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Phase I FOLFOX Combination

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00499850
First received: July 10, 2007
Last updated: April 3, 2009
Last verified: April 2009
History of Changes
  Purpose

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:

U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00499850

Locations
Australia
Research Site
East Melbourne, Australia
Research Site
Footscray, Australia
Research Site
Heidelberg, Australia
Research Site
Parkville, Australia
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Michael Michael, MD AstraZeneca
Study Director: Peter Langmuir, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov 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:
ZD6474
FOLFOX
colorectal
adenocarcinoma

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
 Fluorouracil
Oxaliplatin
Leucovorin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on May 16, 2013