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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pancreatic Neoplasms

Intervention / Treatment
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* Drug: Aroplatin (Liposomal NDDP, L-NDDP)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Aroplatin (Liposomal NDDP, L-NDDP)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic Cancer, Neoplasms Pancreatic, Pancreas Cancer, Pancreas Neoplasms, Pancreatic Tumor, Pancreas Tumor, Unresectable, Metastatic, Refractory