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A Phase II Study of 2 Doses of ZD6474 (Vandetanib) in Combination With FOLFOX vs FOLFOX Alone for the Treatment of Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00500292
Recruitment Status : Completed
First Posted : July 12, 2007
Results First Posted : May 24, 2011
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Study Description
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Brief Summary:
The purpose of this study is to determine whether treatment with ZACTIMA (vandetanib) in combination with FOLFOX is more effective than FOLFOX alone for colorectal cancer in patients who have failed therapy with an irinotecan and fluoropyrimidine containing regimen.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Vandetanib Drug: FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Double-blind, Placebo Controlled, Randomized Study to Assess the Efficacy and Safety of 2 Doses of ZD6474 (Vandetanib) in Combination With FOLFOX vs FOLFOX Alone for the Treatment of Colorectal Cancer in Patients Who Have Failed Therapy With an Irinotecan and Fluoropyrimidine Regimen
Study Start Date : March 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Vandetanib

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: 1
FOLFOX + Placebo vandetanib
 Drug: FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid
intravenous infusion
Experimental: 2
FOLFOX + low dose vandetanib
 Drug: Vandetanib
once daily oral tablet two dose strengths
Other Names:
  • AZ6474
  • ZACTIMA™
  • SAR390530

Drug: FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid
intravenous infusion
Experimental: 3
FOLFOX + high dose vandetanib
 Drug: Vandetanib
once daily oral tablet two dose strengths
Other Names:
  • AZ6474
  • ZACTIMA™
  • SAR390530

Drug: FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid
intravenous infusion


Outcome Measures
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Primary Outcome Measures :
  1. Number of Patients With an Objective Disease Progression Event [ Time Frame: RECIST tumour assessments carried out at screening and then as per site clinical practice until objective progression. The only additional mandatory tumour assessment visit is at the point of data cut-off (5 March 2008 +/-3 days) ]
    Number of patients with objective disease progression or death (by any cause in the absence of objective progression)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Progression on or following treatment for metastatic colorectal cancer
  • Have failed therapy with an irinotecan and fluoropyrimidine containing regimen
  • Have World Health Organisation (WHO) performance status 0-2 and life expectancy >12 weeks

Exclusion Criteria:

  • Previous treatment with small molecule tyrosine kinase inhibitors of VEGFR or EGFR Prior monoclonal antibodies are permitted, (eg, cetuximab, bevacizumab)
  • Previous adjuvant therapy with irinotecan within 12 months of randomisation
  • More than one prior course of chemotherapy for treatment of metastatic colorectal cancer
Contacts and Locations
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Information from the National Library of Medicine

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): NCT00500292


Locations
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France
Research Site
Lille Cedex, France
Research Site
Toulouse Cedex 9, France
Hungary
Research Site
Budapest, Hungary
Research Site
Debrecen, Hungary
Research Site
Szeged, Hungary
Korea, Republic of
Research Site
Seoul, Korea, Republic of
Slovakia
Research Site
Bratislava, Slovakia
Research Site
Poprad, Slovakia
Research Site
Trnava, Slovakia
Research Site
Zilina, Slovakia
Spain
Research Site
Hospitalet deLlobregat, Spain
Research Site
Oviedo, Spain
Research Site
Santander, Spain
Taiwan
Research Site
Taipei, Taiwan
Research Site
Tao-Yuan, Taiwan
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
More Information
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Additional Information:

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Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00500292    
Other Study ID Numbers: D4200C00047
2006-005022-23 ( EudraCT Number )
LPS15025 ( Other Identifier: Sanofi )
First Posted: July 12, 2007    Key Record Dates
Results First Posted: May 24, 2011
Last Update Posted: January 25, 2018
Last Verified: January 2018
Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):
colorectal
cancer
zactima
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Leucovorin
Folic Acid
Fluorouracil
Oxaliplatin
 Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients
Hematinics