Phase I FOLFOX Combination

Genzyme, a Sanofi Company18 enrolled

Overview

A Phase I,open label study to assess the safety and tolerability of ZD6474 in combination with 5-Fluorouracil, Leucovorin and Oxaliplatin (mFOLFOX6) as first and second line therapy in patients with advanced colorectal adenocarcinoma.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Colorectal Carcinoma

Interventions

ZD6474 (vandetanib)DRUG

once daily oral dose

5-FluorouracilDRUG

intravenous infusion

LeucovorinDRUG

intravenous infusion

Oxaliplatin

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Histologically confirmed locally advanced, recurrent or metastatic colorectal adenocarcinoma (Stage IV) 2. WHO performance status 0-1 3. one or more measurable lesions min 10mm by spiral CT or min 20mm by conventional techniques Exclusion Criteria: 1. Brain metastasis or spinal cord compression unless irradiated at least 4 weeks before entry and stable 2. last dose of prior chemotherapy discontinued at least 4 weeks before start study treatment 3. prior unanticipated severe reaction to oxaliplatin

Locations (4)

Research Site

East Melbourne, Australia

Research Site

Footscray, Australia

Research Site

Heidelberg, Australia

Research Site

Parkville, Australia

Outcomes

Primary Outcomes

Safety and tolerability of ZD6474 in combination with 5-Fluorouracil, Leucovorin and Oxaliplatin

Time frame: Assessed at each visit

Data from ClinicalTrials.gov

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