Phase I Irinotecan, 5-Fluorouracil and Leucovorin Combination

Genzyme, a Sanofi Company24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Colorectal Adenocarcinoma

Interventions

ZD6474 (vandetanib) 100mgDRUG

once daily oral tablet

IrinotecanDRUG

intravenous infusion

5-FluorouracilDRUG

intravenous infusion

Leucovorin

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (3)

Research Site

Ghent, Belgium

Research Site

Belfast, United Kingdom

Research Site

Manchester, United Kingdom

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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