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

July 10, 2007
April 3, 2009
August 2005
June 2006   (final data collection date for primary outcome measure)
Safety and tolerability of ZD6474 in combination with 5-Fluorouracil, Leucovorin and Oxaliplatin [ Time Frame: Assessed at each visit ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00499850 on ClinicalTrials.gov Archive Site
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Phase I FOLFOX Combination
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.

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.

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Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Colorectal Carcinoma
  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
April 2008
June 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00499850
D4200C00037
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AstraZeneca
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Principal Investigator: Michael Michael, MD AstraZeneca
Study Director: Peter Langmuir, MD AstraZeneca
AstraZeneca
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP