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Study of Aflibercept And Modified FOLFOX6 As First-Line Treatment In Patients With Metastatic Colorectal Cancer (AFFIRM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00851084
First received: February 24, 2009
Last updated: March 1, 2012
Last verified: March 2012
History of Changes
  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:

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

  Show 37 Study Locations
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 21, 2013