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Phase I FOLFOX Combination

This study has been completed.
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company ) Identifier:
First received: July 10, 2007
Last updated: August 24, 2016
Last verified: August 2016
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.

Condition Intervention Phase
Advanced Colorectal Carcinoma
Drug: ZD6474 (vandetanib)
Drug: 5-Fluorouracil
Drug: Leucovorin
Drug: Oxaliplatin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Safety and tolerability of ZD6474 in combination with 5-Fluorouracil, Leucovorin and Oxaliplatin [ Time Frame: Assessed at each visit ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: August 2005
Study Completion Date: April 2008
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: ZD6474 (vandetanib)
    once daily oral dose
    Other Name: ZACTIMA™
    Drug: 5-Fluorouracil
    intravenous infusion
    Other Name: 5-FU
    Drug: Leucovorin
    intravenous infusion
    Drug: Oxaliplatin
    intravenous infusion

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00499850

Research Site
East Melbourne, Australia
Research Site
Footscray, Australia
Research Site
Heidelberg, Australia
Research Site
Parkville, Australia
Sponsors and Collaborators
Genzyme, a Sanofi Company
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Genzyme, a Sanofi Company Identifier: NCT00499850     History of Changes
Other Study ID Numbers: D4200C00037 
Study First Received: July 10, 2007
Last Updated: August 24, 2016
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Sanofi:

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on October 21, 2016