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Brief Title: A Phase II Study of CP-4055 as Second Line Therapy in Patients With Advanced Colorectal Cancer
Official Title: A Phase II Study of CP-4055 as Second Line Therapy in Patients With Advanced Colorectal Cancer
Study ID: NCT00498407
Brief Summary: Patients with histologically or cytologically confirmed metastatic colorectal cancer (CRC) who have failed a first-line chemotherapeutic regimen containing oxaliplatin and 5-fluorouracil (5-FU) with or without bevacizumab, with or without other Investigational Medicinal Products (IMPs), will receive CP-4055 200 mg/m2/day intravenously (IV) on Day 1-5 every four weeks until complete response or disease worsening/progressing.
Detailed Description: This is a multicentre clinical study conducted in the United Kingdom. It is an open label study designed to investigate objective response rate (RR), the time to progression (TTP) and the duration of tumor response in patients with colorectal cancer when treated with CP-4055. The quantitative and qualitative toxicities of the treatment will also be assessed.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Aberdeen Royal Infirmary, Foresterhill,, Aberdeen, , United Kingdom
The Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Medical Oncology Dept. of Cancer Studies and Molecular Medicine, Leicester Royal Infirmary, Leicester, , United Kingdom
Macmillan Lead Clinician in Gastro-intestinal Cancer Mount Vernon Cancer Centre, Northwood, , United Kingdom
Name: Jim Cassidy, MBChB, MD
Affiliation: The Beatson West of Scotland Cancer Centre
Role: PRINCIPAL_INVESTIGATOR