Phase I FOLFOX Combination

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genzyme, a Sanofi Company
• Treatments: Fluorouracil; Leucovorin; Oxaliplatin

Criteria

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