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Completed

NCT Number: NCT00507091

Phase I Irinotecan, 5-Fluorouracil and Leucovorin Combination

A Phase I open label study to asses the safety and tolerability of ZD6474 in combination with Irinotecan, 5-Fluorouracil and Leucovorin (FOLFIRI) as first or second line therapy in patients with metastatic colorectal adenocarcinoma.

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Key information

Conditions

Metastatic Adenocarcinoma Carcinoma Colorectal Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Ghent, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Confirmed metastatic colorectal adenocarcinoma
  • Not amenable to surgery or radiation therapy
  • Eligible for first or second line chemotherapy

Exclusion criteria

  • Brain metastases or spinal compression
  • Last prior chemotherapy discontinued within 4 weeks before start
  • Last dose radiotherapy within 4 weeks of start

Treatment and study plan

ZD6474 (vandetanib) 100mg

Drug

once daily oral tablet

Other names: ZACTIMA™

Irinotecan

Drug

intravenous infusion

Other names: Camptosar®

5-fluorouracil

Drug

intravenous infusion

Other names: 5-FU

Leucovorin

Drug

intravenous infusion

ZD6474 (vandetanib) 300mg

Drug

once daily oral tablet

Other names: ZACTIMA™

Primary outcomes

  1. Establish the safety & efficacy of ZD6474 w/5-fluorouracil,leucovorin & oxaliplatin to patients with advanced colorectal adenocarcinoma, by assessment of AEs, vital signs, clinical chemistry, hematology, urinalysis, ECG and physical examinations

    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 Asses the Safety and Tolerability of ZD6474 (Vandetanib)in Combination With Irinotecan, 5-Fluorouracil and Leucovorin (FOLFIRI) as First or Second Line Therapy in Patients With Metastatic Colorectal Adenocarcinoma.

Important dates

Study start
2005
Primary completion
2006
Study completion
2008
First posted
Jul 25, 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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