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Completed

NCT Number: NCT00498407

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

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.

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Key information

Conditions

Advanced Colorectal Cancer Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Aberdeen Royal Infirmary, Foresterhill,, Aberdeen, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CP-4055

Drug

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

Other names: ELACYT (TM)

Primary outcomes

  1. • Objective response rate (RR)

    Time frame: October 2008

Secondary outcomes

  1. • Time to progression (TTP)

    Time frame: October 2008

  2. • Duration of tumor response

    Time frame: October 2008

  3. • Characterize the quantitative and the qualitative toxicities of the CP-4055 treatment in this patient population

    Time frame: October 2008

Sponsors and collaborators

Lead sponsor

Clavis Pharma

Industry

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 10, 2007
Registry last updated
Jun 4, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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