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Completed

NCT Number: NCT00499850

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.

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Key information

Conditions

Advanced Colorectal Carcinoma Adenocarcinoma Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, East Melbourne, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ZD6474 (Vandetanib)

Drug

once daily oral dose

Other names: ZACTIMA™

5-fluorouracil

Drug

intravenous infusion

Other names: 5-FU

Leucovorin

Drug

intravenous infusion

Oxaliplatin

Drug

intravenous infusion

Primary outcomes

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

    Time frame: Assessed at each visit

Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Registry information

Official study 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.

Important dates

Study start
2005
Primary completion
2006
Study completion
2008
First posted
Jul 12, 2007
Registry last updated
Aug 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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