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

This study has been completed.
Sponsor:
Information provided by:
Clavis Pharma
ClinicalTrials.gov Identifier:
NCT00498407
First received: July 9, 2007
Last updated: June 3, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Advanced Colorectal Cancer
Colorectal Cancer
Drug: CP-4055
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of CP-4055 as Second Line Therapy in Patients With Advanced Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Clavis Pharma:

Primary Outcome Measures:
  • • Objective response rate (RR) [ Time Frame: October 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • • Time to progression (TTP) [ Time Frame: October 2008 ] [ Designated as safety issue: No ]
  • • Duration of tumor response [ Time Frame: October 2008 ] [ Designated as safety issue: No ]
  • • Characterize the quantitative and the qualitative toxicities of the CP-4055 treatment in this patient population [ Time Frame: October 2008 ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: May 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: CP-4055
    CP-4055 5 mg/mL for infusion, dose: 200 mg/m2/day, schedule: d1-5 q4, 30 minutes IV infusion
    Other Names:
    • ELACYT (TM)
    • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00498407

Locations
United Kingdom
Aberdeen Royal Infirmary, Foresterhill,
Aberdeen, United Kingdom, AB25 2ZN
The Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN
Medical Oncology Dept. of Cancer Studies and Molecular Medicine, Leicester Royal Infirmary
Leicester, United Kingdom, LEI 5WW
Macmillan Lead Clinician in Gastro-intestinal Cancer Mount Vernon Cancer Centre
Northwood, United Kingdom, HA6 2RN
Sponsors and Collaborators
Clavis Pharma
Investigators
Principal Investigator: Jim Cassidy, MBChB, MD The Beatson West of Scotland Cancer Centre
  More Information

No publications provided

Responsible Party: Jean-Michel Gaullier, Clavis Pharma
ClinicalTrials.gov Identifier: NCT00498407     History of Changes
Other Study ID Numbers: CP4055-202, Grantor: CDER, IND/IDE Number: NA
Study First Received: July 9, 2007
Last Updated: June 3, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Clavis Pharma:
CP-4055
ELACYT(TM)
Cancer
Colorectal cancer
CRC
Second line therapy

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 23, 2014