Aroplatin and Gemcitabine in Patients With Advanced Pancreatic Cancer Resistant to Standard Therapies
This trial is active, not recruiting.
|Treatment||aroplatin (liposomal nddp, l-nddp)|
|Phase||phase 1/phase 2|
|Trial size||111 participants|
|Trial identifier||NCT00081549, C-726-02|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||crossover assignment|
Male or female participants at least 18 years old.
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.
|Official title||A Phase I/II Study of Aroplatin and Gemcitabine In Subjects With Unresectable, Locally Advanced And/Or Metastatic Pancreatic Cancer|
|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.|
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