Colorectal Cancer MetastaticPhase 2BOS2NCT01508000
Efficacy of FOLFOX Alone, FOLFOX Plus Bevacizumab and FOLFOX Plus Panitumumab in Patients With Resectable Liver Metastases
A Phase 2 study testing FOLFOX6, Bevacizumab and Panitumumab in people with Colorectal Cancer Metastatic and Liver Metastases, run by European Organisation for Research and Treatment of Cancer - EORTC at 25 sites in 6 countries.
Trial summary
Patients presenting with multiple innumerable liver metastases will probably never come to resection, however, for all others, including patients with numerous multiple metastases or large metastases,resection should be considered after limited chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer Metastatic, Liver Metastases, KRAS Wild Type Colorectal Cancer
- What is being tested?
- FOLFOX6, Bevacizumab and Panitumumab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 25 sitesin 6 countries
- Study dates
- Jun 2013to Sep 2016
- 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
- Histologically proven CRC with 1 to 8 metachronous or synchronous liver metastases considered to be completely resectable.
- Primary tumor (or liver metastasis) of CRC must be KRAS and NRAS status "wild type".
- Patients must have undergone complete resection (R0) of the primary tumor at least 4 weeks before randomization. Or for patients with synchronous metastases the primary tumor can be resected (R0) at the same time as the liver metastases if: the patient has a non-obstructive primary tumor and is able to receive preoperative chemotherapy (3-4 months) before surgery.
- Measurable hepatic disease by RECIST version 1.1.
- Patients must be 18 years old or older.
- A WHO performance status of 0 or 1. Radiotherapy alone is allowed if given pre or post protocol treatment.
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- Previous adjuvant chemotherapy for primary CRC is allowed if completed at least 12 months before inclusion in this study.
- All the following tests should be done within 4 weeks prior to randomization:
- Absolute neutrophil count ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, hemoglobin ≥ 9 g/dL and white blood cell count (WBC) ≥ 3 x 109/L.
- Serum creatinine ≤ 1.5 times the upper limit of normal (ULN) (to exclude severe renal impairment); no significant proteinuria (urine protein < 1g/24 hours urine collection) OR urine protein/creatinine ratio < 1.0 OR 1+ proteinuria on urine dipstick.
- Absence of major hepatic insufficiency (bilirubin ≤ 1.5 x ULN and aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) ≤ 5 x ULN).
- Magnesium ≥ lower limit of normal (LLN)
- Patients with a buffer range from the normal values of +/- 5% for hematology and +/- 10% for biochemistry are acceptable. This will not apply for Renal Function, including Creatinine.
- Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 14 days prior to the first dose of study treatment.
- Patients of childbearing / reproductive potential should use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 6 months after the last study treatment. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.
- Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 6 months after the last study treatment.
- Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
Who cannot join
- Evidence of extra-hepatic metastasis (of CRC).
- Previous chemotherapy for metastatic disease or surgical treatment (e.g. surgical resection or radiofrequency ablation) for liver metastasis.
- Previous exposure to EGFR or VEGF/VEGFR targeting therapy within the last 12 months.
- Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks prior to randomization.
- Regular use of aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs).
- Bleeding diathesis (e.g. hemoptysis of ≥ 1/2 teaspoon or 2.5mL), coagulopathy, or need for administration of full-dose anti-coagulant(s).
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- Clinically significant cardiovascular disease, including: uncontrolled hypertension, New York Heart Association (NYHA) class II-IV heart failure, myocardial infarction or unstable angina pectoris, cerebrovascular accident or transient ischemic attack within the past 12 months, peripheral vascular disease ≥ grade 2, serious cardiac arrhythmia requiring medication and other clinically significant cardiovascular disease.
- Peripheral neuropathy > grade 1 (Common Terminology Criteria for Adverse Events, v4.0) serious wound complications, ulcers, or bone fractures.
- Symptomatic diverticulitis or active or uncontrolled gastroduodenal ulceration.
- History or evidence of interstitial lung disease (e.g. pneumonitis, pulmonary fibrosis)
- Significant disease that, in the investigator's opinion, would exclude the patient from the study. Including known allergy or any other adverse reaction to any of the study drugs (including any of the excipients) or to any related compound, including hypersensitivity to Chinese hamster ovary (CHO) cell products or other recombinant human or humanized antibodies.
- Presence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
- Participation in another clinical study (except sub studies of this protocol) within the 30 days before randomization and during this study.
Trial locations and contacts
25 sites in 6 countries.
25 sites in 6 countries
France16 sites
Institut Sainte Catherine
Avignon
Institut Bergonie
Bordeaux
CHU Ambroise Pare
Boulogne-Billancourt, F-92104
Assistance Publique - Hôpitaux de Paris - Hopital De Bicetre AP-HP
Le Kremlin-Bicêtre
Centre Hospitalier Saint Joseph Saint Luc
Lyon
Centre Leon Berard
Lyon
Hopital Prive Jean Mermoz
Lyon
Centre Antoine Lacassagne
Nice
Hopital Europeen Georges Pompidou
Paris, 75015
Groupe Hospitalier Diaconesses Croix Saint-Simon - Site Reuilly
Paris
CHU de Lyon - Centre Hospitalier Lyon Sud
Pierre-Benite (lyon)
CHU de Reims - Hôpital Robert Debré
Reims
Hopital Charles Nicolle
Rouen
Centre Hospitalier Privé Saint-Grégoire
Saint-Grégoire
CHU Saint-Etienne - CHU de Saint-Etienne - Hopital Nord
Saint-Priest-en-Jarez
CHU d'Amiens - CHU Amiens - Hopital Sud
Salouël
Belgium5 sites
Hopital Universitaire Brugmann
Brussels
Universitair Ziekenhuis Gent
Ghent
AZ Groeninge Kortrijk - Campus Kennedylaan
Kortrijk
AZ Turnhout - Campus Sint Elisabeth
Turnhout
Centre Hospitalier Peltzer-La Tourelle
Verviers
Netherlands1 site
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
Amsterdam
Switzerland1 site
Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie
Geneva
About this study
Official title: Randomized Phase II Trial Evaluating the Efficacy of FOLFOX Alone, FOLFOX Plus Bevacizumab and FOLFOX Plus Panitumumab as Perioperative Treatment in Patients With Resectable Liver Metastases From Wild Type KRAS/NRAS Colorectal Cancer
Patients presenting with multiple innumerable liver metastases will probably never come to resection, however, for all others, including patients with numerous multiple metastases or large metastases,resection should be considered after limited chemotherapy.
There is consensus for a backbone chemotherapy consisting of fluoropyrimidine + oxaliplatin. FOLFOX was used in the previous EORTC study and is again recommended.
Read more
The addition of targeted agents to standard chemotherapy in the perioperative strategy for mCRC might increase the ORR and R0 resectability, without significant increase in toxicity, therefore translating to a better outcome.
It was therefore decided to design an open label, randomized, multi-center, 3-arm late phase II study.
Arm A: (standard) mFOLFOX6 + Surgery Arm B: (experimental) mFOLFOX6 + Bevacizumab + Surgery Arm C: (experimental) mFOLFOX6 + Panitumumab + Surgery
- Being tested
- FOLFOX6, Bevacizumab, Panitumumab, Surgery
- Keywords
- Liver metastases, Colorectal Cancer, KRAS wild type, FOLFOX, Bevacizumab, Panitumumab, Randomized, Phase II, Perioperative treatment, Adjuvant, Neo-adjuvant, Surgery, Progression Free Survival
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFOX6Drug
Also called Chemotherapy
5-FU, folinic acid, oxaliplatin
BevacizumabBiological
Also called Avastin
Targeted therapy
PanitumumabBiological
Also called Vectibix
Targeted therapy
SurgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm A: modified FOLFOX6 and Surgery | Active comparator | 6 cycles before and 6 cycles after surgery consisting in:
Hour 0: Oxaliplatin 85 mg/m² IV 2-h infusion
Hour 0: Folinic Acid 400 mg/m² (DL form) or 200 mg/m2 (L form) IV 2-h infusion
Hour 2: 5-FU 400 mg/m² IV bolus over 2-4 minutes
Hour 2: 5-FU 2400 mg/m² given as a continuous infusion over 46h.
On day 1 of a 14 day cycle Receives: Drug: FOLFOX6; Procedure: Surgery |
| Arm B: modified FOLFOX6 + Bevacizumab and Surgery | Experimental | 6 cycles before and 6 cycles after surgery consisting in:
Hour 0: Oxaliplatin 85 mg/m2 2-h infusion
Hour 0: Folinic Acid 400 mg/m2 (DL form) or 200 mg/m2 (L form) 2-h infusion
Hour 2 (before 5-FU bolus): Bevacizumab 5 mg/kg IV over 90 minutes infusion*.
Hour 3.5: 5-FU bolus 400 mg/m2 IV bolus over 2-4 minutes
Hour 3.5: 5-FU 2400 mg/m² given as a continuous infusion over 46h.
On day 1 of a 14 day cycle Receives: Drug: FOLFOX6; Biological: Bevacizumab; Procedure: Surgery |
| Arm C: modified FOLFOX6 + Panitumumab and Surgery | Experimental | Experimental: Arm B: modified FOLFOX6 + Bevacizumab and Surgery
6 cycles before and 6 cycles after surgery consisting in:
Hour - 1 (pre chemotherapy): Panitumumab 6 mg/kg IV over 60 minutes (≤ 1000 mg) or 90 minutes (> 1000 mg) +/- 15 min. infusion*.
Hour 0: Oxaliplatin 85 mg/m² IV 2-h infusion
Hour 0: Folinic Acid 400 mg/m² (DL form) or 200 mg/m2 (L form) IV 2-h infusion
Hour 2: 5-FU 400 mg/m² IV bolus over 2-4 minutes
Hour 2: 5-FU 2400 mg/m² given as a continuous infusion over 46h.
On day 1 of a 14 day cycle Receives: Drug: FOLFOX6; Biological: Panitumumab; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Increase in progression free survival rate at 1 year in each experimental arm (mFOLFOX6 + bevacizumab or panitumumab) compared to mFOLFOX6 alone arm.
Measured: 1 year
Secondary outcomes (4)
Pathological response rate
Increase in major pathological response rate between mFOLFOX6 alone arm and each experimental arm.
Measured: 4 years
Resection rate
Compare the percentage of patients with total resection with these three treatments.
Measured: 4 years
Overall survival
Overall survival is defined as the time interval between the date of randomization and the date of death. Patients who are still alive when last traced will be censored at the date of last follow-up.
Measured: 8 years
Safety
All adverse events will be recorded; the investigator will assess whether those events are drug related (reasonable possibility, no reasonable possibility) and this assessment will be recorded in the database for all adverse events.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2012 (estimated)
- Study startJun 2013
- Primary completionSep 2016
- Study completionSep 2016
Why it stopped: Low or poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe 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
- 44 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Collaborators
- Amgen, Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Bernard Nordlinger, Pr., Study chair, C.H.U. AMBROISE PARE AP-HP, Boulogne-Billancourt, FranceStephane Benoist, Pr., Study chair, HOPITAL DE BICETRE AP-HP, Le Kremlin Bicetre, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01508000
- Sponsor's protocol ID
- EORTC-40091
- Other IDs
- 2010-019238-29
- Acronym
- BOS2
- Status last verified
- Oct 2016
- First submitted
- 9 Jan 2012
- Last updated
- 12 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial Evaluating the Efficacy of FOLFOX Alone, FOLFOX Plus Bevacizumab and FOLFOX Plus Panitumumab as Perioperative Treatment in Patients With Resectable Liver Metastases From Wild Type KRAS/NRAS Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01508000
- Acronym / sponsor ID
- BOS2 / EORTC-40091
- Keywords
- Liver metastases, Colorectal Cancer, KRAS wild type, FOLFOX, Bevacizumab, Panitumumab, Randomized, Phase II
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low or poor accrual
- Enrolment
- 44 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Collaborators
- Amgen, Roche Pharma AG
- Study start
- Jun 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 11 Jan 2012 (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.
Patients presenting with multiple innumerable liver metastases will probably never come to resection, however, for all others, including patients with numerous multiple metastases or large metastases,resection should be considered after limited chemotherapy.
There is consensus for a backbone chemotherapy consisting of fluoropyrimidine + oxaliplatin. FOLFOX was used in the previous EORTC study and is again recommended.
The addition of targeted agents to standard chemotherapy in the perioperative strategy for mCRC might increase the ORR and R0 resectability, without significant increase in toxicity, therefore translating to a better outcome.
It was therefore decided to design an open label, randomized, multi-center, 3-arm late phase II study.
Arm A: (standard) mFOLFOX6 + Surgery Arm B: (experimental) mFOLFOX6 + Bevacizumab + Surgery Arm C: (experimental) mFOLFOX6 + Panitumumab + Surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: modified FOLFOX6 and Surgery | Active comparator | Drug: FOLFOX6, Procedure: Surgery6 cycles before and 6 cycles after surgery consisting in: Hour 0: Oxaliplatin 85 mg/m² IV 2-h infusion Hour 0: Folinic Acid 400 mg/m² (DL form) or 200 mg/m2 (L form) IV 2-h infusion Hour 2: 5-FU 400 mg/m² IV bolus over 2-4 minutes Hour 2: 5-FU 2400 mg/m² given as a continuous infusion over 46h. On day 1 of a 14 day cycle |
| Arm B: modified FOLFOX6 + Bevacizumab and Surgery | Experimental | Drug: FOLFOX6, Biological: Bevacizumab, Procedure: Surgery6 cycles before and 6 cycles after surgery consisting in: Hour 0: Oxaliplatin 85 mg/m2 2-h infusion Hour 0: Folinic Acid 400 mg/m2 (DL form) or 200 mg/m2 (L form) 2-h infusion Hour 2 (before 5-FU bolus): Bevacizumab 5 mg/kg IV over 90 minutes infusion*. Hour 3.5: 5-FU bolus 400 mg/m2 IV bolus over 2-4 minutes Hour 3.5: 5-FU 2400 mg/m² given as a continuous infusion over 46h. On day 1 of a 14 day cycle |
| Arm C: modified FOLFOX6 + Panitumumab and Surgery | Experimental | Drug: FOLFOX6, Biological: Panitumumab, Procedure: SurgeryExperimental: Arm B: modified FOLFOX6 + Bevacizumab and Surgery 6 cycles before and 6 cycles after surgery consisting in: Hour - 1 (pre chemotherapy): Panitumumab 6 mg/kg IV over 60 minutes (≤ 1000 mg) or 90 minutes (> 1000 mg) +/- 15 min. infusion*. Hour 0: Oxaliplatin 85 mg/m² IV 2-h infusion Hour 0: Folinic Acid 400 mg/m² (DL form) or 200 mg/m2 (L form) IV 2-h infusion Hour 2: 5-FU 400 mg/m² IV bolus over 2-4 minutes Hour 2: 5-FU 2400 mg/m² given as a continuous infusion over 46h. On day 1 of a 14 day cycle |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histologically proven CRC with 1 to 8 metachronous or synchronous liver metastases considered to be completely resectable.
- Primary tumor (or liver metastasis) of CRC must be KRAS and NRAS status "wild type".
- Patients must have undergone complete resection (R0) of the primary tumor at least 4 weeks before randomization. Or for patients with synchronous metastases the primary tumor can be resected (R0) at the same time as the liver metastases if: the patient has a non-obstructive primary tumor and is able to receive preoperative chemotherapy (3-4 months) before surgery.
- Measurable hepatic disease by RECIST version 1.1.
- Patients must be 18 years old or older.
Key exclusion criteria (13 listed)
- Evidence of extra-hepatic metastasis (of CRC).
- Previous chemotherapy for metastatic disease or surgical treatment (e.g. surgical resection or radiofrequency ablation) for liver metastasis.
- Previous exposure to EGFR or VEGF/VEGFR targeting therapy within the last 12 months.
- Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks prior to randomization.
- Regular use of aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs).
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 |
|---|---|---|
| FOLFOX6Also: Chemotherapy5-FU, folinic acid, oxaliplatin | Drug | Arm A: modified FOLFOX6 and Surgery, Arm B: modified FOLFOX6 + Bevacizumab and Surgery, Arm C: modified FOLFOX6 + Panitumumab and Surgery |
| BevacizumabAlso: AvastinTargeted therapy | Biological | Arm B: modified FOLFOX6 + Bevacizumab and Surgery |
| PanitumumabAlso: VectibixTargeted therapy | Biological | Arm C: modified FOLFOX6 + Panitumumab and Surgery |
| Surgery | Procedure or surgery | Arm A: modified FOLFOX6 and Surgery, Arm B: modified FOLFOX6 + Bevacizumab and Surgery, Arm C: modified FOLFOX6 + Panitumumab and Surgery |
Primary outcome
Progression free survival
Time frame: 1 year
Increase in progression free survival rate at 1 year in each experimental arm (mFOLFOX6 + bevacizumab or panitumumab) compared to mFOLFOX6 alone arm.
4 secondary outcomes
Pathological response rate
Time frame: 4 years
Resection rate
Time frame: 4 years
Overall survival
Time frame: 8 years
Safety
Time frame: 4 years
Results and safety
The study was stopped early (reason given: Low or poor accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 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.
Bernard Nordlinger, Pr. study chair
C.H.U. AMBROISE PARE AP-HP, Boulogne-Billancourt, France
Stephane Benoist, Pr. study chair
HOPITAL DE BICETRE AP-HP, Le Kremlin Bicetre, France
25 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FOLFOX6, Bevacizumab and Panitumumab in people with Colorectal Cancer Metastatic and Liver Metastases, run by European Organisation for Research and Treatment of Cancer - EORTC at 25 sites in 6 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 17 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: stopped early, as of the sponsor's last update on 12 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in France, Belgium, Austria, Netherlands, Spain and 1 more country. 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 was stopped early (reason given: Low or poor accrual). Results are not available in the source record.
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?
Progression free survival (time frame: 1 year). 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 12 Oct 2016.