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Phase I Irinotecan, 5-Fluorouracil and Leucovorin Combination

This study has been completed.
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company ) Identifier:
First received: July 10, 2007
Last updated: August 24, 2016
Last verified: August 2016
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 Intervention Phase
Drug: ZD6474 (vandetanib) 100mg
Drug: Irinotecan
Drug: 5-Fluorouracil
Drug: Leucovorin
Drug: ZD6474 (vandetanib) 300mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ]

Enrollment: 24
Study Start Date: August 2005
Study Completion Date: June 2008
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ZD6474 (vandetanib) 100mg 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
Experimental: ZD6474 (vandetanib) 300mg 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™


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT00507091

Research Site
Gent, Belgium
United Kingdom
Research Site
Belfast, United Kingdom
Research Site
Manchester, United Kingdom
Sponsors and Collaborators
Genzyme, a Sanofi Company
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Additional Information:
Responsible Party: Genzyme, a Sanofi Company Identifier: NCT00507091     History of Changes
Other Study ID Numbers: D4200C00038
Study First Received: July 10, 2007
Last Updated: August 24, 2016

Keywords provided by Sanofi:

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors processed this record on May 23, 2017