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Phase I Irinotecan, 5-Fluorouracil and Leucovorin Combination

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00507091
First Posted: July 25, 2007
Last Update Posted: August 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
  Purpose
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
Metastatic Colorectal Adenocarcinoma 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: 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.

Resource links provided by NLM:


Further study details as provided by Sanofi ( Genzyme, a Sanofi Company ):

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™

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00507091


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

Additional Information:
Publications:
Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00507091     History of Changes
Other Study ID Numbers: D4200C00038
First Submitted: July 10, 2007
First Posted: July 25, 2007
Last Update Posted: August 25, 2016
Last Verified: August 2016

Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):
ZD6474
Irinotecan
5-Fluorouracil
Leucovorin
colorectal

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Irinotecan
Camptothecin
Fluorouracil
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs