Phase I FOLFOX Combination

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: July 10, 2007
Last updated: April 3, 2009
Last verified: April 2009
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 AstraZeneca:

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
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
Principal Investigator: Michael Michael, MD AstraZeneca
Study Director: Peter Langmuir, MD AstraZeneca
  More Information Identifier: NCT00499850     History of Changes
Other Study ID Numbers: D4200C00037 
Study First Received: July 10, 2007
Last Updated: April 3, 2009
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 26, 2016