A Phase II Study of CP-4126 in Patients With Advanced Pancreatic Cancer.
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