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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Colorectal, Cancer

Thank you

Trial Information

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


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

Type of Study:

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

Outcome Measure:

Number of Patients With an Objective Disease Progression Event

Outcome Description:

Number of patients with objective disease progression or death (by any cause in the absence of objective progression)

Outcome 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)

Safety Issue:

No

Principal Investigator

Gill Pover, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

D4200C00047

NCT ID:

NCT00500292

Start Date:

March 2007

Completion Date:

June 2013

Related Keywords:

  • Colorectal
  • Cancer
  • colorectal
  • cancer
  • zactima
  • Colorectal Neoplasms

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