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

A Phase I/II Study of Aroplatin and Gemcitabine In Subjects With Unresectable, Locally Advanced And/Or Metastatic Pancreatic Cancer

This study is a Phase I/II study. In Phase I of this study, the objective is to determine the maximum tolerated dose (MTD) of combination therapy with Aroplatin and gemcitabine (Gemzar®) in subjects with unresectable, locally advanced and/or metastatic pancreatic cancer. In Phase II, the primary objective is to evaluate survival after therapy with Aroplatin and gemcitabine at the identified MTD in subjects with unresectable, locally advanced and/or metastatic pancreatic cancer. Secondary objectives are to evaluate the severity and quantity of adverse events and determine the proportion of non-progressors and the progression-free interval.

Phase I Primary Objective:

• Determine the maximum tolerated dose (MTD) of combination therapy with Aroplatin and gemcitabine (Gemzar®) in subjects with unresectable, locally advanced and/or metastatic pancreatic cancer.

Phase II Primary Objective:

• Evaluate survival after therapy with Aroplatin and gemcitabine at the MTD in subjects with unresectable, locally advanced and/or metastatic pancreatic cancer.

Phase II Secondary Objective:

• Evaluate the severity and quantity of adverse events and determine the proportion of non-progressors and the progression-free interval.

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.