Colorectal CancerPhase 4NCT00327093
Elaboration of a Model for Predicting Efficacy of Monoclonal Antibodies (Cetuximab and Bevacizumab) in Patients With Colorectal Cancer and Liver Metastases
A Phase 4 study testing cetuximab and bevacizumab in people with Colorectal Cancer and Neoplasm Metastasis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Primary Objective: This trial is elaborating a model for rapidly predicting (day 21) the response to monoclonal antibodies anti-EGFR and anti-VEGF (cetuximab and bevacizumab) based on biological markers and/or functional imaging. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer, Neoplasm Metastasis
- What is being tested?
- cetuximab and bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- May 2006to Oct 2008
- Phase
- Phase 4
- 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
- Patients >= 18 years old
- Patients with colon or rectal carcinoma histologically proven
- Patients with metastases (synchronous or metachronous)
- Patients with associated extra-hepatic disease (asymptomatic primary tumor or extra-hepatic metastases)
- Performance status (World Health Organization [WHO]) = 0, 1, or 2
- Life expectancy >= 3 months
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- Patients with normal haematological, kidney, and liver parameters (PNN > 1.5 x 10^9/L, platelets > 100 10^9/L, total bilirubin <= 1.25 x upper limit of normal (ULN), ASAT/ALAT <= 5 x ULN, creatinaemia <= 135 µmol/L (1.5 mg/dL)
- No cardiac or coronary insufficiency untreated
- At least 4 weeks between surgery and study beginning
- Patients can have a biopsy of the hepatic lesion identified by ultrasound.
- Informed consent signed.
Who cannot join
- Patients with symptomatic tumors (colon or rectal)
- Patients with others tumors not cured
- Patients who cannot be treated by 5-fluorouracil (5-FU) and/or irinotecan because of special medical conditions or other serious disease.
- Patients who participated in another clinical trial since less than 30 days
- Pregnancy or breast-feeding women
- Patients who cannot be treated because of active infection or other serious disease.
Trial locations and contacts
1 site in 1 country.
About this study
Primary Objective: This trial is elaborating a model for rapidly predicting (day 21) the response to monoclonal antibodies anti-EGFR and anti-VEGF (cetuximab and bevacizumab) based on biological markers and/or functional imaging. The response to treatment is evaluated by the conventional method after 2 months (Response Evaluation Criteria in Solid Tumors [RECIST] criteria).
Secondary Objectives:
Read more
- This trial is also analyzing the correlation between the magnitude of response to treatment at 2 months (stabilization or objective response, RECIST criteria) and that of response observed after 6 months of treatment.
- The organisational objective is to develop a tumour bank of metastatic colorectal cancer.
Population: The population includes 252 male and female patients with metastatic colorectal cancer justifying the use of cetuximab or bevacizumab, with no heart disease.
Techniques: Computed tomography (CT scan), functional imaging (ultrasound with SonoVue); molecular imaging (positron emission tomography [PET] with fluorodeoxyglucose F18 [18-FDG]); and biology and pathology on microbiopsy of liver metastasis are used.
Outcome Criteria: The primary outcome is response to treatment with monoclonal antibodies according to RECIST criteria at two months.
Studied Factors:
Radiology:
- CT scan: RECIST criteria (gold standard);
- Ultrasound with SonoVue injection: 1 representative target (delay of contrast appearance, peak of rising, curve of increase and decrease of the signal, area under the curve, time of average transit).
Nuclear Medicine: PET scan and 18-FDG (standard uptake values [SUV])
Molecular Characterization of Tumors: p53 status; microsatellite instability (MSI) status; expression of oncogenes; EGFR status; VEGF status; determination of FcgammaRIIIA polymorphisms
Statistics:
- Descriptive analyses;
- Analysis of the appropriate threshold to measure: response to treatment by an ultrasound with SonoVue and by PET scan; correlation between response predicted by the ultrasound with SonoVue and the PET; conventional morphological CT at 2 months
- Analysis of prognostic factors:
- Evaluation of the role of each prognostic factor (pathology and imaging) on response to treatment;
- Multivariate analysis of prognostic factors;
- Analysis of the prognostic power of early response at 2 months on the response observed after 6 months of treatment.
- Conditions
- Colorectal Cancer, Neoplasm Metastasis
- Being tested
- cetuximab, bevacizumab
- Keywords
- Colorectal cancer,, immunohistochemistry,, monoclonal antibodies,, predictive model,, antiangiogenic agents,, medical imaging, Colorectal cancer with liver metastases
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cetuximabDrug
Also called Erbitux
indication : second intention treatment
bevacizumabDrug
Also called Avastin
Indication: first intention treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Bevacizumab Receives: Drug: bevacizumab |
| 2 | Experimental | Cetuximab Receives: Drug: cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elaboration of a predictive model, based on biological and functional imaging parameters, for the response to monoclonal antibodies as assessed through RECIST criteria 2 months after the beginning of treatment
Measured: at 7 weeks
Secondary outcomes (1)
Correlation between the response at 2 months and that at 6 months of treatment (taking into account the therapeutic adjustments during the 6-month follow-up)
Measured: at 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2006 (estimated)
- Study startMay 2006
- Primary completionOct 2008
- Study completionOct 2008
Why it stopped: The scientific commitee decided to stop the inclusions and exploit the results.
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.
- More trials run by Hospices Civils de LyonThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Investigators
- Jean-Alain Chayvialle, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00327093
- Sponsor's protocol ID
- 2005-401
- Status last verified
- Feb 2009
- First submitted
- 17 May 2006
- Last updated
- 9 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elaboration of a Model for Predicting Efficacy of Monoclonal Antibodies (Cetuximab and Bevacizumab) in Patients With Colorectal Cancer and Liver Metastases
- ClinicalTrials.gov ID
- NCT00327093
- Acronym / sponsor ID
- 2005-401
- Conditions
- Colorectal Cancer, Neoplasm Metastasis
- Keywords
- Colorectal cancer,, immunohistochemistry,, monoclonal antibodies,, predictive model,, antiangiogenic agents,, medical imaging, Colorectal cancer with liver metastases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The scientific commitee decided to stop the inclusions and exploit the results.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 18 May 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.
Primary Objective: This trial is elaborating a model for rapidly predicting (day 21) the response to monoclonal antibodies anti-EGFR and anti-VEGF (cetuximab and bevacizumab) based on biological markers and/or functional imaging. The response to treatment is evaluated by the conventional method after 2 months (Response Evaluation Criteria in Solid Tumors [RECIST] criteria).
Secondary Objectives:
- This trial is also analyzing the correlation between the magnitude of response to treatment at 2 months (stabilization or objective response, RECIST criteria) and that of response observed after 6 months of treatment.
- The organisational objective is to develop a tumour bank of metastatic colorectal cancer.
Population: The population includes 252 male and female patients with metastatic colorectal cancer justifying the use of cetuximab or bevacizumab, with no heart disease.
Techniques: Computed tomography (CT scan), functional imaging (ultrasound with SonoVue); molecular imaging (positron emission tomography [PET] with fluorodeoxyglucose F18 [18-FDG]); and biology and pathology on microbiopsy of liver metastasis are used.
Outcome Criteria: The primary outcome is response to treatment with monoclonal antibodies according to RECIST criteria at two months.
Studied Factors:
Radiology:
- CT scan: RECIST criteria (gold standard);
- Ultrasound with SonoVue injection: 1 representative target (delay of contrast appearance, peak of rising, curve of increase and decrease of the signal, area under the curve, time of average transit).
Nuclear Medicine: PET scan and 18-FDG (standard uptake values [SUV])
Molecular Characterization of Tumors: p53 status; microsatellite instability (MSI) status; expression of oncogenes; EGFR status; VEGF status; determination of FcgammaRIIIA polymorphisms
Statistics:
- Descriptive analyses;
- Analysis of the appropriate threshold to measure: response to treatment by an ultrasound with SonoVue and by PET scan; correlation between response predicted by the ultrasound with SonoVue and the PET; conventional morphological CT at 2 months
- Analysis of prognostic factors:
- Evaluation of the role of each prognostic factor (pathology and imaging) on response to treatment;
- Multivariate analysis of prognostic factors;
- Analysis of the prognostic power of early response at 2 months on the response observed after 6 months of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: bevacizumabBevacizumab |
| 2 | Experimental | Drug: cetuximabCetuximab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients >= 18 years old
- Patients with colon or rectal carcinoma histologically proven
- Patients with metastases (synchronous or metachronous)
- Patients with associated extra-hepatic disease (asymptomatic primary tumor or extra-hepatic metastases)
- Performance status (World Health Organization [WHO]) = 0, 1, or 2
Key exclusion criteria (6 listed)
- Patients with symptomatic tumors (colon or rectal)
- Patients with others tumors not cured
- Patients who cannot be treated by 5-fluorouracil (5-FU) and/or irinotecan because of special medical conditions or other serious disease.
- Patients who participated in another clinical trial since less than 30 days
- Pregnancy or breast-feeding women
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 |
|---|---|---|
| cetuximabAlso: Erbituxindication : second intention treatment | Drug | 2 |
| bevacizumabAlso: AvastinIndication: first intention treatment | Drug | 1 |
Primary outcome
Elaboration of a predictive model, based on biological and functional imaging parameters, for the response to monoclonal antibodies as assessed through RECIST criteria 2 months after the beginning of treatment
Time frame: at 7 weeks
1 secondary outcome
Correlation between the response at 2 months and that at 6 months of treatment (taking into account the therapeutic adjustments during the 6-month follow-up)
Time frame: at 6 month
Results and safety
The study was stopped early (reason given: The scientific commitee decided to stop the inclusions and exploit the results.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2009.
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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.
Jean-Alain Chayvialle, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cetuximab and bevacizumab in people with Colorectal Cancer and Neoplasm Metastasis, run by Hospices Civils de Lyon at 1 site in France.
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 11 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: stopped early, as of the sponsor's last update on 9 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 1 site in France. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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: The scientific commitee decided to stop the inclusions and exploit the results.). 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?
Elaboration of a predictive model, based on biological and functional imaging parameters, for the response to monoclonal antibodies as assessed through RECIST criteria 2 months after the beginning of treatment (time frame: at 7 weeks). 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 9 Feb 2009.