Clinical trial NCT00851084: Study of Aflibercept And Modified FOLFOX6 As First-Line Treatment In Patients With Metastatic Colorectal Cancer
Official title: Randomized, Multinational, Study Of Aflibercept And Modified FOLFOX6 As First-Line Treatment In Patients With Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Neoplasms
Neoplasm Metastasis
Keywords: Angiogenesis
Colon cancer
Rectal cancer
Oxaliplatin
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-02-25
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to estimate the progression-free survival rate at 12 months for the two arms of the study.

Secondary objectives include the evaluation of overall objective response rate to treatment, progression-free survival, overall survival, safety and documentation of potential immunogenicity of aflibercept.

This study was a non-comparative randomized trial and was not powered for a comparison of any of the efficacy endpoints.

Rather, the aim of the trial was to get, for all endpoints, an estimation of the efficacy and safety of aflibercept combined with a modified FOLFOX6 regimen. In such type of non-comparative randomized trial, the control FOLFOLX6 arm was intended to only act as a check on the similarity of the current patients to the historical controls with respect to clinical outcome when given FOLFOX6 treatment.


Eligibility criteria: Inclusion Criteria:

* Histologically proven adenocarcinoma of the colon or the rectum
* Metastatic disease not amenable to potentially curative treatment

Exclusion Criteria:

* Prior therapy for metastatic cancer of the colon or the rectum
* Prior treatment with angiogenesis inhibitors

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Progression Free Survival (PFS) Rate at 12 Months
timeFrame: 12 months
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: From the date of the first randomization until the study data cut-off date, 14 April 2011 (approximately 26 months)
measure: Overall Objective Response Rate (ORR)
timeFrame: From the date of the first randomization until the study data cut-off date, 14 April 2011 (approximately 26 months)
measure: Overall Survival (OS)
timeFrame: From the date of the first randomization until the study data cut-off date, 14 April 2011 (approximately 26 months)
measure: Number of Participants With Treatment-emergent Adverse Events (TEAE)
timeFrame: From the date of the first randomization up to 30 days after the treatment discontinuation or until TEAE was resolved or stabilized
measure: Immunogenicity of Intravenous (IV) Aflibercept
timeFrame: Any time post baseline and 90 days after the last infusion of aflibercept, according to baseline status
Other outcomes:
Locations:
city: Douglas
country: Australia
facility: Sanofi-Aventis Investigational Site Number 036004
city: Hunter Region Mail Centre
country: Australia
facility: Sanofi-Aventis Investigational Site Number 036001
city: Hunter Region Mail Centre
country: Australia
facility: Sanofi-Aventis Investigational Site Number 036003
city: Berlin
country: Germany
facility: Sanofi-Aventis Investigational Site Number 276003
city: Dresden
country: Germany
facility: Sanofi-Aventis Investigational Site Number 276007
city: Hannover
country: Germany
facility: Sanofi-Aventis Investigational Site Number 276001
city: Homberg
country: Germany
facility: Sanofi-Aventis Investigational Site Number 276006
city: Mannheim
country: Germany
facility: Sanofi-Aventis Investigational Site Number 276004
city: Münster
country: Germany
facility: Sanofi-Aventis Investigational Site Number 276002
city: Recklinghausen
country: Germany
facility: Sanofi-Aventis Investigational Site Number 276005
city: Bari
country: Italy
facility: Sanofi-Aventis Investigational Site Number 380005
city: Firenze
country: Italy
facility: Sanofi-Aventis Investigational Site Number 380001
city: Milano
country: Italy
facility: Sanofi-Aventis Investigational Site Number 380002
city: Taormina
country: Italy
facility: Sanofi-Aventis Investigational Site Number 380003
city: Torino
country: Italy
facility: Sanofi-Aventis Investigational Site Number 380004
city: Busan
country: Korea, Republic of
facility: Sanofi-Aventis Investigational Site Number 410003
city: Cheongju
country: Korea, Republic of
facility: Sanofi-Aventis Investigational Site Number 410004
city: Daegu
country: Korea, Republic of
facility: Sanofi-Aventis Investigational Site Number 410005
city: Daejeon
country: Korea, Republic of
facility: Sanofi-Aventis Investigational Site Number 410002
city: Goyang-Si, Gyeonggi-Do
country: Korea, Republic of
facility: Sanofi-Aventis Investigational Site Number 410007
city: Seoul
country: Korea, Republic of
facility: Sanofi-Aventis Investigational Site Number 410006
city: Seoul
country: Korea, Republic of
facility: Sanofi-Aventis Investigational Site Number 410001
city: Ulsan
country: Korea, Republic of
facility: Sanofi-Aventis Investigational Site Number 410008
city: Pyatigorsk
country: Russian Federation
facility: Sanofi-Aventis Investigational Site Number 643002
city: Saint-Petersburg
country: Russian Federation
facility: Sanofi-Aventis Investigational Site Number 643005
city: Sochi
country: Russian Federation
facility: Sanofi-Aventis Investigational Site Number 643001
city: Barcelona
country: Spain
facility: Sanofi-Aventis Investigational Site Number 724005
city: Madrid
country: Spain
facility: Sanofi-Aventis Investigational Site Number 724004
city: Madrid
country: Spain
facility: Sanofi-Aventis Investigational Site Number 724001
city: Sabadell
country: Spain
facility: Sanofi-Aventis Investigational Site Number 724002
city: Santiago De Compostela
country: Spain
facility: Sanofi-Aventis Investigational Site Number 724007
city: Valencia
country: Spain
facility: Sanofi-Aventis Investigational Site Number 724003
city: Leeds
country: United Kingdom
facility: Sanofi-Aventis Investigational Site Number 826004
city: Leicester
country: United Kingdom
facility: Sanofi-Aventis Investigational Site Number 826001
city: Manchester
country: United Kingdom
facility: Sanofi-Aventis Investigational Site Number 826002
city: Slough
country: United Kingdom
facility: Sanofi-Aventis Investigational Site Number 826003
city: Southampton
country: United Kingdom
facility: Sanofi-Aventis Investigational Site Number 826005
Study officials:
affiliation: Peter Mc Callum Cancer Centre, Melbourne, Australia
name: John Zalcberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Folprecht G, Pericay C, Saunders MP, Thomas A, Lopez Lopez R, Roh JK, Chistyakov V, Hohler T, Kim JS, Hofheinz RD, Ackland SP, Swinson D, Kopp M, Udovitsa D, Hall M, Iveson T, Vogel A, Zalcberg JR. Oxaliplatin and 5-FU/folinic acid (modified FOLFOX6) with or without aflibercept in first-line treatment of patients with metastatic colorectal cancer: the AFFIRM study. Ann Oncol. 2016 Jul;27(7):1273-9. doi: 10.1093/annonc/mdw176. Epub 2016 Apr 18.