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

Phase 2

Completed

• Conditions: Advanced Colorectal Cancer; Colorectal Cancer

• Registration Number: NCT00498407
• Lead Sponsor: Clavis Pharma

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.

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-07-09
• Study First Submitted QC: 2007-07-09
• Study First Posted: 2007-07-10
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2009-01
• Last Update Submitted: 2009-06-03
• Last Update Posted: 2009-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1. 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)
2. Measurable disease according to Response Criteria In Solid Tumours (RECIST)
3. Performance Status 0 - 2 according to ECOG (Eastern Cooperative Oncology Group) Performance Status
4. Age 18 years or more
5. Life expectancy > 3 months
6. Signed informed consent (IC)
7. 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.
8. 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
9. Adequate haematological and biological functions

Exclusion Criteria

1. Known brain metastases

2. Radiotherapy to more than 30 % of bone marrow

3. Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study

4. Concomitant treatment with a non-permitted medication:

   • Alternative drugs
   • High doses of vitamins

5. History of allergic reactions to ara-C or egg

6. Any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled inter-current illness including ongoing or active infection)

7. Any significant central nervous system or psychiatric disorder(s) that would hamper the patient's compliance

8. Pregnancy, breastfeeding or absence of adequate contraception for both male and female fertile patients

9. Known positive status for HIV and/or hepatitis B or C

10. Drug and/or alcohol abuse

11. Any reason why, in the investigator's opinion, the patient should not participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
• Objective response rate (RR)	October 2008

Secondary Outcome Measures

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

Trial Locations

Locations (4)

The Beatson West of Scotland Cancer Centre; 🇬🇧 Glasgow, United Kingdom

Aberdeen Royal Infirmary, Foresterhill,; 🇬🇧 Aberdeen, 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