Trial | NCT00498407  Report issue

Official Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    16
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.
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 Started
May 31
2007
Primary Completion
Dec 31
2008
Study Completion
Dec 31
2008
Last Update
Jun 04
2009
Estimate

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)

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
No Results Posted