A Phase I/II Study of Aroplatin and Gemcitabine In Subjects With Unresectable, Locally Advanced And/Or Metastatic Pancreatic Cancer
Data Collection
Digestive System Diseases+5
+ Digestive System Neoplasms
+ Endocrine System Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.111 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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.