Colorectal CancerPhase 2NCT01068132
Prognostic Factors for Patients With Advanced Colorectal Cancer Treated With Cetuximab.
A Phase 2 study testing Cetuximab and FOLFIRI in people with Colorectal Cancer, run by Regione Lombardia at 7 sites in Italy.
Trial summary
Italian, multicentre, non comparative trial in patients with advanced Colorectal Cancer(CRC)and KRAS wild-type, defined by molecular evaluation. Patients will receive Cetuximab + FOLFIRI until disease progression, unacceptable toxicity developed or patient refusal. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Cetuximab and FOLFIRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 7 sitesItaly
- Study dates
- Apr 2009to Oct 2013
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent for biological analysis (all pts)
- Signed written informed consent for enrolment (pts with KRAS wild type)
- Male or female aged > or = 18 years
- Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
- KRAS evaluation availability with wild-type result
- Metastatic CRC not suitable for curative-intent resection
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- Availability of tumour samples (or able and willing to provide tumour sample) and blood for biological analysis
- Presence of at least one lesion measurable unidimensionally by computed tomography (CT) scan or magnetic resonance imaging (MRI). (index lesion(s) must not lie within an irradiated area)
- Eastern cooperative oncology group-performance status (ECOG-PS) <2
Who cannot join
- Brain metastasis (known or suspected)
- Previous chemotherapy for metastatic CRC (any). Adjuvant therapy is allowed if the chemotherapy treatment free interval is > 6 months
- Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to study entry
- Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
- Any investigational agent(s) within 4 weeks prior to entry
- Previous exposure to HER-axis -pathway targeting therapy
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- Leucocytes <3.0 x 109/L and neutrophils <1.5 x 109/L, platelets <100 x 109/L, and hemoglobin <9 g/dL
- Bilirubin level either normal or >1.5 x ULN
- ASAT and ALAT >2.5 x ULN (>5 x ULN if liver metastasis are present)
- Serum creatinine >1.5 x ULN
- Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months
- Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease
- Pre-existing neuropathy > grade 1
- Known grade 3 or 4 allergic reaction to any of the components of the treatment
- Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Pts with a previous malignancy but without evidence of disease for > or equal 5 years will be allowed to enter the trial)
- Pregnancy or lactation
- Inadequate contraception (male or female pts) if of childbearing or procreational potential
- Known drug abuse/ alcohol abuse
- Legal incapacity or limited legal capacity
- Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Italy7 sites
Ospedali Riuniti di Bergamo
Bergamo, Bergamo, 24128
IRCCS San Raffaele
Milan, Milano, 20132
Istututo Clinico Humanitas
Rozzano, Milano, 20086
Ospedale di Saronno
Saronno, Varese, 21047
Ospedale Morelli Sondalo
Sondalo, Sondrio, 23035
Ospedale di Sondrio
Sondrio, Sondrio, 23100
Ospedale di Treviglio e Caravaggio
Treviglio, Bergamo, 24047
About this study
Official title: Prognostic Factors for Patients With Advanced Colorectal Cancer Treated With Cetuximab. An Italian Trial
Italian, multicentre, non comparative trial in patients with advanced Colorectal Cancer(CRC)and KRAS wild-type, defined by molecular evaluation.
Patients will receive Cetuximab + FOLFIRI until disease progression, unacceptable toxicity developed or patient refusal.
Read more
The aim of this study is to assess the prognostic role of PTEN in terms of Progression free survival.
Although the role of Cetuximab as first line treatment in metastatic CRC will be soon established, it is still unclear which is the best schedule for Cetuximab and the role of biological factors in order to select the most appropriate subset of pts for recommending Cetuximab. The data supporting a benefit of Cetuximab in KRAS wild-type pts open the perspective to study the role of other molecular markers in this subset of pts.
On the basis of these considerations this study is aimed at testing a different schedule of Cetuximab and better characterize the prognosis of pts for which Cetuximab is appropriate.
Read the detailed description
Pts meeting eligibility criteria will be registered, providing the availability of material for molecular analysis. Tumour specimens and blood sample will be collected to perform genomic, ICH and proteomic analyses in order to identify the molecular characteristics of tumour.
After the availability of KRAS evaluation, only the data of KRAS wild-type pts will be collected.
Access to registration system will be allowed via web.
Patients,KRAS wild-type receive:
- Cetuximab+FOLFIRI: cetuximab 500 mg/ m² starting dose, following everytwo- week doses of 500 mg/ m², given d1, followed after 1 hour by FOLFIRI: irinotecan 180 mg/m2 on day 1 with LV 100 mg/m2 administered as a 2-hour infusion before FU 400 mg/m2 administered as an intravenous bolus injection, and FU 600 mg/m2 as a 22-hour infusion immediately after FU bolus injection on days 1 and 2
- Conditions
- Colorectal Cancer
- Being tested
- Cetuximab, FOLFIRI
- Keywords
- Colorectal Neoplasms, KRAS, PTEN
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
cetuximab 500 mg/ m² starting dose, following everytwo- week doses of 500 mg/ m², given d1,
FOLFIRIDrug
irinotecan 180 mg/m2 on day 1 with LV 100 mg/m2 administered as a 2-hour infusion before FU 400 mg/m2 administered as an intravenous bolus injection, and FU 600 mg/m2 as a 22-hour infusion immediately after FU bolus injection on days 1 and 2
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Cetuximab+FOLFIRI: cetuximab 500 mg/ m² starting dose, following everytwo- week doses of 500 mg/ m², given d1, followed after 1 hour by FOLFIRI: irinotecan 180 mg/m2 on day 1 with LV 100 mg/m2 administered as a 2-hour infusion before FU 400 mg/m2 administered as an intravenous bolus injection, and FU 600 mg/m2 as a 22-hour infusion immediately after FU bolus injection on days 1 and 2 Receives: Drug: Cetuximab; Drug: FOLFIRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: untill 48 months
Secondary outcomes (1)
Overall survival
Measured: untill 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2010 (estimated)
- Study startApr 2009
- Primary completionOct 2013
- Study completionOct 2013
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regione Lombardia
- Sponsor type
- University, hospital or other
- Collaborators
- Mario Negri Institute for Pharmacological Research, Istituto Clinico Humanitas, A.O. Ospedale Papa Giovanni XXIII
- Responsible party
- Sponsor
- Investigators
- Roberto Labianca, MD, Principal investigator, A.O. Ospedale Papa Giovanni XXIIIArmando Santoro, MD, Principal investigator, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01068132
- Sponsor's protocol ID
- 2008-007524-25
- Other IDs
- 2008
- Status last verified
- May 2014
- First submitted
- 4 May 2009
- Last updated
- 12 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Factors for Patients With Advanced Colorectal Cancer Treated With Cetuximab. An Italian Trial
- ClinicalTrials.gov ID
- NCT01068132
- Acronym / sponsor ID
- 2008-007524-25
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Neoplasms, KRAS, PTEN
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Regione LombardiaUniversity, hospital or other
- Collaborators
- Mario Negri Institute for Pharmacological Research, Istituto Clinico Humanitas, A.O. Ospedale Papa Giovanni XXIII
- Study start
- Apr 2009
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 12 Feb 2010 (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.
Italian, multicentre, non comparative trial in patients with advanced Colorectal Cancer(CRC)and KRAS wild-type, defined by molecular evaluation.
Patients will receive Cetuximab + FOLFIRI until disease progression, unacceptable toxicity developed or patient refusal.
The aim of this study is to assess the prognostic role of PTEN in terms of Progression free survival.
Although the role of Cetuximab as first line treatment in metastatic CRC will be soon established, it is still unclear which is the best schedule for Cetuximab and the role of biological factors in order to select the most appropriate subset of pts for recommending Cetuximab. The data supporting a benefit of Cetuximab in KRAS wild-type pts open the perspective to study the role of other molecular markers in this subset of pts.
On the basis of these considerations this study is aimed at testing a different schedule of Cetuximab and better characterize the prognosis of pts for which Cetuximab is appropriate.
Detailed description
Pts meeting eligibility criteria will be registered, providing the availability of material for molecular analysis. Tumour specimens and blood sample will be collected to perform genomic, ICH and proteomic analyses in order to identify the molecular characteristics of tumour.
After the availability of KRAS evaluation, only the data of KRAS wild-type pts will be collected.
Access to registration system will be allowed via web.
Patients,KRAS wild-type receive:
- Cetuximab+FOLFIRI: cetuximab 500 mg/ m² starting dose, following everytwo- week doses of 500 mg/ m², given d1, followed after 1 hour by FOLFIRI: irinotecan 180 mg/m2 on day 1 with LV 100 mg/m2 administered as a 2-hour infusion before FU 400 mg/m2 administered as an intravenous bolus injection, and FU 600 mg/m2 as a 22-hour infusion immediately after FU bolus injection on days 1 and 2
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Cetuximab, Drug: FOLFIRICetuximab+FOLFIRI: cetuximab 500 mg/ m² starting dose, following everytwo- week doses of 500 mg/ m², given d1, followed after 1 hour by FOLFIRI: irinotecan 180 mg/m2 on day 1 with LV 100 mg/m2 administered as a 2-hour infusion before FU 400 mg/m2 administered as an intravenous bolus injection, and FU 600 mg/m2 as a 22-hour infusion immediately after FU bolus injection on days 1 and 2 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed written informed consent for biological analysis (all pts)
- Signed written informed consent for enrolment (pts with KRAS wild type)
- Male or female aged > or = 18 years
- Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
- KRAS evaluation availability with wild-type result
Key exclusion criteria (20 listed)
- Brain metastasis (known or suspected)
- Previous chemotherapy for metastatic CRC (any). Adjuvant therapy is allowed if the chemotherapy treatment free interval is > 6 months
- Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to study entry
- Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
- Any investigational agent(s) within 4 weeks prior to entry
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 |
|---|---|---|
| Cetuximabcetuximab 500 mg/ m² starting dose, following everytwo- week doses of 500 mg/ m², given d1, | Drug | 1 |
| FOLFIRIirinotecan 180 mg/m2 on day 1 with LV 100 mg/m2 administered as a 2-hour infusion before FU 400 mg/m2 administered as an intravenous bolus injection, and FU 600 mg/m2 as a 22-hour infusion immediately after FU bolus injection on days 1 and 2 | Drug | 1 |
Primary outcome
Progression free survival
Time frame: untill 48 months
1 secondary outcome
Overall survival
Time frame: untill 48 months
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 12 May 2014.
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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.
Roberto Labianca, MD principal investigator
A.O. Ospedale Papa Giovanni XXIII
Armando Santoro, MD principal investigator
Istituto Clinico Humanitas
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 and FOLFIRI in people with Colorectal Cancer, run by Regione Lombardia at 7 sites in Italy.
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 9 inclusion and 20 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 12 May 2014. 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 Italy. 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?
Progression free survival (time frame: untill 48 months). 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 12 May 2014.