Phase I FOLFOX Combination

Phase 1

Completed

• Conditions: Advanced Colorectal Carcinoma

• Registration Number: NCT00499850
• Lead Sponsor: Genzyme, a Sanofi Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Primary Completion: 2006-06
• Study First Submitted: 2007-07-10
• Study First Submitted QC: 2007-07-11
• Study First Posted: 2007-07-12
• Study Completion: 2008-04
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-24
• Last Update Posted: 2016-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of ZD6474 in combination with 5-Fluorouracil, Leucovorin and Oxaliplatin	Assessed at each visit

Trial Locations

Locations (1)

Research Site; 🇦🇺 Parkville, Australia