A Phase II Study of CP-4055 as Second Line Therapy in Patients With Advanced Colorectal Cancer

June 3, 2009 updated by: Clavis Pharma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: CP-4055

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.

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United Kingdom
- - Aberdeen, United Kingdom, AB25 2ZN
    - Aberdeen Royal Infirmary, Foresterhill,
  - Glasgow, United Kingdom, G12 0YN
    - The Beatson West of Scotland Cancer Centre
  - Leicester, United Kingdom, LEI 5WW
    - Medical Oncology Dept. of Cancer Studies and Molecular Medicine, Leicester Royal Infirmary
  - Northwood, United Kingdom, HA6 2RN
    - Macmillan Lead Clinician in Gastro-intestinal Cancer Mount Vernon Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients with histologically or cytologically confirmed metastatic 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)
Measurable disease according to Response Criteria In Solid Tumours (RECIST)
Performance Status 0 - 2 according to ECOG (Eastern Cooperative Oncology Group) Performance Status
Age 18 years or more
Life expectancy > 3 months
Signed informed consent (IC)
Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must have a negative serum or urine pregnancy test within 2 weeks prior to CP-4055 treatment. Nursing patients are excluded.
Male and female patients must use acceptable contraceptive methods for the duration of time on study, and males also for 3 months after the last CP-4055 dose
Adequate haematological and biological functions

Exclusion Criteria:

Known brain metastases
Radiotherapy to more than 30 % of bone marrow
Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
Concomitant treatment with a non-permitted medication:
- Alternative drugs
- High doses of vitamins
History of allergic reactions to ara-C or egg
Any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled inter-current illness including ongoing or active infection)
Any significant central nervous system or psychiatric disorder(s) that would hamper the patient's compliance
Pregnancy, breastfeeding or absence of adequate contraception for both male and female fertile patients
Known positive status for HIV and/or hepatitis B or C
Drug and/or alcohol abuse
Any reason why, in the investigator's opinion, the patient should not participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
• Objective response rate (RR) Time Frame: October 2008	October 2008

Secondary Outcome Measures

Outcome Measure	Time Frame
• Time to progression (TTP) Time Frame: October 2008	October 2008
• Duration of tumor response Time Frame: October 2008	October 2008
• Characterize the quantitative and the qualitative toxicities of the CP-4055 treatment in this patient population Time Frame: October 2008	October 2008

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clavis Pharma

Investigators

Principal Investigator: Jim Cassidy, MBChB, MD, The Beatson West of Scotland Cancer Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

July 9, 2007

First Submitted That Met QC Criteria