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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00454116
First received: March 28, 2007
Last updated: April 27, 2011
Last verified: April 2011
  Purpose

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 Intervention Phase
Colorectal Cancer
Drug: Vandetanib
Drug: FOLFIRI
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Anoxaliplatin and Fluoropyrimidine Containing Regimen

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    Number of patients with objective disease progression or death (by any cause in the absence of objective progression)


Enrollment: 106
Study Start Date: March 2007
Study Completion Date: November 2009
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
AstraZeneca
Investigators
Study Director: Zactima Medical Science Director, MD AstraZeneca
  More Information

No publications provided

Responsible Party: MSD
ClinicalTrials.gov Identifier: NCT00454116     History of Changes
Other Study ID Numbers: D4200C00048
Study First Received: March 28, 2007
Results First Received: April 27, 2011
Last Updated: April 27, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
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

ClinicalTrials.gov processed this record on September 16, 2014