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NCT00507091 Clinical Trial

Phase I Irinotecan, 5-Fluorouracil and Leucovorin Combination

Adenocarcinoma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00507091
Other study ID # D4200C00038
Secondary ID
Status Completed
Phase Phase 1
First received July 10, 2007
Last updated August 24, 2016
Start date August 2005
Est. completion date June 2008

Study information
Verified date August 2016
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Health ServiceBelgium: Ministry of Social Affairs, Public Health and the Environment
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date June 2008
Est. primary completion date May 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ZD6474 (vandetanib) 100mg
once daily oral tablet
• Irinotecan
intravenous infusion
• 5-Fluorouracil
intravenous infusion
• Leucovorin
intravenous infusion
• ZD6474 (vandetanib) 300mg
once daily oral tablet

Locations
Country Name City State
Belgium Research Site Gent
United Kingdom Research Site Belfast
United Kingdom Research Site Manchester

Sponsors (1)
Lead Sponsor Collaborator
Genzyme, a Sanofi Company

Countries where clinical trial is conducted

Belgium,  United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
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