Advanced Adenocarcinoma of Pancreas Clinical Trial
Official title:
A Phase II Study of CP-4126 in Patients With Advanced Pancreatic Cancer.
The main objective of this study is to assess the biological activity of CP-4126 in patients with advanced pancreatic cancer. In addition, the correlation between hENT1 (human equilibrative nucleoside transporter 1) and overall survival will be studied.
| Status | Completed |
| Enrollment | 21 |
| Est. completion date | September 2011 |
| Est. primary completion date | June 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Histological or cytological confirmed advanced pancreatic cancer* - Not eligible for curative resection - Performance Status (ECOG) 0-2 - Estimated life expectancy of at least 12 weeks - Age = 18 years - Adequate haematological and biological functions: - Neutrophils = 1.5 x 109/L - Platelets > 100.0 x 109/L - Hb = 10 g/dL - AST/ALT and alkaline phosphatase (ALP) = 2.5 x institutional upper limit of normal (ULN), if liver metastases - AST/ALT = 5 x institutional ULN and ALP = 4 x institutional ULN - Bilirubin = 1.5 times institutional ULN, if liver metastases = 3 x institutional ULN - Serum creatinine = 1.5 times institutional ULN - Signed informed consent Exclusion Criteria: - Prior chemotherapy for metastatic disease - Symptomatic brain metastases - Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study - Requirement of concomitant treatment with a non-permitted medication, including high doses of vitamins and alternative drugs - History of allergic reactions to gemcitabine or egg - Presence of any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled inter-current illness including ongoing or active infection) - Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient's compliance - Pregnant or breastfeeding women - Absence of adequate contraception for both male and female fertile patients for the duration of the study; and also for three months after last treatment - Known positive status for HIV - Any reason why, in the investigator's opinion, the patient should not participate in the study. - Drug or alcohol abuse - Prior radical resection, but exploratory laparotomy as well palliative (e.g bypass) surgery are allowed |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Clinique d'Oncologie Médicale, Institut Jules Bordet | Brussels | |
| Norway | Oslo University Hospital, The Norwegian Radium Hospital, | Oslo | |
| Norway | Oslo University Hospital, Ullevål | Oslo |
| Lead Sponsor | Collaborator |
|---|---|
| Clavis Pharma |
Belgium, Norway,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Biological activity of CP-4126 in patients with advanced pancreatic cancer. | Every second cycle | No | |
| Secondary | Overall survival, Objective response rate. | Every second cycle - study length | No |