Metastatic Colorectal CancerPhase 2NCT02181556
Efficacy and Safety of Aflibercept in Combination With FOLFIRI Chemotherapy as 1st Line Treatment for Patients With Metastatic Colorectal Cancer
A Phase 2 study testing FOLFIRI Protocol and Aflibercept Injection in people with Metastatic Colorectal Cancer, run by Federation Francophone de Cancerologie Digestive at 8 sites in France.
Trial summary
One of the treatments generally used to treat this disease is a chemotherapy called FOLFIRI. The purpose of this study is to improve the efficacy of the chemotherapy by adding a protein, similar to immunoglobulins, aflibercept, and to assess their tolerance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- FOLFIRI Protocol and Aflibercept Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 8 sitesFrance
- Study dates
- Oct 2014to Jul 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Overall state as per WHO (World Health Organization) ≤ 2
- Life expectancy > 3 months
- Metastatic adenocarcinoma of the rectum or of the colon histologically proven on the primary tumor or a metastasis
- Unresectable metastasis (metastases) and/or inoperable patient
- Patient eligible for a 1st line treatment associating 5 FU-Irinotecan (FOLFIRI) and aflibercept
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- At least one measurable target lesion according to RECIST criteria v1.1 not previously irradiated
- Absence of prior treatment of the metastatic disease. Prior adjuvant chemotherapy completed at least 12 months before the metastatic cancer diagnosis is authorized
- Satisfactory laboratory panel: Hb> 9 g/dl, polynuclear neutrophils > 1500 /mm3, platelets > 100,000/mm3, total bilirubin < 1.5 x UNL(upper normal limit), creatinine clearance > 50 mL/min (cockcroft-Gault formula - appendix 4), PAL (alkaline phosphatase) < 5 x UNL, AST (aspartate aminotransferase) and ALT (alanine aminotransferases) < 5 x UNL, GGT (gamma-glutamyltransferase) < 5 x UNL,
- Proteinuria on urine dipstick < 2+. If > 2+ test 24-hour proteinuria, which should be < 1 g
Who cannot join
- Patients whose primary tumor is in place and presenting clinical symptoms (occlusion; hemorrhage)
- Brain metastases
- Gilbert's syndrome
- Uncontrolled hypercalcemia
- Hypertension not kept under control (SBP (Systolic Blood Pressure) >150 mmHg and DBP (Diastolic Blood Pressure) >100 mmHg) or history of hypertensive crisis or hypertensive encephalopathy
- Any unbalanced active disease over the last 6 months: liver failure, kidney failure, respiratory failure, congestive heart failure, unstable angina, myocardial infarction, significant arrhythmia (Patients treated by anticoagulants (coumadin, warfarin) are eligible if strict monitoring of the INR( international normalized ratio) is possible)
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- Significant surgical intervention within the 28 days before the start of treatment
- Presence of active gastroduodenal ulcer, non-healed wound or bone fracture
- Antitumor treatments other than those included in the study (chemotherapy, targeted therapy, immunotherapy)
- History of malignant hemopathy or cancer except for those treated more than 5 years ago and considered healed, in situ carcinomas of the uterine cervix and treated skin cancers (except for melanoma)
- Pregnant or breast-feeding women, women of childbearing age not having taken a pregnancy test, absence of effective contraception in patients (men and/or women) of childbearing age
- Any contraindication of the drugs used in the study
- Impossible to meet the medical follow-up requirements of the study for geographic, social or psychological reasons
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
CHU - Hôtel Dieu
Angers
Hôpital Avicenne
Bobigny, 93000
CHU - Hôpital François Mitterand
Dijon, 21079
Clinique Jean Mermoz
Lyon
La Timone
Marseille, 13000
Hôpital Européen Geaorge Pompidou (HEGP)
Paris, 75020
Hôpital La Pitié Salpetière
Paris
Hôpital Trousseau
Tours, 37044
About this study
One of the treatments generally used to treat this disease is a chemotherapy called FOLFIRI. The purpose of this study is to improve the efficacy of the chemotherapy by adding a protein, similar to immunoglobulins, aflibercept, and to assess their tolerance.
Aflibercept is a protein that has already been studied in the treatment of metastatic colorectal cancers, in combination with a chemotherapy involving irinotecan in addition to 5FU (fluoropyrimidine) ( (FOLFIRI) as 2nd line treatment. It is marketed in Europe and it is authorized in the United States. Its addition to this chemotherapy combination has in fact brought about a benefit in terms of progression-free survival and overall survival.
The purpose of the study is to evaluate the efficacy and tolerance of this combination rather in the initial approach to the treatment of metastatic colorectal cancers and hence to evaluate it as 1st line treatment
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- FOLFIRI Protocol, Aflibercept Injection
- Keywords
- colorectal cancer, Metastatic
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFIRI ProtocolDrug
injection of FOLFIRI and Aflibercept every 14 days until progression of disease
Aflibercept InjectionDrug
injection of FOLFIRI and Aflibercept every 14 days until progression of disease
| Study group | Role | What they receive |
|---|---|---|
| FOLFIRI + Aflibercept | Experimental | FOLFIRI and aflibercept (4 mg/m²) each 14 days until progression of disease Receives: Drug: FOLFIRI Protocol; Drug: Aflibercept Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Patients Alive and Progression-free 6 Months After Inclusion.
Progression was evaluated by CT scan, according to RECIST criteria (version 1.1) definition by the investigator. Death was also considered as an event (all causes).
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions compared the little sum of diameters observed during the study (NADIR), or a measurable increase in a non-target lesion, or the appearance of new lesions
Measured: 6 months
Secondary outcomes (2)
Overall Survival
Overall survival is defined as the time from the date of the patient's inclusion to the patient's death (all causes). For alive patients the date of the latest news is taken into account
Measured: Up to 2 years after the end of the treatment
Progression-free Survival
The progression-free survival is the time from inclusion to the first radiological progression or death (all causes). For patients alive without progression date of last news will be considered.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions compared the little sum of diameters observed durin the study (NADIR), or a measurable increase in a non-target lesion, or the appearance of new lesions
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2014 (estimated)
- Study startOct 2014
- Primary completionFeb 2017
- Study completionJul 2017
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 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federation Francophone de Cancerologie Digestive
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien TAIEB, PhD, Principal investigator, Fédération Francophone de Cancérologie Digestive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02181556
- Sponsor's protocol ID
- FFCD 1302
- Status last verified
- May 2021
- First submitted
- 2 Jul 2014
- Last updated
- 7 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lapeyre-Prost A, Pernot S, Sigrand J, Le Malicot K, Mary F, Aparicio T, Dahan L, Caroli-Bosc FX, Lecomte T, Doat S, Marthey L, Desrame J, Lepage C, Taieb J. Aflibercept in Combination With FOLFIRI as First-line Chemotherapy in Patients With Metastatic Colorectal Cancer (mCRC): A Phase II Study (FFCD 1302). Clin Colorectal Cancer. 2020 Dec;19(4):285-290. doi: 10.1016/j.clcc.2020.06.003. Epub 2020 Jun 12.
PubMed 32921581
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Aflibercept in Combination With FOLFIRI Chemotherapy as 1st Line Treatment for Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02181556
- Acronym / sponsor ID
- FFCD 1302
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- colorectal cancer, Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Federation Francophone de Cancerologie DigestiveUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 4 Jul 2014 (estimated)
- Results
- Posted 7 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One of the treatments generally used to treat this disease is a chemotherapy called FOLFIRI. The purpose of this study is to improve the efficacy of the chemotherapy by adding a protein, similar to immunoglobulins, aflibercept, and to assess their tolerance.
Aflibercept is a protein that has already been studied in the treatment of metastatic colorectal cancers, in combination with a chemotherapy involving irinotecan in addition to 5FU (fluoropyrimidine) ( (FOLFIRI) as 2nd line treatment. It is marketed in Europe and it is authorized in the United States. Its addition to this chemotherapy combination has in fact brought about a benefit in terms of progression-free survival and overall survival.
The purpose of the study is to evaluate the efficacy and tolerance of this combination rather in the initial approach to the treatment of metastatic colorectal cancers and hence to evaluate it as 1st line treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FOLFIRI + Aflibercept | Experimental | Drug: FOLFIRI Protocol, Drug: Aflibercept InjectionFOLFIRI and aflibercept (4 mg/m²) each 14 days until progression of disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years
- Overall state as per WHO (World Health Organization) ≤ 2
- Life expectancy > 3 months
- Metastatic adenocarcinoma of the rectum or of the colon histologically proven on the primary tumor or a metastasis
- Unresectable metastasis (metastases) and/or inoperable patient
Key exclusion criteria (13 listed)
- Patients whose primary tumor is in place and presenting clinical symptoms (occlusion; hemorrhage)
- Brain metastases
- Gilbert's syndrome
- Uncontrolled hypercalcemia
- Hypertension not kept under control (SBP (Systolic Blood Pressure) >150 mmHg and DBP (Diastolic Blood Pressure) >100 mmHg) or history of hypertensive crisis or hypertensive encephalopathy
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 |
|---|---|---|
| FOLFIRI Protocolinjection of FOLFIRI and Aflibercept every 14 days until progression of disease | Drug | FOLFIRI + Aflibercept |
| Aflibercept Injectioninjection of FOLFIRI and Aflibercept every 14 days until progression of disease | Drug | FOLFIRI + Aflibercept |
Primary outcome
Rate of Patients Alive and Progression-free 6 Months After Inclusion.
Time frame: 6 months
Progression was evaluated by CT scan, according to RECIST criteria (version 1.1) definition by the investigator. Death was also considered as an event (all causes). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions compared the little sum of diameters observed during the study (NADIR), or a measurable increase in a non-target lesion, or the appearance of new lesions
2 secondary outcomes
Overall Survival
Time frame: Up to 2 years after the end of the treatment
Progression-free Survival
Time frame: up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32921581Lapeyre-Prost A, Pernot S, Sigrand J, Le Malicot K, Mary F, Aparicio T, Dahan L, Caroli-Bosc FX, Lecomte T, Doat S, Marthey L, Desrame J, Lepage C, Taieb J. Aflibercept in Combination With FOLFIRI as First-line Chemotherapy in Patients With Metastatic Colorectal Cancer (mCRC): A Phase II Study (FFCD 1302). Clin Colorectal Cancer. 2020 Dec;19(4):285-290. doi: 10.1016/j.clcc.2020.06.003. Epub 2020 Jun 12.
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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.
Julien TAIEB, PhD principal investigator
Fédération Francophone de Cancérologie Digestive
8 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 FOLFIRI Protocol and Aflibercept Injection in people with Metastatic Colorectal Cancer, run by Federation Francophone de Cancerologie Digestive at 8 sites in France.
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 10 inclusion and 13 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 7 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 7 Jun 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?
Rate of Patients Alive and Progression-free 6 Months After Inclusion. (time frame: 6 months). 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 NCT02181556, 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 7 Jun 2021.