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Phase I Irinotecan, 5-Fluorouracil and Leucovorin Combination

Sponsor
Genzyme, a Sanofi Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00507091
Collaborator
(none)
24
Enrollment
3
Locations
2
Arms
34
Duration (Months)
8
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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.
Study Start Date :
Aug 1, 2005
Actual Primary Completion Date :
May 1, 2006
Actual Study Completion Date :
Jun 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: ZD6474 (vandetanib) 100mg

Drug: ZD6474 (vandetanib) 100mg
once daily oral tablet
Other Names:
  • ZACTIMA™

    • Drug: Irinotecan
    intravenous infusion
    Other Names:
  • Camptosar®

    • Drug: 5-Fluorouracil
    intravenous infusion
    Other Names:
  • 5-FU

    • Drug: Leucovorin
    intravenous infusion
    Experimental: ZD6474 (vandetanib) 300mg

    Drug: Irinotecan
    intravenous infusion
    Other Names:
  • Camptosar®

    • Drug: 5-Fluorouracil
    intravenous infusion
    Other Names:
  • 5-FU

    • Drug: Leucovorin
    intravenous infusion

    Drug: ZD6474 (vandetanib) 300mg
    once daily oral tablet
    Other Names:
  • ZACTIMA™

    		•

    Outcome Measures

    Primary Outcome Measures

    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 [assessed at each visit]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Gent Belgium
    2 Research Site Belfast United Kingdom
    3 Research Site Manchester United Kingdom

    Sponsors and Collaborators

    • Genzyme, a Sanofi Company

    Investigators

    • Study Director: Clinical Sciences & Operations, Sanofi

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Genzyme, a Sanofi Company
    ClinicalTrials.gov Identifier:
    NCT00507091
    Other Study ID Numbers:
    • D4200C00038
    First Posted:
    Jul 25, 2007
    Last Update Posted:
    Aug 25, 2016
    Last Verified:
    Aug 1, 2016
    Keywords provided by Genzyme, a Sanofi Company
    ZD6474
    Irinotecan
    5-Fluorouracil
    Leucovorin
    colorectal
    Additional relevant MeSH terms:
    Adenocarcinoma
    Leucovorin
    Fluorouracil
    Irinotecan

    Study Results

    No Results Posted as of Aug 25, 2016