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Phase I Irinotecan, 5-Fluorouracil and Leucovorin Combination

Primary Purpose

Metastatic, Colorectal, Adenocarcinoma

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ZD6474 (vandetanib) 100mg
Irinotecan
5-Fluorouracil
Leucovorin
ZD6474 (vandetanib) 300mg
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic focused on measuring ZD6474, Irinotecan, 5-Fluorouracil, Leucovorin, colorectal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ZD6474 (vandetanib) 100mg

ZD6474 (vandetanib) 300mg

Arm Description

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
July 10, 2007
Last Updated
August 24, 2016
Sponsor
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00507091
Brief Title
Phase I Irinotecan, 5-Fluorouracil and Leucovorin Combination
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 Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genzyme, a Sanofi Company

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic, Colorectal, Adenocarcinoma
Keywords
ZD6474, Irinotecan, 5-Fluorouracil, Leucovorin, colorectal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ZD6474 (vandetanib) 100mg
Arm Type
Experimental
Arm Title
ZD6474 (vandetanib) 300mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ZD6474 (vandetanib) 100mg
Other Intervention Name(s)
ZACTIMA™
Intervention Description
once daily oral tablet
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Other Intervention Name(s)
Camptosar®
Intervention Description
intravenous infusion
Intervention Type
Drug
Intervention Name(s)
5-Fluorouracil
Other Intervention Name(s)
5-FU
Intervention Description
intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Intervention Description
intravenous infusion
Intervention Type
Drug
Intervention Name(s)
ZD6474 (vandetanib) 300mg
Other Intervention Name(s)
ZACTIMA™
Intervention Description
once daily oral tablet
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed metastatic colorectal adenocarcinoma Not amenable to surgery or radiation therapy Eligible for first or second line chemotherapy Exclusion Criteria: Brain metastases or spinal compression Last prior chemotherapy discontinued within 4 weeks before start Last dose radiotherapy within 4 weeks of start
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Gent
Country
Belgium
Facility Name
Research Site
City
Belfast
Country
United Kingdom
Facility Name
Research Site
City
Manchester
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19184020
Citation
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.
Results Reference
background
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1426&filename=CSR-D4200C00038.pdf
Description
Related Info
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1426&filename=CSR-D4200C00038.pdf
Description
CSR-D4200C00038.pdf

Learn more about this trial

Phase I Irinotecan, 5-Fluorouracil and Leucovorin Combination

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