Status:
COMPLETED
A Phase II Study of Pioglitazone for Patients With Cancer of the Pancreas
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Cancer of the Pancreas
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is being done to determine whether or not addition of the oral medication, pioglitazone to standard chemotherapy, results in improvement of blood tests that measure the body's ability to ut...
Eligibility Criteria
Inclusion
- Signed informed consent
- Histologically proven adenocarcinoma of the pancreas
- Radiologically measurable disease
- ECOG functional status 0-2
Exclusion
- Prior radiation therapy for pancreatic cancer If chemotherapy is planned, new chemotherapy regimen should have started more than 14 days prior to enrollment
- Surgery or radiation planned within 8 weeks of starting therapy
- Prior exposure to Thiazolidinedione (TZD) therapy in the past 12 months
- Hypersensitivity of TZD
- New York heart association class III/IV heart failure.
- Known HIV positive
- Pregnant or lactating women
- History of, or active bladder cancer
- Inadequate hepatic function documented within 14 days of enrollment
- Total bilirubin level \> 1.5 x ULN
- AST and ALT \> 2.5 x ULN, unless there are liver metastases in which case AST and ALT or \> 5 x ULN
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2017
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01838317
Start Date
May 1 2013
End Date
September 20 2017
Last Update
March 1 2021
Active Locations (1)
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1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390