT- or ultrasound- guided biopsy of one of the liver metastases will be performed, unless biopsy material is available from prior biopsy of one of the liver metastases.
Instead of an ultrasound-guided biopsy, a CT-guided biopsy may be performed.
Formalin-fixed, paraffin embedded metastatic tissue will be sent to reference laboratory (Prof. Störkel, Wuppertal) for immunohistochemical analysis of EGFR- expression.
Additionally tissue will be stored in "RNA later" for gene expression analysis if agreed by the patient.
Additionally, the primary tumor will be collected and sent to the reference laboratory for analysis of EGFR- expression (if agreement of the patient exists).
Patients will be randomized to a combination of:
Cetuximab/FOLFIRI (irinotecan/5-FU/FA) or Cetuximab/FOLFOX6 (oxaliplatin/5-FU/FA)
All patients receive a four month treatment (eight cycles) of the allocated treatment.
Resection is planned after completion of neoadjuvant treatment and should be performed between 4 and 6 weeks after the last dose of chemotherapy. Probes of the resected material (in liquid nitrogen and paraffin embedded material will be collected).
If a resection is not possible after eight administrations of chemotherapy, chemotherapy will be continued until tumor progression (maximal duration of treatment 2 years) and the patient will be evaluated for a potential resection every two months.
After resection, postoperative treatment is planned for 3 months (6 cycles). Treatment start is planned between 4 and 8 weeks after the operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Cetuximab, Procedure: Liver resection, Drug: Cetuximab and FOLFIRICetuximab and FOLFIRI |
| 2 | Active comparator | Drug: Cetuximab, Procedure: Liver resection, Drug: Cetuximab and FOLFOXCetuximab and FOLFOX |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with non-resectable, histologically confirmed, synchronous or metachronous colorectal liver metastases. Patients with non-resectable metastases are defined as; patients with five or more liver metastases; and/or patients with liver metastases that are technically non-resectable (local surgeon in cooperation with local radiologist will define non-resectability on the basis of remaining functional liver tissue, infiltration of all liver veins, infiltration of both liver arteries, both portal branches or both bile ducts).
- Patients with simultaneous liver metastases are eligible, if the primary tumor has been resected at least 1 month prior to chemotherapy.
- Karnofsky Performance Status ≥ 80
- Informed consent
- Adequate bone marrow function, liver and renal function (neutrophils > 1.5 x 10^9/l; thrombocytes > 100 x 10^9/l; hemoglobin > 8.0 g/l; bilirubin ≤ 1.5 x upper limit of normal [ULN] and not increasing more than 25% within the last 4 weeks; ALAT and ASAT < 5 x UNL; serum creatinine ≤ 1.5 x UNL)
Key exclusion criteria (13 listed)
- Any evidence of extrahepatic metastases, lymph node metastases and primary tumor recurrence
- Prior chemotherapy (except adjuvant chemotherapy with an interval of ≥ 6 months)
- Previous exposure to EGFR (epidermal growth factor receptor)-targeting therapy
- Radiotherapy or major abdominal or thoracic surgery (excluding diagnostic biopsy or port implantation) ≤ 4 weeks before study entry
- Concurrent systemic immune therapy, chemotherapy, or hormone therapy
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 | Drug | 1, 2 |
| Liver resection | Procedure or surgery | 1, 2 |
| Cetuximab and FOLFIRIAlso: Cetuximab(C225, Erbitux®, Merck KGaA), Irinotecan (irinotecan HCl, CPT-11 or Campto®, Aventis), 5-Fluorouracil (5-FU), Folinic acid (FA, i.e. Leucovorin®, Wyeth)Cetuximab 400 mg/m² (2.0 h i.v.) (first dose only), followed by: Cetuximab 250 mg/m² (1.0 h i.v.) weekly Irinotecan 180 mg/m² (2.0 h i.v.) all compounds day 1, repeated at day 15 Folinic acid (D,L) 400 mg/m² (2.0 h i.v.) 5-FU 400 mg/m² (bolus i.v.) 5-FU 2400 (-3000) mg/m² (46 h i.v.) | Drug | 1 |
| Cetuximab and FOLFOXAlso: Cetuximab(C225, Erbitux®, Merck KGaA), Oxaliplatin (L-OHP, Eloxatin®, Sanofi-Synthelabo), 5-Fluorouracil (5-FU), Folinic acid (FA, i.e. Leucovorin®, Wyeth)Cetuximab 400 mg/m² (2.0 h i.v.) (first dose only), followed by: Cetuximab 250 mg/m² (1.0 h i.v.) weekly Oxaliplatin 100 mg/m² (2.0 h i.v.) all compounds day 1, repeated at day 15 Folinic acid (D,L) 400 mg/m² (2.0 h i.v.) 5-FU 400 mg/m² (bolus i.v.) 5-FU 2400 (-3000) mg/m² (46 h i.v.) | Drug | 2 |
Primary outcome
Tumor response, defined as partial and complete response according to RECIST (Response Evaluation Criteria in Solid Tumors) - criteria in the intention-to-treat [ITT-] population
6 secondary outcomes
Rate of R0 liver resection (ITT- population)
Progression free survival (ITT- population)
Disease free survival after resection (ITT- population)
Overall survival (ITT- population)
Safety (all patients that received any study drug)
Molecular predictive markers for response and toxicity
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 27 Feb 2009.
- Derived from this study: PubMed 24585720Folprecht G, Gruenberger T, Bechstein W, Raab HR, Weitz J, Lordick F, Hartmann JT, Stoehlmacher-Williams J, Lang H, Trarbach T, Liersch T, Ockert D, Jaeger D, Steger U, Suedhoff T, Rentsch A, Kohne CH. Survival of patients with initially unresectable colorectal liver metastases treated with FOLFOX/cetuximab or FOLFIRI/cetuximab in a multidisciplinary concept (CELIM study). Ann Oncol. 2014 May;25(5):1018-25. doi: 10.1093/annonc/mdu088. Epub 2014 Feb 27.
- Derived from this study: PubMed 19942479Folprecht G, Gruenberger T, Bechstein WO, Raab HR, Lordick F, Hartmann JT, Lang H, Frilling A, Stoehlmacher J, Weitz J, Konopke R, Stroszczynski C, Liersch T, Ockert D, Herrmann T, Goekkurt E, Parisi F, Kohne CH. Tumour response and secondary resectability of colorectal liver metastases following neoadjuvant chemotherapy with cetuximab: the CELIM randomised phase 2 trial. Lancet Oncol. 2010 Jan;11(1):38-47. doi: 10.1016/S1470-2045(09)70330-4. Epub 2009 Nov 26.
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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.
Claus-Henning Köhne, Prof. Dr. principal investigator
Klinikum Oldenburg GmbH, Dr.-Eden-Str.10; 26133 Oldenburg
Gunnar Folprecht, Dr. principal investigator
University Hospital Dresden, Fetscherstr. 74, 01307 Dresden, Germany
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cetuximab, Liver resection and Cetuximab and FOLFIRI in people with Colorectal Cancer and Liver Metastases, run by Technische Universität Dresden at 21 sites in 2 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 6 inclusion and 13 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 27 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Germany, Austria. 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?
Tumor response, defined as partial and complete response according to RECIST (Response Evaluation Criteria in Solid Tumors) - criteria in the intention-to-treat [ITT-] population. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00153998, which also lists 2 linked publications.
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 27 Feb 2009.