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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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Vandetanib
FOLFIRI
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Colon Cancer, Rectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

1

2

3

Arm Description

FOLFIRI + placebo vandetanib

FOLFIRI + low dose vandetanib

FOLFIRI + high dose vandetanib

Outcomes

Primary Outcome Measures

Number of Patients With an Objective Disease Progression Event
Number of patients with objective disease progression or death (by any cause in the absence of objective progression)

Secondary Outcome Measures

Full Information

First Posted
March 28, 2007
Last Updated
August 25, 2016
Sponsor
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00454116
Brief Title
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
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 an Oxaliplatin and Fluoropyrimidine Containing Regimen
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genzyme, a Sanofi Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colon Cancer, Rectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
FOLFIRI + placebo vandetanib
Arm Title
2
Arm Type
Experimental
Arm Description
FOLFIRI + low dose vandetanib
Arm Title
3
Arm Type
Experimental
Arm Description
FOLFIRI + high dose vandetanib
Intervention Type
Drug
Intervention Name(s)
Vandetanib
Other Intervention Name(s)
ZD6474, ZACTIMA™
Intervention Description
once daily oral tablet two doses
Intervention Type
Drug
Intervention Name(s)
FOLFIRI
Intervention Description
Intravenous infusion
Primary Outcome Measure Information:
Title
Number of Patients With an Objective Disease Progression Event
Description
Number of patients with objective disease progression or death (by any cause in the absence of objective progression)
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
Country
United States
Facility Name
Research Site
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Research Site
City
Buenos Aires
Country
Argentina
Facility Name
Research Site
City
Ramos Mejia
Country
Argentina
Facility Name
Research Site
City
Rosario
Country
Argentina
Facility Name
Research Site
City
Santa Fe
Country
Argentina
Facility Name
Research Site
City
Vicente Lopez
Country
Argentina
Facility Name
Research Site
City
Seoul
Country
Korea, Republic of
Facility Name
Research Site
City
Bergen
Country
Norway
Facility Name
Research Site
City
Oslo
Country
Norway
Facility Name
Research Site
City
Stavanger
Country
Norway
Facility Name
Research Site
City
A Coruna
Country
Spain
Facility Name
Research Site
City
Barcelona
Country
Spain
Facility Name
Research Site
City
Jaen
Country
Spain
Facility Name
Research Site
City
Lerida
Country
Spain
Facility Name
Research Site
City
Lleida
Country
Spain
Facility Name
Research site
City
Belfast
State/Province
Northern Ireland
Country
United Kingdom
Facility Name
Research Site
City
Aberdeen
Country
United Kingdom
Facility Name
Research Site
City
Leicester
Country
United Kingdom
Facility Name
Research Site
City
Manchester
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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