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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

Phase 2
Completed
Conditions
Colorectal Cancer
Interventions
Drug: FOLFIRI
Drug: Vandetanib
Registration Number
NCT00454116
Lead Sponsor
Genzyme, a Sanofi Company
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
106
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
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
1FOLFIRIFOLFIRI + placebo vandetanib
2FOLFIRIFOLFIRI + low dose vandetanib
3FOLFIRIFOLFIRI + high dose vandetanib
2VandetanibFOLFIRI + low dose vandetanib
3VandetanibFOLFIRI + high dose vandetanib
Primary Outcome Measures
NameTimeMethod
Number of Patients With an Objective Disease Progression EventTumour 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)

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

Research Site

🇬🇧

Manchester, United Kingdom

Research site

🇬🇧

Belfast, Northern Ireland, United Kingdom

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