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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00498407
• Other study ID #: CP4055-202
• Secondary ID: Grantor: CDERIND
• Status: Completed
• Phase: Phase 2
• First received: July 9, 2007
• Last updated: June 3, 2009
• Start date: May 2007
• Est. completion date: December 2008

Study information

• Verified date: January 2009
• Source: Clavis Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Colorectal Cancer
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• CP-4055
CP-4055 5 mg/mL for infusion, dose: 200 mg/m2/day, schedule: d1-5 q4, 30 minutes IV infusion

Locations

Country	Name	City	State
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
Clavis Pharma

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• Objective response rate (RR)		October 2008	No
Secondary	• Time to progression (TTP)		October 2008	No
Secondary	• Duration of tumor response		October 2008	No
Secondary	• Characterize the quantitative and the qualitative toxicities of the CP-4055 treatment in this patient population		October 2008	Yes