Pancreatic Neoplasms
Conditions
Keywords
Pancreatic Cancer, Neoplasms Pancreatic, Pancreas Cancer, Pancreas Neoplasms, Pancreatic Tumor, Pancreas Tumor, Unresectable, Metastatic, Refractory
Brief summary
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.
Detailed description
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.
Interventions
Sponsors
Aronex Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed