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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Advanced Colorectal Cancer, Colorectal Cancer

Intervention / Treatment
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* Drug: CP-4055


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Objective response rate (RR) |  | October 2008 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Time to progression (TTP) |  | October 2008 | 
| • Duration of tumor response |  | October 2008 | 
| • Characterize the quantitative and the qualitative toxicities of the CP-4055 treatment in this patient population |  | October 2008 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CP-4055, ELACYT(TM), Cancer, Colorectal cancer, CRC, Second line therapy