Status:
UNKNOWN
Aroplatin and Gemcitabine in Patients With Advanced Pancreatic Cancer Resistant to Standard Therapies
Lead Sponsor:
Aronex Pharmaceuticals
Conditions:
Pancreatic Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 w...
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 metastat...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT00081549
Last Update
June 24 2005
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.