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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00500292
First received: July 3, 2007
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Colorectal
Cancer
Drug: Vandetanib
Drug: FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid
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, 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

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


Enrollment: 109
Study Start Date: March 2007
Estimated Study Completion Date: March 2015
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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™
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™
Drug: FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid
intravenous infusion

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT00500292

Locations
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(Barcelo, Spain
Research Site
Oviedo, Spain
Research Site
Santander, Spain
Taiwan
Research Site
Taipei, Taiwan
Research Site
Tao-Yuan, Taiwan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Gill Pover, MD AstraZeneca
Study Director: Peter Langmuir, MD AstraZeneca
  More Information

Additional Information:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00500292     History of Changes
Other Study ID Numbers: D4200C00047
Study First Received: July 3, 2007
Results First Received: April 27, 2011
Last Updated: July 15, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Hungary: National Institute of Pharmacy
South Korea: Korea Food and Drug Administration (KFDA)
Slovakia: State Institute for Drug Control
Spain: Spanish Agency of Medicines
Taiwan: Department of Health

Keywords provided by AstraZeneca:
colorectal
cancer
zactima

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
Fluorouracil
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014