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

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00500292

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 II

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Irinotecan Irinotecan hydrochloride Fluorouracil Oxaliplatin Vandetanib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

The primary objective is to assess the efficacy of ZD6474 in combination with FOLFOX vs FOLFOX alone for the treatment of patients w/colorectal cancer that have failed prior treatment w/irinotecan & fluoropyrimidine [ Time Frame: by assessment of disease progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary objectives are to assess the safety and tolerability of ZD6474 in combination with FOLFOX in the treatment of colorectal cancer by review of AEs and lab parameters. [ Time Frame: assessed at each visit ] [ Designated as safety issue: No ]

Enrollment:	103
Study Start Date:	March 2007
Estimated Study Completion Date:	October 2008

Arms	Assigned Interventions
1: Placebo Comparator FOLFOX + Placebo vandetanib	Drug: FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid intravenous infusion
2: Experimental FOLFOX + low dose vandetanib	Drug: Vandetanib once daily oral tablet two dose strengths Drug: FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid intravenous infusion
3: Experimental FOLFOX + high dose vandetanib	Drug: Vandetanib once daily oral tablet two dose strengths 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00500292

Locations

France
Research Site
Lille Cedex, France
Research Site
Toulouse, 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
Zilina, Slovakia
Research Site
Poprad, Slovakia
Research Site
Trnava, Slovakia
Spain, Asturias
Research Site
Oviedo, Asturias, Spain
Spain, Cantabria
Research Site
Santander, Cantabria, Spain
Spain, Cataluna
Research Site
Hospitalet Dellobregat, Cataluna, 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

AstraZeneca Clinical Trial Information - Outside US This link exits the ClinicalTrials.gov site

Study ID Numbers:	D4200C00047
Study First Received:	July 3, 2007
Last Updated:	June 12, 2008
ClinicalTrials.gov Identifier:	NCT00500292
Health Authority:	France: Afssaps - French Health Products Safety Agency; 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

Study placed in the following topic categories:

Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Irinotecan
Leucovorin
Intestinal Diseases
Rectal Diseases

Intestinal Neoplasms
Oxaliplatin
Digestive System Diseases
Fluorouracil
Gastrointestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs

Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Vitamins
Micronutrients

ClinicalTrials.gov processed this record on January 14, 2009