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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aronex Pharmaceuticals
• Treatments: bis-neodecanoato-1,2-diaminocyclohexaneplatinum(II); Gemcitabine

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.