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Phase I Irinotecan, 5-Fluorouracil and Leucovorin Combination

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00507091
First received: July 10, 2007
Last updated: August 24, 2016
Last verified: August 2016
July 10, 2007
August 24, 2016
August 2005
May 2006   (Final data collection date for primary outcome measure)
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 ]
Establish the safety & efficacy of ZD6474 w/5-fluorouracil,lecovorin & oxaliplatin to patients with advanced colorectal adenocarcinoma, by assessment of AEs, vital signs, clinical chemistry, haematology, urinalysis, ECG and physical examinations
Complete list of historical versions of study NCT00507091 on ClinicalTrials.gov Archive Site
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Phase I Irinotecan, 5-Fluorouracil and Leucovorin Combination
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.
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Metastatic
  • Colorectal
  • Adenocarcinoma
  • Drug: ZD6474 (vandetanib) 100mg
    once daily oral tablet
    Other Name: ZACTIMA™
  • Drug: Irinotecan
    intravenous infusion
    Other Name: Camptosar®
  • Drug: 5-Fluorouracil
    intravenous infusion
    Other Name: 5-FU
  • Drug: Leucovorin
    intravenous infusion
  • Drug: ZD6474 (vandetanib) 300mg
    once daily oral tablet
    Other Name: ZACTIMA™
  • Experimental: ZD6474 (vandetanib) 100mg
    Interventions:
    • Drug: ZD6474 (vandetanib) 100mg
    • Drug: Irinotecan
    • Drug: 5-Fluorouracil
    • Drug: Leucovorin
  • Experimental: ZD6474 (vandetanib) 300mg
    Interventions:
    • Drug: Irinotecan
    • Drug: 5-Fluorouracil
    • Drug: Leucovorin
    • Drug: ZD6474 (vandetanib) 300mg
Saunders MP, Wilson R, Peeters M, Smith R, Godwood A, Oliver S, Van Cutsem E. Vandetanib with FOLFIRI in patients with advanced colorectal adenocarcinoma: results from an open-label, multicentre Phase I study. Cancer Chemother Pharmacol. 2009 Sep;64(4):665-72. doi: 10.1007/s00280-008-0914-4. Epub 2009 Jan 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
June 2008
May 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Confirmed metastatic colorectal adenocarcinoma
  2. Not amenable to surgery or radiation therapy
  3. Eligible for first or second line chemotherapy

Exclusion Criteria:

  1. Brain metastases or spinal compression
  2. Last prior chemotherapy discontinued within 4 weeks before start
  3. Last dose radiotherapy within 4 weeks of start
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   United Kingdom
 
 
NCT00507091
D4200C00038
Not Provided
Not Provided
Not Provided
Sanofi ( Genzyme, a Sanofi Company )
Genzyme, a Sanofi Company
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
August 2016

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