Colorectal CancerPhase 2ERBIFORTNCT00557102
Cetuximab and Combination Chemotherapy as First-Line Therapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver and/or Lung
A Phase 2 study testing cetuximab, filgrastim and fluorouracil in people with Colorectal Cancer and Metastatic Cancer, run by National Cancer Institute, France at 1 site in France.
Trial summary
RATIONALE: 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Metastatic Cancer
- What is being tested?
- cetuximab, filgrastim and fluorouracil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2007to Dec 2010
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the colon or rectum
- Must have synchronous or metasynchronous unresectable hepatic metastases
- Less than 8 hepatic metastases
- Less than 6 segments of liver involvement with metastases
- No more than 2 potentially resectable extrahepatic (e.g., pulmonary) metastases
- Patients with visceral metastases that are potentially resectable after chemotherapy (i.e., tumor regression) are eligible
- At least 1 measurable metastasis by CT scan or MRI
- No brain metastases, bone metastases, or carcinomatous meningitis
- No celiac lymph node involvement or peritoneal cancer
PATIENT CHARACTERISTICS:
- WHO performance status 0-1
- Life expectancy > 3 months
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- PT rate > 70%
- Bilirubin < 30 μmol/L
- Creatinine < 130 μmol/L
- Creatinine clearance > 60 mL/min
- Not pregnant or nursing
- No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix
- No severe unstable angina
- No symptomatic heart failure
- No other concurrent illness
PRIOR CONCURRENT THERAPY:
- At least 3 months since prior adjuvant anticancer chemotherapy
- No concurrent participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Frontline Chemotherapy "Reinforced" for Cancers of the Colon and Rectum With Potentially Resectable Hepatic and/or Pulmonary Metastases: Association of FOLFIRI and ERBITUX
RATIONALE: 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. Drugs used in chemotherapy, such as irinotecan, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with combination chemotherapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cetuximab together with combination chemotherapy works as first-line therapy in treating patients with colorectal cancer that has spread to the liver and/or lung.
Read the detailed description
OBJECTIVES:
Primary
- Determine the tumor response rate in patients with colorectal cancer and hepatic and/or pulmonary metastases treated with cetuximab and FOLFIRI chemotherapy comprising irinotecan hydrochloride, leucovorin calcium, and fluorouracil as first-line therapy.
Secondary
- Determine the rate of resectability in patients treated with this regimen.
- Determine the overall and disease-free survival of patients treated with this regimen.
- Determine the tolerability of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV over 60-120 minutes on days 1 and 8. Patients also receive FOLFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 48 hours on days 1 and 2. Patients with 7/6 or 7/7 genotypes also receive filgrastim (G-CSF) as primary prophylaxis (patients with 6/6 genotypes receive G-CSF as secondary prophylaxis). Treatment repeats every 2 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity. Within 6 weeks after the completion of cetuximab and FOLFIRI chemotherapy, patients with responding disease undergo surgical resection of visceral metastases.
- Conditions
- Colorectal Cancer, Metastatic Cancer
- Being tested
- cetuximab, filgrastim, fluorouracil, irinotecan hydrochloride, leucovorin calcium
- Keywords
- liver metastases, lung metastases, recurrent rectal cancer, stage IV rectal cancer, adenocarcinoma of the rectum, adenocarcinoma of the colon, recurrent colon cancer, stage IV colon cancer
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis, Rectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cetuximabBiological
filgrastimBiological
fluorouracilDrug
| Study group | Role | What they receive |
|---|---|---|
| cetuximab, FOLFIRI | Other | Not described Receives: Biological: cetuximab; Biological: filgrastim; Drug: fluorouracil; Drug: irinotecan hydrochloride; Drug: leucovorin calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response rate
Measured: From baseline to end of treatment
Secondary outcomes (3)
Rate of resectability
Measured: From baseline to end of treatment
Overall and disease-free survival
Measured: From baseline to end of treatment
Tolerability
Measured: From baseline to end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2007 (estimated)
- Study startSep 2007
- Primary completionDec 2010
- Study completionDec 2010
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, France
- Sponsor type
- Other government
- Collaborators
- University Hospital, Grenoble
- Responsible party
- Sponsor
- Investigators
- Jean Marc Phelip, MD, PhD, Study chair, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00557102
- Sponsor's protocol ID
- CDR0000574153
- Other IDs
- CHUG-ERBIFORT, INCA-RECF0316, EUDRACT-2007-000357-54
- Acronym
- ERBIFORT
- Status last verified
- Dec 2012
- First submitted
- 9 Nov 2007
- Last updated
- 11 Dec 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frontline Chemotherapy "Reinforced" for Cancers of the Colon and Rectum With Potentially Resectable Hepatic and/or Pulmonary Metastases: Association of FOLFIRI and ERBITUX
- ClinicalTrials.gov ID
- NCT00557102
- Acronym / sponsor ID
- ERBIFORT / CDR0000574153
- Conditions
- Colorectal Cancer, Metastatic Cancer
- Keywords
- liver metastases, lung metastases, recurrent rectal cancer, stage IV rectal cancer, adenocarcinoma of the rectum, adenocarcinoma of the colon, recurrent colon cancer, stage IV colon cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- National Cancer Institute, FranceOther government
- Collaborators
- University Hospital, Grenoble
- Study start
- Sep 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 12 Nov 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: 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. Drugs used in chemotherapy, such as irinotecan, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with combination chemotherapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cetuximab together with combination chemotherapy works as first-line therapy in treating patients with colorectal cancer that has spread to the liver and/or lung.
Detailed description
OBJECTIVES:
Primary
- Determine the tumor response rate in patients with colorectal cancer and hepatic and/or pulmonary metastases treated with cetuximab and FOLFIRI chemotherapy comprising irinotecan hydrochloride, leucovorin calcium, and fluorouracil as first-line therapy.
Secondary
- Determine the rate of resectability in patients treated with this regimen.
- Determine the overall and disease-free survival of patients treated with this regimen.
- Determine the tolerability of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV over 60-120 minutes on days 1 and 8. Patients also receive FOLFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 48 hours on days 1 and 2. Patients with 7/6 or 7/7 genotypes also receive filgrastim (G-CSF) as primary prophylaxis (patients with 6/6 genotypes receive G-CSF as secondary prophylaxis). Treatment repeats every 2 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity. Within 6 weeks after the completion of cetuximab and FOLFIRI chemotherapy, patients with responding disease undergo surgical resection of visceral metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cetuximab, FOLFIRI | Other | Biological: cetuximab, Biological: filgrastim, Drug: fluorouracil, Drug: irinotecan hydrochloride, Drug: leucovorin calcium |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 | cetuximab, FOLFIRI |
| filgrastim | Biological | cetuximab, FOLFIRI |
| fluorouracil | Drug | cetuximab, FOLFIRI |
| irinotecan hydrochloride | Drug | cetuximab, FOLFIRI |
| leucovorin calcium | Drug | cetuximab, FOLFIRI |
Primary outcome
Tumor response rate
Time frame: From baseline to end of treatment
3 secondary outcomes
Rate of resectability
Time frame: From baseline to end of treatment
Overall and disease-free survival
Time frame: From baseline to end of treatment
Tolerability
Time frame: From baseline to end of treatment
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 11 Dec 2012.
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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 Marc Phelip, MD, PhD study chair
University Hospital, Grenoble
1 site 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, filgrastim and fluorouracil in people with Colorectal Cancer and Metastatic Cancer, run by National Cancer Institute, France 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?
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 11 Dec 2012. 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 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 rate (time frame: From baseline to end of treatment). 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 11 Dec 2012.