Study of Aflibercept And Modified FOLFOX6 As First-Line Treatment In Patients With Metastatic Colorectal Cancer (AFFIRM)
This study has been completed.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00851084
First received: February 24, 2009
Last updated: March 1, 2012
Last verified: March 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The main objective of the study is to estimate the percentage of patients without progression of the disease at 12 months.
Secondary objectives include the evaluation of response to treatment, overall survival, safety and documentation of potential immunogenicity of aflibercept.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Neoplasms Neoplasm Metastasis |
Drug: aflibercept (AVE0005) Drug: oxaliplatin Drug: 5-FU Drug: Folinic Acid |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized, Multinational, Study Of Aflibercept And Modified FOLFOX6 As First-Line Treatment In Patients With Metastatic Colorectal Cancer |
Resource links provided by NLM:
Drug Information available for:
Folic acid
Leucovorin calcium
Oxaliplatin
Levoleucovorin
Aflibercept
U.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Progression Free Survival rate (PFS) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall Response rate (ORR) [ Time Frame: measured every 8 weeks up to disease progression ] [ Designated as safety issue: No ]
- Progression free survival (PFS) [ Time Frame: Study period ] [ Designated as safety issue: No ]
- Overall Survival (OS) [ Time Frame: Study period ] [ Designated as safety issue: No ]
| Enrollment: | 268 |
| Study Start Date: | February 2009 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A
modified FOLFOX6
|
Drug: oxaliplatin
administration: IV infusion
Drug: 5-FU
administration: IV infusion
Drug: Folinic Acid
administration: IV infusion
|
|
Experimental: B
modified FOLFOX6 in combination with aflibercept
|
Drug: aflibercept (AVE0005)
administration: IV infusion
Drug: oxaliplatin
administration: IV infusion
Drug: 5-FU
administration: IV infusion
Drug: Folinic Acid
administration: IV infusion
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00851084
Hide Study Locations
Hide Study LocationsLocations
| Australia | |
| Sanofi-Aventis Investigational Site Number 036004 | |
| Douglas, Australia, 4814 | |
| Sanofi-Aventis Investigational Site Number 036001 | |
| Hunter Region Mail Centre, Australia, 2310 | |
| Sanofi-Aventis Investigational Site Number 036003 | |
| Hunter Region Mail Centre, Australia, 2310 | |
| Germany | |
| Sanofi-Aventis Investigational Site Number 276003 | |
| Berlin, Germany, 13353 | |
| Sanofi-Aventis Investigational Site Number 276007 | |
| Dresden, Germany, 01307 | |
| Sanofi-Aventis Investigational Site Number 276001 | |
| Hannover, Germany, 30625 | |
| Sanofi-Aventis Investigational Site Number 276006 | |
| Homberg, Germany, 66421 | |
| Sanofi-Aventis Investigational Site Number 276004 | |
| Mannheim, Germany, 68167 | |
| Sanofi-Aventis Investigational Site Number 276002 | |
| Münster, Germany, 48149 | |
| Sanofi-Aventis Investigational Site Number 276005 | |
| Recklinghausen, Germany, 45659 | |
| Italy | |
| Sanofi-Aventis Investigational Site Number 380005 | |
| Bari, Italy, 70126 | |
| Sanofi-Aventis Investigational Site Number 380001 | |
| Firenze, Italy, 50141 | |
| Sanofi-Aventis Investigational Site Number 380002 | |
| Milano, Italy, 20121 | |
| Sanofi-Aventis Investigational Site Number 380003 | |
| Taormina, Italy, 98039 | |
| Sanofi-Aventis Investigational Site Number 380004 | |
| Torino, Italy, 10126 | |
| Korea, Republic of | |
| Sanofi-Aventis Investigational Site Number 410003 | |
| Busan, Korea, Republic of, 614-735 | |
| Sanofi-Aventis Investigational Site Number 410004 | |
| Cheongju, Korea, Republic of, 361-711 | |
| Sanofi-Aventis Investigational Site Number 410005 | |
| Daegu, Korea, Republic of, 700-721 | |
| Sanofi-Aventis Investigational Site Number 410002 | |
| Daejeon, Korea, Republic of | |
| Sanofi-Aventis Investigational Site Number 410007 | |
| Goyang-Si, Gyeonggi-Do, Korea, Republic of, 410-769 | |
| Sanofi-Aventis Investigational Site Number 410006 | |
| Seoul, Korea, Republic of, 120-752 | |
| Sanofi-Aventis Investigational Site Number 410001 | |
| Seoul, Korea, Republic of, 152-703 | |
| Sanofi-Aventis Investigational Site Number 410008 | |
| Ulsan, Korea, Republic of, 682-714 | |
| Russian Federation | |
| Sanofi-Aventis Investigational Site Number 643002 | |
| Pyatigorsk, Russian Federation, 357500 | |
| Sanofi-Aventis Investigational Site Number 643005 | |
| Saint-Petersburg, Russian Federation, 197758 | |
| Sanofi-Aventis Investigational Site Number 643001 | |
| Sochi, Russian Federation, 354057 | |
| Spain | |
| Sanofi-Aventis Investigational Site Number 724005 | |
| Barcelona, Spain, 08036 | |
| Sanofi-Aventis Investigational Site Number 724001 | |
| Madrid, Spain, 28040 | |
| Sanofi-Aventis Investigational Site Number 724004 | |
| Madrid, Spain, 28007 | |
| Sanofi-Aventis Investigational Site Number 724002 | |
| Sabadell, Spain, 08208 | |
| Sanofi-Aventis Investigational Site Number 724007 | |
| Santiago De Compostela, Spain, 15706 | |
| Sanofi-Aventis Investigational Site Number 724003 | |
| Valencia, Spain, 46009 | |
| United Kingdom | |
| Sanofi-Aventis Investigational Site Number 826004 | |
| Leeds, United Kingdom, LS9 7TF | |
| Sanofi-Aventis Investigational Site Number 826001 | |
| Leicester, United Kingdom, LE1 5WW | |
| Sanofi-Aventis Investigational Site Number 826002 | |
| Manchester, United Kingdom, M20 4BX | |
| Sanofi-Aventis Investigational Site Number 826003 | |
| Slough, United Kingdom, SL2 4HL | |
| Sanofi-Aventis Investigational Site Number 826005 | |
| Southampton, United Kingdom, SO16 6YD | |
Sponsors and Collaborators
Sanofi
Investigators
| Principal Investigator: | John Zalcberg, MD | Peter Mc Callum Cancer Centre, Melbourne, Australia |
More Information
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00851084 History of Changes |
| Other Study ID Numbers: | EFC10668, EudraCT 2008-004178-41 |
| Study First Received: | February 24, 2009 |
| Last Updated: | March 1, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Sanofi:
|
Angiogenesis Colon cancer Rectal cancer Oxaliplatin |
Additional relevant MeSH terms:
|
Neoplasms Colorectal Neoplasms Neoplasm Metastasis Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Neoplastic Processes Pathologic Processes Leucovorin |
Folic Acid Levoleucovorin Oxaliplatin Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Antidotes Protective Agents Hematinics Hematologic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 22, 2013