Aroplatin and Gemcitabine in Patients With Advanced Pancreatic Cancer Resistant to Standard Therapies

Inclusion Criteria Pancreatic cancer (AJCC Stage II-IV); Unresectable cancer; Measurable disease (RECIST criteria); No prior therapy; ECOG Score 0-2 Life expectancy greater then or equal to three months; Adequate hematopoietic, liver and renal function; Women of child-bearing potential must have negative urine/serum pregnancy test; Signed written informed consent; Subjects must be willing to be followed during the course of the treatment/observation and follow-up. Exclusion Criteria: Prior therapy for pancreatic cancer; Previously diagnosed brain metastases if symptomatic and requiring active therapy; Other cancers within the last five years, with the exception of adequately treated cone-biopsied in-situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin; Any serious concomitant medical or mental illness requiring intense therapy and interfering with participation in this study Primary or secondary immunodeficiency, or use of corticosteroids immunosuppressive medication; Women must not be pregnant or breast-feeding; Participation in any clinical trial involving investigational drugs within one month from enrollment into the present study.