Aflibercept +/- LV5FU2 in First Line of Non-resectalbe Metastatic Colorectal Cancers (FOLFA)
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|ClinicalTrials.gov Identifier: NCT02384759|
Recruitment Status : Unknown
Verified August 2016 by Federation Francophone de Cancerologie Digestive.
Recruitment status was: Recruiting
First Posted : March 10, 2015
Last Update Posted : August 3, 2016
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Neoplasms||Drug: aflibercept Drug: LV5FU2||Phase 2|
The aflibercept-5-FU combination has never been evaluated as yet. Aflibercept, at a dose of 4 mg/kg, has already been used in combination with 5-FU at the doses used in the simplified LV5FU2 regimen (folinic acid 400 mg/m2 IV in 90 min, then 5-FU 400 mg/m2 IV bolus on D1, followed by continuous perfusion of 5-FU 2,400 mg/m2 in 46h) (23) as part of the above-mentioned VELOUR trial, evaluating its combination with FOLFIRI (= simplified LV5FU2 + irinotecan). This trial was preceded by a phase I trial validating the doses used (24). It is therefore not necessary to perform a phase I trial if you use the same doses of 5-FU without irinotecan, within the context of a strategy for reducing toxicity in patients to be treated over a long period, and not search for the maximum tolerated dose of the combination.
The aflibercept-LV5FU2 combination can be useful for patients who will never be resectable or operable, and for whom 5-FU monotherapy can be suggested to delay the toxicities of combined chemotherapies. Within this context, it is possible for aflibercept to provide a survival benefit. The previous VELOUR trial (18) did not indicate that toxicity would have a major effect on quality of life and increase the hope of prolonged progression-free survival in the arm with aflibercept.
This is what the FFCD 11-01 - PRODIGE 25 trial proposes to study, as a preliminary for strategic studies evaluating the usefulness of including targeted therapeutics from the first line.
This trial will evaluate the efficacy of the combination and its tolerance by studying toxicities and quality of life. Quality of life will be studied via the EORTC questionnaire QLQ-C30.
The thymidylate synthase polymorphism type 2R2R-2R3R versus 3R3R seems to predict greater efficacy of 5-FU monotherapy. Stratification in this criterion will confirm or negate the prognostic or predictive nature of 5-FU efficacy linked to these polymorphisms.
The draft version of this trial has been studied and evaluated by the scientific council of the Fédération Francophone de Cancérologie Digestive (FFCD) then the Digestive Group of the Fédération Nationale des Centres de Lutte Contre le Cancer (FNCLCC) within the framework of their Partnership for Research in Digestive Oncology (PRODIGE cooperation).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||118 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Randomized Trial Evaluting Aflibercept Associated With LV5FU2 Regimen as First Line Treatment of Non-resectalbe Metastatic Colorectal Cancers|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||July 2018|
Aflibercept + LV5FU2
Other Name: zaltrap
Active Comparator: B
- Radiological progression-free survival according to the investigator [ Time Frame: up to 6 months ]Efficacy of aflibercept combined with 5-FU monotherapy, on progression-free (radiological only) survival within 6 months after the randomization, according to the investigator.
- Aflibercept tolerance withe LV5FU2 [ Time Frame: up to 6 months, 2 years and 3 years ]Aflibercept tolerance in combination with 5-FU and folinic acid, evaluated by toxicities graded according to NCI-CTC V4.0
- Quality of life [ Time Frame: up to 6 months, 2 years and 3 years ]Quality of life using the EORTC QLQ-C30 questionnaire and time to final deterioration in quality of life
- Overall survival [ Time Frame: up to 1 year ]
- Radiological progression-free survival accordint to central reading [ Time Frame: up to 6 months ]Proportion of patients alive and without progression (radiological) within 6 months (RECIST 1.1) according to central reading
- Clinical and radiological progression-free survival according to the investigator [ Time Frame: up to 6 months and 1 year ]Proportion of patients alive and without progression (RECIST 1.1) within 6 months and 1 year according to the investigator (Progression defined as clinical and/or radiological progression).
- Best response [ Time Frame: up to 1 year ]Best response to study treatment (RECIST 1.1 criteria)
- Curative resectability [ Time Frame: up to 1 year ]Curative resectability
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02384759
|Contact: Lila GABA||+33 3 80 39 34 email@example.com|
|Principal Investigator:||Jean Louis LEGOUX, MD||ORLEANS - Centre Hospitalier La Source|