Phase I Irinotecan, 5-Fluorouracil and Leucovorin Combination
NCT ID: NCT00507091
Last Updated: 2016-08-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2005-08-31
2008-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ZD6474 (vandetanib) 100mg
ZD6474 (vandetanib) 100mg
once daily oral tablet
Irinotecan
intravenous infusion
5-Fluorouracil
intravenous infusion
Leucovorin
intravenous infusion
ZD6474 (vandetanib) 300mg
Irinotecan
intravenous infusion
5-Fluorouracil
intravenous infusion
Leucovorin
intravenous infusion
ZD6474 (vandetanib) 300mg
once daily oral tablet
Interventions
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ZD6474 (vandetanib) 100mg
once daily oral tablet
Irinotecan
intravenous infusion
5-Fluorouracil
intravenous infusion
Leucovorin
intravenous infusion
ZD6474 (vandetanib) 300mg
once daily oral tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Not amenable to surgery or radiation therapy
3. Eligible for first or second line chemotherapy
Exclusion Criteria
2. Last prior chemotherapy discontinued within 4 weeks before start
3. Last dose radiotherapy within 4 weeks of start
18 Years
ALL
No
Sponsors
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Genzyme, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Research Site
Ghent, , Belgium
Research Site
Belfast, , United Kingdom
Research Site
Manchester, , United Kingdom
Countries
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References
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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.
Related Links
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Other Identifiers
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D4200C00038
Identifier Type: -
Identifier Source: org_study_id
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