Colorectal CancerPhase 2NCT00202787
Safety and Efficacy Study of Combination Therapy With Cetuximab and FOLFOX4 in Patients With Colorectal Cancer
A Phase 2 study testing FOLFOX-4+cetuximab and FOLFOX-4 in people with Colorectal Cancer, run by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) at 1 site in Spain.
Trial summary
The purpose of this study is to determine confirmed objective response rate to combination therapy with cetuximab and FOLFOX4 or FOLFOX4 alone in patients with CRC and non-resectable hepatic metastases Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- FOLFOX-4+cetuximab and FOLFOX-4
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2005to Feb 2009
- 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
- Written informed consent.
- Men and women < 75 years
- Histologically confirmed diagnosis of CRC
- Metastatic colorectal carcinoma with exclusive non-resectable hepatic metastases, due to fulfillment of one of the following criteria:
- Number of hepatic metastases > or= 4;
- Size of one or more hepatic metastases > 5 cm diameter;
Show all 19Show fewer
- Vascular involvement and/or poor site that prevent complete resection of hepatic disease and/or require resection with the remaining liver mass less than 25-30% of functional liver.
- Presence of at least one lesion detectable by two-dimensional measurement.
- Karnofsky functional status >or=70% at the time of enrollment in study
- Life expectancy greater than 3 months.
- Patients must not have received chemotherapy for advanced/metastatic disease.
- Patients with the following characteristics will be enrolled:
- Recurrence after adjuvant treatment with 5-fluorouracil/folinic acid or capecitabine +/- radiotherapy with disease-free period > 6 months following conclusion of treatment.
- Recurrence after surgical and/or radiotherapy treatment without adjuvant systemic treatment.
- De novo diagnosis of disease.
- Proper liver function, defined by aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) < or = 2.5 x ULN (< or = 5 x ULN if there are hepatic metastases) and total bilirubin count < 1.5 x ULN.
- Proper kidney function, defined as serum creatinine < 1.5 x ULN.
- Proper hematological function, defined as neutrophil count > or = 1.5 x 109/l , platelets > or = 100 X 109/l and hemoglobin > or = 9 g/dl.
- Effective birth control method for men as well as women if there is possibility of pregnancy
Who cannot join
- Documented or suspected cerebral and/or leptomeningeal metastases.
- Metastasis in any other non-hepatic site, including extrahepatic lymph node metastases.
- Surgery (excluding biopsy for diagnosis) and/or radiotherapy within 4 weeks prior to enrollment in the study.
- Participation in another clinical trial with medication in the past 30 days.
- Chronic, concomitant administration of systemic immunotherapy, chemotherapy, hormone therapy or any other investigational drug.
- Prior malignant tumour in past 5 years, except history of basal cell skin carcinoma or pre-invasive cervical carcinoma.
Show all 16Show fewer
- Any investigational drug during the 4 weeks prior to enrolment.
- Prior administration of monoclonal antibodies, EGFR signal transduction inhibitors or EGFR-targeted treatment.
- Prior participation in study in which treatment with cetuximab can be assigned (whether or not treatment with cetuximab is received)
- Acute or subacute intestinal occlusion or history of inflammatory intestinal disease.
- Evidence of grade 3 or 4 allergic reaction to any of the treatment components.
- Clinically relevant peripheral neuropathy.
- Clinically relevant myocardial disease or history of myocardial infarction in the past 12 months.
- Known abuse of alcohol / drugs, Legal incapacity or limited legal capacity.
- Any medical or psychological disorder which, in the opinion of the investigator, does not allow the patient to conclude the study or sign the informed consent.
- Pregnant or nursing woman
Trial locations and contacts
1 site in 1 country.
Spain1 site
Spanish Cooperative Group for Gastrointestinal Tumour Therapy (TTD)
Madrid, 28046
About this study
Official title: Open-label, Phase II, Randomised, Pilot Study to Evaluate the Safety and Efficacy of Combination Therapy With Cetuximab and FOLFOX4 or FOLFOX4 Alone in Patients Colorectal Cancer and Initially Non-resectable
The purpose of this study is to determine confirmed objective response rate to combination therapy with cetuximab and FOLFOX4 or FOLFOX4 alone in patients with CRC and non-resectable hepatic metastases
- Conditions
- Colorectal Cancer
- Being tested
- FOLFOX-4+cetuximab, FOLFOX-4
- Keywords
- colorectal cancer, cetuximab, FOLFOX4
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFOX-4+cetuximabDrug
Cetuximab; Weekly administration of Cetuximab IV (initial infusion of 400 mg/m2 for 120 minutes followed by subsequent maintenance doses of 250 mg/m2 for 60 minutes);
FOLFOX-4: Every two week Oxaliplatin; 85 mg/m2 ; day 1 Folinic acid; 200 mg/m2 ; day 1 and 2 5-FU ; Bolus 400 mg/m2 + CI 600 mg/m2 22 h day 1 and 2
FOLFOX-4Drug
FOLFOX-4: Every two week Oxaliplatin; 85 mg/m2 ; day 1 Folinic acid; 200 mg/m2 ; day 1 and 2 5-FU ; Bolus 400 mg/m2 + CI 600 mg/m2 22 h day 1 and 2
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | FOLFOX-4+cetuximab Receives: Drug: FOLFOX-4+cetuximab |
| 2 | Active comparator | FOLFOX-4 Receives: Drug: FOLFOX-4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine confirmed objective response rate
Measured: 2005-2009
Secondary outcomes (2)
Determine safety of combination, surgical resectability and R0 resections, clinical benefit, time to disease progression, time to onset of response, duration of response, time to treatment failure, overall survival time
Measured: 2005-2009
determination of polymorphisms of the intron 1 of the EGFR gene, TS, XRCC1, XPD, serum levels of EGFR and ATP7A and ATP7B, nº of copies of EGFR gene, the levels of PTEN, EGFR, AKT y MAPK proteins, and mutations at EGFR, PI3KCA, K-RAS y B-RAF genes
Measured: 2005-2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startFeb 2005
- Primary completionFeb 2009
- Study completionFeb 2009
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Albert Abad, Study chair, Spanish Cooperative Group for Gastrointestinal Tumour Therapy (TTD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00202787
- Sponsor's protocol ID
- TTD-04-02
- Other IDs
- eudract-number: 2004-001700-12
- Status last verified
- Feb 2013
- First submitted
- 12 Sep 2005
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Phase II, Randomised, Pilot Study to Evaluate the Safety and Efficacy of Combination Therapy With Cetuximab and FOLFOX4 or FOLFOX4 Alone in Patients Colorectal Cancer and Initially Non-resectable
- ClinicalTrials.gov ID
- NCT00202787
- Acronym / sponsor ID
- TTD-04-02
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, cetuximab, FOLFOX4
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Feb 2005
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 20 Sep 2005 (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.
The purpose of this study is to determine confirmed objective response rate to combination therapy with cetuximab and FOLFOX4 or FOLFOX4 alone in patients with CRC and non-resectable hepatic metastases
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: FOLFOX-4+cetuximabFOLFOX-4+cetuximab |
| 2 | Active comparator | Drug: FOLFOX-4FOLFOX-4 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Written informed consent.
- Men and women < 75 years
- Histologically confirmed diagnosis of CRC
- Metastatic colorectal carcinoma with exclusive non-resectable hepatic metastases, due to fulfillment of one of the following criteria:
- Presence of at least one lesion detectable by two-dimensional measurement.
Key exclusion criteria (16 listed)
- Documented or suspected cerebral and/or leptomeningeal metastases.
- Metastasis in any other non-hepatic site, including extrahepatic lymph node metastases.
- Surgery (excluding biopsy for diagnosis) and/or radiotherapy within 4 weeks prior to enrollment in the study.
- Participation in another clinical trial with medication in the past 30 days.
- Chronic, concomitant administration of systemic immunotherapy, chemotherapy, hormone therapy or any other investigational drug.
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 |
|---|---|---|
| FOLFOX-4+cetuximabCetuximab; Weekly administration of Cetuximab IV (initial infusion of 400 mg/m2 for 120 minutes followed by subsequent maintenance doses of 250 mg/m2 for 60 minutes); FOLFOX-4: Every two week Oxaliplatin; 85 mg/m2 ; day 1 Folinic acid; 200 mg/m2 ; day 1 and 2 5-FU ; Bolus 400 mg/m2 + CI 600 mg/m2 22 h day 1 and 2 | Drug | 1 |
| FOLFOX-4FOLFOX-4: Every two week Oxaliplatin; 85 mg/m2 ; day 1 Folinic acid; 200 mg/m2 ; day 1 and 2 5-FU ; Bolus 400 mg/m2 + CI 600 mg/m2 22 h day 1 and 2 | Drug | 2 |
Primary outcome
Determine confirmed objective response rate
Time frame: 2005-2009
2 secondary outcomes
Determine safety of combination, surgical resectability and R0 resections, clinical benefit, time to disease progression, time to onset of response, duration of response, time to treatment failure, overall survival time
Time frame: 2005-2009
determination of polymorphisms of the intron 1 of the EGFR gene, TS, XRCC1, XPD, serum levels of EGFR and ATP7A and ATP7B, nº of copies of EGFR gene, the levels of PTEN, EGFR, AKT y MAPK proteins, and mutations at EGFR, PI3KCA, K-RAS y B-RAF genes
Time frame: 2005-2009
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 20 Feb 2013.
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Albert Abad study chair
Spanish Cooperative Group for Gastrointestinal Tumour Therapy (TTD)
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 FOLFOX-4+cetuximab and FOLFOX-4 in people with Colorectal Cancer, run by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) at 1 site in Spain.
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 19 inclusion and 16 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 20 Feb 2013. 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 Spain. 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?
Determine confirmed objective response rate (time frame: 2005-2009). 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 20 Feb 2013.