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Phase I Irinotecan, 5-Fluorouracil and Leucovorin Combination

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Metastatic; Colorectal; Adenocarcinoma

Intervention: ZD6474 (vandetanib) 100mg (Drug); Irinotecan (Drug); 5-Fluorouracil (Drug); Leucovorin (Drug); ZD6474 (vandetanib) 300mg (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Mark Saunders, MD, Principal Investigator, Affiliation: AstraZeneca
Peter Langmuir, Study Director, Affiliation: AstraZeneca


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.

Clinical Details

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

Primary outcome: 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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Research Site, Gent, Belgium

Research Site, Belfast, United Kingdom

Research Site, Manchester, United Kingdom

Additional Information


Related publications:

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.

Starting date: August 2005
Last updated: March 23, 2015

Page last updated: August 23, 2015

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