Colorectal CancerPhase 2NCT00544349
Leucovorin, Fluorouracil, Cetuximab, and Oxaliplatin in Treating Patients With Stage IV Colorectal Cancer and Liver Metastases That Cannot Be Removed by Surgery
A Phase 2 study testing cetuximab, fluorouracil and leucovorin calcium in people with Colorectal Cancer and Metastatic Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 7 sites in France.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer, Metastatic Cancer
- What is being tested?
- cetuximab, fluorouracil and leucovorin calcium
- How many people
- 45 participants
- Where
- 7 sitesFrance
- Study dates
- Oct 2006to May 2011
- 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
- WHO performance status 0-1
- Life expectancy > 3 months
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9 g/dL
- Creatinine ≤ 1.5 times normal
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- Bilirubin ≤ 1.5 times upper limit of normal
- Transaminases ≤ 5 times normal
- Not pregnant or nursing
- Fertile patients must use effective contraception
Who cannot join
- Contraindication or allergy grade 3-4 to any components of the study drugs
- Peripheral neuropathy
- Intestinal occlusion or subocclusion or prior inflammatory intestinal disease
- Severe cardiac disease including any of the following:
- Symptomatic coronary disease
- Myocardial infarction in the past 6 months
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- New York Heart Association grade II-IV cardiac insufficiency
- Severe arrhythmia (even if treated)
- Active or uncontrolled infection
- Other concurrent serious disorder
- Severe uncontrolled medical condition
- Other malignancy within the past 5 years or concurrently except basal cell skin cancer or carcinoma in situ of the cervix
- Study impossible due to psychological, geographical, or social reasons
- Prisoners or patients under guardianship
- PRIOR CONCURRENT THERAPY:
- Prior chemotherapy except adjuvant chemotherapy comprising fluorouracil, leucovorin calcium, capecitabine, oxaliplatin, irinotecan hydrochloride, and/or bevacizumab (completed > 6 months ago if oxaliplatin- or irinotecan-based)
- Prior epidermal growth factor (EGF), monoclonal antibody inhibiting transduction of EGF receptor (EGFR), or any other treatment targeting the EGFR
- Other concurrent anticancer immunotherapy, chemotherapy, or hormone therapy
- Participation in another study in the past 30 days
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Hopital Saint Andre
Bordeaux, 33075
Centre Regional Francois Baclesse
Caen, 14076
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, 21079
CHU Pitie-Salpetriere
Paris, 75651
Centre Eugene Marquis
Rennes, 35062
Hopital Paul Brousse
Villejuif, 94804
Institut Gustave Roussy
Villejuif, F-94805
About this study
Official title: Phase II Study Evaluating the Effectiveness of the Association of Chemotherapy LV5FU2 Simplified and Cetuximab With Intra-arterial Hepatic Chemotherapy Using Oxaliplatin in Patients With Colorectal Cancer and Nonresectable Hepatic Metastases
RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving more than one drug (combination chemotherapy) and giving them together with cetuximab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving leucovorin together with fluorouracil, cetuximab, and oxaliplatin works in treating patients with stage IV colorectal cancer and liver metastases that cannot be removed by surgery.
Read the detailed description
OBJECTIVES:
Primary
- Determine the efficacy of this regimen by the measurement of objective response rate (RECIST criteria).
Secondary
- Determine the toxicity of this regimen.
- Evaluate the duration of tumor response.
- Determine the duration and rate of tumor control.
- Determine the rate of secondary resectability of hepatic metastases.
- Evaluate progression-free survival
- Determine rate of progression of the tumor.
- Determine overall survival.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV over 1 hour, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours. Patients also receive oxaliplatin by hepatic arterial infusion over 2 hours. Treatment continues for at least 3 months in the absence of disease progression or unacceptable toxicity.
- Conditions
- Colorectal Cancer, Metastatic Cancer
- Being tested
- cetuximab, fluorouracil, leucovorin calcium, oxaliplatin
- Keywords
- stage IV colon cancer, recurrent colon cancer, stage IV rectal cancer, recurrent rectal cancer, liver metastases
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cetuximabBiological
fluorouracilDrug
oxaliplatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: objective tumor response rate (RECIST criteria)
Secondary outcomes (7)
Toxicity as assessed by NCI CTCAE v3.0
Duration of response
Duration and rate of tumor control
Secondary resectability of hepatic metastases
Progression-free survival
Overall survival
Tumor progression rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2007 (estimated)
- Study startOct 2006
- Primary completionMay 2011
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 Gustave Roussy, Cancer Campus, Grand ParisThe 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
- Non-randomised
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Investigators
- David Malka, MD, PhD, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00544349
- Sponsor's protocol ID
- CDR0000564063
- Other IDs
- FRE-IGR-CHOICE, IGR-1207, INCA-RECF0449
- Status last verified
- Jul 2009
- First submitted
- 13 Oct 2007
- Last updated
- 17 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Evaluating the Effectiveness of the Association of Chemotherapy LV5FU2 Simplified and Cetuximab With Intra-arterial Hepatic Chemotherapy Using Oxaliplatin in Patients With Colorectal Cancer and Nonresectable Hepatic Metastases
- ClinicalTrials.gov ID
- NCT00544349
- Acronym / sponsor ID
- CDR0000564063
- Conditions
- Colorectal Cancer, Metastatic Cancer
- Keywords
- stage IV colon cancer, recurrent colon cancer, stage IV rectal cancer, recurrent rectal cancer, liver metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- May 2011 (actual)
- First posted
- 16 Oct 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.
RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving more than one drug (combination chemotherapy) and giving them together with cetuximab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving leucovorin together with fluorouracil, cetuximab, and oxaliplatin works in treating patients with stage IV colorectal cancer and liver metastases that cannot be removed by surgery.
Detailed description
OBJECTIVES:
Primary
- Determine the efficacy of this regimen by the measurement of objective response rate (RECIST criteria).
Secondary
- Determine the toxicity of this regimen.
- Evaluate the duration of tumor response.
- Determine the duration and rate of tumor control.
- Determine the rate of secondary resectability of hepatic metastases.
- Evaluate progression-free survival
- Determine rate of progression of the tumor.
- Determine overall survival.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV over 1 hour, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours. Patients also receive oxaliplatin by hepatic arterial infusion over 2 hours. Treatment continues for at least 3 months in the absence of disease progression or unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- WHO performance status 0-1
- Life expectancy > 3 months
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9 g/dL
Key exclusion criteria (19 listed)
- Contraindication or allergy grade 3-4 to any components of the study drugs
- Peripheral neuropathy
- Intestinal occlusion or subocclusion or prior inflammatory intestinal disease
- Severe cardiac disease including any of the following:
- Active or uncontrolled infection
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 | Biological | – |
| fluorouracil | Drug | – |
| leucovorin calcium | Drug | – |
| oxaliplatin | Drug | – |
Primary outcome
Efficacy: objective tumor response rate (RECIST criteria)
7 secondary outcomes
Toxicity as assessed by NCI CTCAE v3.0
Duration of response
Duration and rate of tumor control
Secondary resectability of hepatic metastases
Progression-free survival
Overall survival
Tumor progression rate
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 17 May 2011.
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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.
David Malka, MD, PhD
Gustave Roussy, Cancer Campus, Grand Paris
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cetuximab, fluorouracil and leucovorin calcium in people with Colorectal Cancer and Metastatic Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 7 sites 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 10 inclusion and 19 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 17 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 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?
Efficacy: objective tumor response rate (RECIST criteria). 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 17 May 2011.