Clinical trial NCT00498407: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Colorectal Cancer
Colorectal Cancer
Keywords: CP-4055
ELACYT(TM)
Cancer
Colorectal cancer
CRC
Second line therapy
Lead sponsor: Clavis Pharma
Sponsor class: INDUSTRY
First posted: 2007-07-10
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: • Objective response rate (RR)
timeFrame: October 2008
Secondary outcomes:
measure: • Time to progression (TTP)
timeFrame: October 2008
measure: • Duration of tumor response
timeFrame: October 2008
measure: • Characterize the quantitative and the qualitative toxicities of the CP-4055 treatment in this patient population
timeFrame: October 2008
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary, Foresterhill,
city: Glasgow
country: United Kingdom
facility: The Beatson West of Scotland Cancer Centre
city: Leicester
country: United Kingdom
facility: Medical Oncology Dept. of Cancer Studies and Molecular Medicine, Leicester Royal Infirmary
city: Northwood
country: United Kingdom
facility: Macmillan Lead Clinician in Gastro-intestinal Cancer Mount Vernon Cancer Centre
Study officials:
affiliation: The Beatson West of Scotland Cancer Centre
name: Jim Cassidy, MBChB, MD
role: PRINCIPAL_INVESTIGATOR
References: