Colorectal CancerPhase 2COCHISENCT00766142
Chemotherapy and Cetuximab in Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer
A Phase 2 study testing cetuximab, fluorouracil and leucovorin calcium in people with Colorectal Cancer and Primary Peritoneal Cavity Cancer, run by Institut Bergonié at 1 site in France.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, 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. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Colorectal Cancer, Primary Peritoneal Cavity Cancer
- What is being tested?
- cetuximab, fluorouracil and leucovorin calcium
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2007to 17 Sep 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed colorectal adenocarcinoma meeting the following criteria:
- Exclusively peritoneal carcinomatosis (no other metastases)
- Resectable disease
- Primary tumor may be same in the same location as another synchronous carcinomatosis
- Patients with metastatic disease who have been in complete remission for more than 1 year are eligible regardless of prior chemotherapy
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- Life expectancy ≥ 12 weeks
- ANC ≥ 1.5 x 10^9/L
- Platelet count ≥ 100 x 10^9/L
- Hemoglobin ≥ 10 g/dL
- Bilirubin ≤ 1.25 times upper limit of normal (ULN)
- AST and ALT ≤ 3 times ULN
- Creatinine ≤ 1.25 times ULN
- Creatinine clearance ≥ 30 mL/min
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No allergy, hypersensitivity, or other contraindication to leucovorin calcium, oxaliplatin, or fluorouracil
- No other noncancerous disease that would preclude study therapy
- Good nutritional status
- No sensitive peripheral neuropathy with functional impairment
- No hypoplasia or bone marrow failure
- No clinically significant cardiovascular disease within the past year (e.g., unstable angina or myocardial infarction)
- No other cancer within the past 5 years unless in complete remission with the exception of cervical carcinoma in situ or basal cell cancer
- No patients deprived of liberty or under supervision
- No psychological, social, familial, or geographical reasons prohibiting follow-up
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 1 year since prior adjuvant chemotherapy, including prior therapy with oxaliplatin and/or cetuximab
- No prophylactic phenytoin (Dihydan®, Dilantin®)
- No prior yellow fever vaccine
- More than 1 month since participation in another study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Phase II Study Evaluating Systemic Chemotherapy in Combination With Cetuximab as Adjuvant Treatment in Patients With Completely Surgically Resected Peritoneal Carcinomatosis of Colorectal Origin
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, 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. 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) together with cetuximab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well chemotherapy given together with cetuximab works in treating patients undergoing surgery to remove peritoneal carcinomatosis from colorectal cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the efficacy of systemic chemotherapy and cetuximab, in terms of progression-free survival at 3 years, in patients with completely resected peritoneal carcinomatosis of colorectal origin.
Secondary
- Determine the therapeutic strategy among patients who are or are not fit to receive chemotherapy.
- Determine progression-free survival at 5 years and overall survival at 3 and 5 years in these patients.
- Determine the overall tolerability (mortality, morbidity) of this regimen, including surgery, in these patients.
OUTLINE: This is a multicenter study.
Patients undergo complete resection of the peritoneal carcinomatosis. Beginning 4-8 weeks after surgery, patients receive cetuximab IV over 2.5 hours. Patients also receive FOLFOX chemotherapy comprising oxaliplatin IV and leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours. Treatment repeats every 2 weeks for up to 12 courses.
After completion of study therapy, patients are followed every 4 months for 2 years and then every 6 months for 3 years.
- Being tested
- cetuximab, fluorouracil, leucovorin calcium, oxaliplatin, adjuvant therapy
- Keywords
- adenocarcinoma of the colon, recurrent colon cancer, stage IV colon cancer, adenocarcinoma of the rectum, recurrent rectal cancer, stage IV rectal cancer, peritoneal carcinomatosis
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms, Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cetuximabBiological
fluorouracilDrug
oxaliplatinDrug
adjuvant therapyProcedure or surgery
therapeutic conventional surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy + Cetuximab | Experimental | Surgery + Chemotherapy + Cetuximab Receives: Biological: cetuximab; Drug: fluorouracil; Drug: leucovorin calcium; Drug: oxaliplatin; Procedure: adjuvant therapy; Procedure: therapeutic conventional surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Progression-free Survival (PFS) Time
Progression-free survival time is defined as the time from the date of surgery to the date of progression (as per RECIST v1.1) or death of any cause, whichever occurs first.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: Since surgery, up to 5 years
Secondary outcomes (3)
30-day Mortality Rate
Rate of deaths observed within 30 days of surgery
Measured: from the date of surgery up to 30 days
Mean Number of Adverse Events Per Patient, Within 30 Days of Surgery
Measured: from the date of surgery up to 30 days
Overall Survival (OS) Time
OS is the delay between surgery and death
Measured: from surgery, up to five years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2008 (estimated)
- Study start1 May 2007
- Primary completion17 Sep 2013
- Study completion17 Sep 2013
Why it stopped: In 2008, new data highlighted that Cetuximab had no efficacy in case of KRAS mutation. As such, eligibility criteria were revised and limited to KRAS wild-type. Inclusions were thus slown down considerably, and the trial was stopped.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Combination Chemotherapy and Cetuximab in Treating Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris, Centre Alexis Vautrin, Nancy, Centre Leon Berard, Institut Cancerologie de l'Ouest, Hôpital Haut-Lévêque, Clinique Médicale de Francheville
- Responsible party
- Sponsor
- Investigators
- Serge Evrard, Study chair, Institut Bergonié
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00766142
- Sponsor's protocol ID
- IB-2007-20
- Other IDs
- IB-COCHISE-I, EUDRACT-2006-003900, MERCK-IB-COCHISE-I
- Acronym
- COCHISE
- Status last verified
- Jan 2021
- First submitted
- 2 Oct 2008
- Last updated
- 29 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Evrard S, Desolneux G, Bellera C, Esnaud T, Becouarn Y, Collet D, Chafai N, Marchal F, Cany L, Lermite E, Rivoire M, Mathoulin-Pelissier S. Systemic chemotherapy plus cetuximab after complete surgery in the treatment of isolated colorectal peritoneal carcinoma: COCHISE phase II clinical trial. BMC Res Notes. 2019 Jul 22;12(1):450. doi: 10.1186/s13104-019-4476-9.
PubMed 31331370
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Phase II Study Evaluating Systemic Chemotherapy in Combination With Cetuximab as Adjuvant Treatment in Patients With Completely Surgically Resected Peritoneal Carcinomatosis of Colorectal Origin
- ClinicalTrials.gov ID
- NCT00766142
- Acronym / sponsor ID
- COCHISE / IB-2007-20
- Keywords
- adenocarcinoma of the colon, recurrent colon cancer, stage IV colon cancer, adenocarcinoma of the rectum, recurrent rectal cancer, stage IV rectal cancer, peritoneal carcinomatosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: In 2008, new data highlighted that Cetuximab had no efficacy in case of KRAS mutation. As such, eligibility criteria were revised and limited to KRAS wild-type. Inclusions were thus slown down considerably, and the trial was stopped.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris, Centre Alexis Vautrin, Nancy, Centre Leon Berard, Institut Cancerologie de l'Ouest, Hôpital Haut-Lévêque, Clinique Médicale de Francheville
- Study start
- 1 May 2007
- Primary completion
- 17 Sep 2013 (actual)
- Study completion
- 17 Sep 2013 (actual)
- First posted
- 3 Oct 2008 (estimated)
- Results
- Posted 26 Jan 2021
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 oxaliplatin, 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. 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) together with cetuximab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well chemotherapy given together with cetuximab works in treating patients undergoing surgery to remove peritoneal carcinomatosis from colorectal cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the efficacy of systemic chemotherapy and cetuximab, in terms of progression-free survival at 3 years, in patients with completely resected peritoneal carcinomatosis of colorectal origin.
Secondary
- Determine the therapeutic strategy among patients who are or are not fit to receive chemotherapy.
- Determine progression-free survival at 5 years and overall survival at 3 and 5 years in these patients.
- Determine the overall tolerability (mortality, morbidity) of this regimen, including surgery, in these patients.
OUTLINE: This is a multicenter study.
Patients undergo complete resection of the peritoneal carcinomatosis. Beginning 4-8 weeks after surgery, patients receive cetuximab IV over 2.5 hours. Patients also receive FOLFOX chemotherapy comprising oxaliplatin IV and leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours. Treatment repeats every 2 weeks for up to 12 courses.
After completion of study therapy, patients are followed every 4 months for 2 years and then every 6 months for 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Combination Chemotherapy and Cetuximab in Treating Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy + Cetuximab | Experimental | Biological: cetuximab, Drug: fluorouracil, Drug: leucovorin calcium, Drug: oxaliplatin, Procedure: adjuvant therapy, Procedure: therapeutic conventional surgerySurgery + Chemotherapy + Cetuximab |
Who may qualify
- Ages
- 18 to 120 years
- 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 | Chemotherapy + Cetuximab |
| fluorouracil | Drug | Chemotherapy + Cetuximab |
| leucovorin calcium | Drug | Chemotherapy + Cetuximab |
| oxaliplatin | Drug | Chemotherapy + Cetuximab |
| adjuvant therapy | Procedure or surgery | Chemotherapy + Cetuximab |
| therapeutic conventional surgery | Procedure or surgery | Chemotherapy + Cetuximab |
Primary outcome
Median Progression-free Survival (PFS) Time
Time frame: Since surgery, up to 5 years
Progression-free survival time is defined as the time from the date of surgery to the date of progression (as per RECIST v1.1) or death of any cause, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
3 secondary outcomes
30-day Mortality Rate
Time frame: from the date of surgery up to 30 days
Mean Number of Adverse Events Per Patient, Within 30 Days of Surgery
Time frame: from the date of surgery up to 30 days
Overall Survival (OS) Time
Time frame: from surgery, up to five years.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31331370Evrard S, Desolneux G, Bellera C, Esnaud T, Becouarn Y, Collet D, Chafai N, Marchal F, Cany L, Lermite E, Rivoire M, Mathoulin-Pelissier S. Systemic chemotherapy plus cetuximab after complete surgery in the treatment of isolated colorectal peritoneal carcinoma: COCHISE phase II clinical trial. BMC Res Notes. 2019 Jul 22;12(1):450. doi: 10.1186/s13104-019-4476-9.
- Individual participant dataSharing planned: No
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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.
Serge Evrard study chair
Institut Bergonié
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, fluorouracil and leucovorin calcium in people with Colorectal Cancer and Primary Peritoneal Cavity Cancer, run by Institut Bergonié 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: stopped early, as of the sponsor's last update on 29 Aug 2025. 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?
Yes. Results are posted in the registry (first posted 26 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Median Progression-free Survival (PFS) Time (time frame: Since surgery, up to 5 years). 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 NCT00766142, which also lists 1 linked publication.
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 29 Aug 2025.