Metastatic Colorectal CancerNCT01437618
First-line FOLFOXIRI Plus Bevacizumab in BRAF Mutant Metastatic Colorectal Cancer
An observational study of Metastatic Colorectal Cancer, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
Trial summary
The purpose of this study is to prospectively verify if FOLFOXIRI plus bevacizumab as first-line treatment could be considered a promising approach to improve the outcome of BRAF mutant metastatic colorectal cancer patients Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- FOLFOXIRI plus bevacizumab
- Type of treatment
- Injection or infusion
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2009to May 2011
- Phase
- Observational
- 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
Study population: BRAF mutant mCRC
Who may be able to join
- Histologically confirmed colorectal adenocarcinoma;
- Availability of formalin-fixed paraffin embedded tumor block from primary and/or metastasis;
- BRAF V600E mutant status of primary colorectal cancer and/or related metastasis;
- Unresectable and measurable metastatic disease according to RECIST criteria;
- Male or female, aged > 18 years and < 75 years;
- ECOG PS < 2 if aged < 71 years;
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- ECOG PS = 0 if aged 71-75 years;
- Life expectancy of more than 3 months;
- Adequate haematological function: ANC ≥ 1.5 x 10^9/L; platelets ≥ 100 x 10^9/L, Hb ≥ 9 g/dL;
- Adequate liver function: serum bilirubin ≤ 1.5 x ULN; alkaline phosphatase and transaminases ≤ 2.5 x ULN (in case of liver metastases ≤ 5 x ULN);
- Serum creatinine ≤ 1.5 x ULN;
- Previous adjuvant chemotherapy is allowed if more than 12 months have elapsed between the end of adjuvant therapy and first relapse;
- At least 6 weeks from prior extended radiotherapy and 4 weeks from surgery;
- Written informed consent to experimental treatment and molecular analyses.
Who cannot join
- Presence or history of CNS metastasis;
- Serious, non-healing wound, ulcer, or bone fracture;
- Evidence of bleeding diathesis or coagulopathy;
- Uncontrolled hypertension;
- Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (CVA) (≤6 months before treatment start), myocardial infarction (≤ 6 months before treatment start), unstable angina, NYHA ≥ grade 2 chronic heart failure (CHF), uncontrolled arrhythmia;
- Current or recent (within 10 days prior to study treatment start) ongoing treatment with anticoagulants for therapeutic purposes;
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- Chronic, daily treatment with high-dose aspirin (>325 mg/day);
- Symptomatic peripheral neuropathy ≥ 2 grade NCIC-CTG criteria;
- Active uncontrolled infections;
- Treatment with any investigational drug within 30 days prior to enrolment;
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of curatively treated basal and squamous cell carcinoma of the skin or in situ cancer of the cervix;
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start;
- Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome;
- Fertile women (< 2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: FOLFOXIRI Plus Bevacizumab as First-line Treatment for BRAF V600E Mutant Metastatic Colorectal Cancer: a Prospective Evaluation
The purpose of this study is to prospectively verify if FOLFOXIRI plus bevacizumab as first-line treatment could be considered a promising approach to improve the outcome of BRAF mutant metastatic colorectal cancer patients
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- FOLFOXIRI plus bevacizumab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFOXIRI plus bevacizumabDrug
- BEVACIZUMAB 5 mg/Kg i.v. over 30', day 1 followed by
- IRINOTECAN 165 mg/sqm i.v. over 1-h, day 1 followed by
- OXALIPLATIN 85 mg/sqm i.v. over 2-h, day 1 concomitantly with
- l-LV 200 mg/sqm i.v. over 2-h, day 1 followed by
- 5-FLUOROURACIL 3200 mg/sqm i.v. 48-h continuous infusion, starting on day 1 Cycles repeated every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| BRAF mutant mCRC | Not described Receives: Drug: FOLFOXIRI plus bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
Measured: About 24-30 months (From treatment initiation to evidence of progression or death from any cause)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2011 (estimated)
- Study startJun 2009
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero, Universitaria Pisana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfredo Falcone, Azienda Ospedaliero, Universitaria Pisana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01437618
- Sponsor's protocol ID
- BRAF-0809-TRIBV
- Status last verified
- Sep 2011
- First submitted
- 12 Jul 2011
- Last updated
- 21 Sep 2011
- Results posted
- No
Publications
Loupakis F, Cremolini C, Salvatore L, Masi G, Sensi E, Schirripa M, Michelucci A, Pfanner E, Brunetti I, Lupi C, Antoniotti C, Bergamo F, Lonardi S, Zagonel V, Simi P, Fontanini G, Falcone A. FOLFOXIRI plus bevacizumab as first-line treatment in BRAF mutant metastatic colorectal cancer. Eur J Cancer. 2014 Jan;50(1):57-63. doi: 10.1016/j.ejca.2013.08.024. Epub 2013 Oct 15.
PubMed 24138831
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FOLFOXIRI Plus Bevacizumab as First-line Treatment for BRAF V600E Mutant Metastatic Colorectal Cancer: a Prospective Evaluation
- ClinicalTrials.gov ID
- NCT01437618
- Acronym / sponsor ID
- BRAF-0809-TRIBV
- Conditions
- Metastatic Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Azienda Ospedaliero, Universitaria PisanaUniversity, hospital or other
- Study start
- Jun 2009
- Study completion
- May 2011 (actual)
- First posted
- 21 Sep 2011 (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 prospectively verify if FOLFOXIRI plus bevacizumab as first-line treatment could be considered a promising approach to improve the outcome of BRAF mutant metastatic colorectal cancer patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BRAF mutant mCRC | – | Drug: FOLFOXIRI plus bevacizumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- BRAF mutant mCRC
Key inclusion criteria (14 listed)
- Histologically confirmed colorectal adenocarcinoma;
- Availability of formalin-fixed paraffin embedded tumor block from primary and/or metastasis;
- BRAF V600E mutant status of primary colorectal cancer and/or related metastasis;
- Unresectable and measurable metastatic disease according to RECIST criteria;
- Male or female, aged > 18 years and < 75 years;
Key exclusion criteria (14 listed)
- Presence or history of CNS metastasis;
- Serious, non-healing wound, ulcer, or bone fracture;
- Evidence of bleeding diathesis or coagulopathy;
- Uncontrolled hypertension;
- Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (CVA) (≤6 months before treatment start), myocardial infarction (≤ 6 months before treatment start), unstable angina, NYHA ≥ grade 2 chronic heart failure (CHF), uncontrolled arrhythmia;
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 |
|---|---|---|
| FOLFOXIRI plus bevacizumab* BEVACIZUMAB 5 mg/Kg i.v. over 30', day 1 followed by * IRINOTECAN 165 mg/sqm i.v. over 1-h, day 1 followed by * OXALIPLATIN 85 mg/sqm i.v. over 2-h, day 1 concomitantly with * l-LV 200 mg/sqm i.v. over 2-h, day 1 followed by * 5-FLUOROURACIL 3200 mg/sqm i.v. 48-h continuous infusion, starting on day 1 Cycles repeated every 2 weeks | Drug | BRAF mutant mCRC |
Primary outcome
Progression-Free Survival
Time frame: About 24-30 months (From treatment initiation to evidence of progression or death from any cause)
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 21 Sep 2011.
- Derived from this study: PubMed 24138831Loupakis F, Cremolini C, Salvatore L, Masi G, Sensi E, Schirripa M, Michelucci A, Pfanner E, Brunetti I, Lupi C, Antoniotti C, Bergamo F, Lonardi S, Zagonel V, Simi P, Fontanini G, Falcone A. FOLFOXIRI plus bevacizumab as first-line treatment in BRAF mutant metastatic colorectal cancer. Eur J Cancer. 2014 Jan;50(1):57-63. doi: 10.1016/j.ejca.2013.08.024. Epub 2013 Oct 15.
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CRC
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer, run by Azienda Ospedaliero, Universitaria Pisana at 1 site 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 14 inclusion and 14 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 21 Sep 2011. 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 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.
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: About 24-30 months (From treatment initiation to evidence of progression or death from any cause)). 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 NCT01437618, 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 21 Sep 2011.