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Phase I FOLFOX Combination

Primary Purpose

Advanced Colorectal Carcinoma

Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
ZD6474 (vandetanib)
5-Fluorouracil
Leucovorin
Oxaliplatin
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Colorectal Carcinoma focused on measuring ZD6474, FOLFOX, colorectal, adenocarcinoma

Eligibility Criteria

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

Inclusion Criteria:

  1. Histologically confirmed locally advanced, recurrent or metastatic colorectal adenocarcinoma (Stage IV)
  2. WHO performance status 0-1
  3. one or more measurable lesions min 10mm by spiral CT or min 20mm by conventional techniques

Exclusion Criteria:

  1. Brain metastasis or spinal cord compression unless irradiated at least 4 weeks before entry and stable
  2. last dose of prior chemotherapy discontinued at least 4 weeks before start study treatment
  3. prior unanticipated severe reaction to oxaliplatin

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site

Outcomes

Primary Outcome Measures

Safety and tolerability of ZD6474 in combination with 5-Fluorouracil, Leucovorin and Oxaliplatin

Secondary Outcome Measures

Full Information

First Posted
July 10, 2007
Last Updated
August 24, 2016
Sponsor
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00499850
Brief Title
Phase I FOLFOX Combination
Official Title
A Phase I,Open Label Study to Assess the Safety and Tolerability of ZD6474 in Combination With 5-Fluorouracil, Leucovorin and Oxaliplatin (mFOLFOX6) as First and Second Line Therapy in Patients With Advanced Colorectal Adenocarcinoma.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
A Phase I,open label study to assess the safety and tolerability of ZD6474 in combination with 5-Fluorouracil, Leucovorin and Oxaliplatin (mFOLFOX6) as first and second line therapy in patients with advanced colorectal adenocarcinoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Colorectal Carcinoma
Keywords
ZD6474, FOLFOX, colorectal, adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ZD6474 (vandetanib)
Other Intervention Name(s)
ZACTIMA™
Intervention Description
once daily oral dose
Intervention Type
Drug
Intervention Name(s)
5-Fluorouracil
Other Intervention Name(s)
5-FU
Intervention Description
intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Intervention Description
intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
intravenous infusion
Primary Outcome Measure Information:
Title
Safety and tolerability of ZD6474 in combination with 5-Fluorouracil, Leucovorin and Oxaliplatin
Time Frame
Assessed at each visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed locally advanced, recurrent or metastatic colorectal adenocarcinoma (Stage IV) WHO performance status 0-1 one or more measurable lesions min 10mm by spiral CT or min 20mm by conventional techniques Exclusion Criteria: Brain metastasis or spinal cord compression unless irradiated at least 4 weeks before entry and stable last dose of prior chemotherapy discontinued at least 4 weeks before start study treatment prior unanticipated severe reaction to oxaliplatin
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
East Melbourne
Country
Australia
Facility Name
Research Site
City
Footscray
Country
Australia
Facility Name
Research Site
City
Heidelberg
Country
Australia
Facility Name
Research Site
City
Parkville
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

Phase I FOLFOX Combination

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