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A Phase II, Double Blind Study of 2 Doses of ZACTIMA™(ZD6474) in Combination With FOLFIRI vs FOLFIRI Alone for the Treatment of Colorectal Cancer in Patients

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ClinicalTrials.gov Identifier: NCT00454116
Recruitment Status : Completed
First Posted : March 30, 2007
Results First Posted : May 24, 2011
Last Update Posted : October 7, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to assess the efficacy and safety of 2 doses of ZACTIMA™ (ZD6474) in combination with FOLFIRI vs FOLFIRI alone for the treatment of colorectal cancer in patients who have failed therapy with an oxaliplatin and fluoropyrimidine containing regimen.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Vandetanib Drug: FOLFIRI Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 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, Randomised Study to Assess the Efficacy and Safety of 2 Doses of ZACTIMA™(ZD6474) in Combination With FOLFIRI vs FOLFIRI Alone for the Treatment of Colorectal Cancer in Patients Who Have Failed Therapy With an Oxaliplatin and Fluoropyrimidine Containing Regimen
Study Start Date : March 2007
Primary Completion Date : March 2008
Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Vandetanib
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: 1
FOLFIRI + placebo vandetanib
Drug: FOLFIRI
Intravenous infusion
Experimental: 2
FOLFIRI + low dose vandetanib
Drug: Vandetanib
once daily oral tablet two doses
Other Names:
  • ZD6474
  • ZACTIMA™
Drug: FOLFIRI
Intravenous infusion
Experimental: 3
FOLFIRI + high dose vandetanib
Drug: Vandetanib
once daily oral tablet two doses
Other Names:
  • ZD6474
  • ZACTIMA™
Drug: FOLFIRI
Intravenous infusion


Outcome Measures

Primary Outcome Measures :
  1. Number of Patients With an Objective Disease Progression Event [ Time Frame: 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 (28 March 2008 +/-3 days) ]
    Number of patients with objective disease progression or death (by any cause in the absence of objective progression)


Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Histologically confirmed colorectal cancer
  • Have failed therapy with an oxaliplatin and fluoropyrimidine containing regimen defined as:
  • Progression on or following treatment for metastatic colorectal cancer
  • Progression within 12 months of adjuvant chemotherapy for colorectal cancer

Exclusion Criteria:

  • Previous treatment with small molecule tyrosine kinase inhibitors of VEGFR or EGFR eg, erlotinib, gefitinib. Prior monoclonal antibodies are permitted, eg, cetuximab, bevacizumab.
  • Previous adjuvant therapy with irinotecan within 12 months of randomization
  • More than one prior course of chemotherapy for treatment of metastatic colorectal cancer.
Contacts and Locations

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): NCT00454116


Locations
United States, Michigan
Research Site
Ann Arbor, Michigan, United States
United States, New York
Research Site
New York, New York, United States
United States, Tennessee
Research Site
Nashville, Tennessee, United States
United States, Utah
Research Site
Salt Lake City, Utah, United States
Argentina
Research Site
Buenos Aires, Argentina
Research Site
Ramos Mejia, Argentina
Research Site
Rosario, Argentina
Research Site
Santa Fe, Argentina
Research Site
Vicente Lopez, Argentina
Korea, Republic of
Research Site
Seoul, Korea, Republic of
Norway
Research Site
Bergen, Norway
Research Site
Oslo, Norway
Research Site
Stavanger, Norway
Spain
Research Site
A Coruna, Spain
Research Site
Barcelona, Spain
Research Site
Jaen, Spain
Research Site
Lerida, Spain
Research Site
Lleida, Spain
United Kingdom
Research site
Belfast, Northern Ireland, United Kingdom
Research Site
Aberdeen, United Kingdom
Research Site
Leicester, United Kingdom
Research Site
Manchester, United Kingdom
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Clinical Sciences & Operations Sanofi
More Information

Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00454116     History of Changes
Other Study ID Numbers: D4200C00048
2006-005023-42 ( EudraCT Number )
First Posted: March 30, 2007    Key Record Dates
Results First Posted: May 24, 2011
Last Update Posted: October 7, 2016
Last Verified: August 2016

Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):
Colon Cancer
Rectal Cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases