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

Primary Purpose

Advanced Colorectal Cancer, Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
CP-4055
Sponsored by
Clavis Pharma
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Colorectal Cancer focused on measuring CP-4055, ELACYT(TM), Cancer, Colorectal cancer, CRC, Second line therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aberdeen Royal Infirmary, Foresterhill,
  • The Beatson West of Scotland Cancer Centre
  • Medical Oncology Dept. of Cancer Studies and Molecular Medicine, Leicester Royal Infirmary
  • Macmillan Lead Clinician in Gastro-intestinal Cancer Mount Vernon Cancer Centre

Outcomes

Primary Outcome Measures

• Objective response rate (RR)

Secondary Outcome Measures

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

Full Information

First Posted
July 9, 2007
Last Updated
June 3, 2009
Sponsor
Clavis Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00498407
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 Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Clavis Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Colorectal Cancer, Colorectal Cancer
Keywords
CP-4055, ELACYT(TM), Cancer, Colorectal cancer, CRC, Second line therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
CP-4055
Other Intervention Name(s)
ELACYT (TM)
Intervention Description
CP-4055 5 mg/mL for infusion, dose: 200 mg/m2/day, schedule: d1-5 q4, 30 minutes IV infusion
Primary Outcome Measure Information:
Title
• Objective response rate (RR)
Time Frame
October 2008
Secondary Outcome Measure Information:
Title
• Time to progression (TTP)
Time Frame
October 2008
Title
• Duration of tumor response
Time Frame
October 2008
Title
• Characterize the quantitative and the qualitative toxicities of the CP-4055 treatment in this patient population
Time Frame
October 2008

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jim Cassidy, MBChB, MD
Organizational Affiliation
The Beatson West of Scotland Cancer Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aberdeen Royal Infirmary, Foresterhill,
City
Aberdeen
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
The Beatson West of Scotland Cancer Centre
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Medical Oncology Dept. of Cancer Studies and Molecular Medicine, Leicester Royal Infirmary
City
Leicester
ZIP/Postal Code
LEI 5WW
Country
United Kingdom
Facility Name
Macmillan Lead Clinician in Gastro-intestinal Cancer Mount Vernon Cancer Centre
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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