A Phase II Study of Pioglitazone for Patients With Cancer of the Pancreas

Completed · Phase 2

Conditions studied: Cancer of the Pancreas

In brief

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 utilize sugar (glucose and insulin metabolism). In addition the investigators want to determine whether or not treatment with pioglitazone results in (1) improvement in the size of the tumor, (2) weight gain, (3) improved ability to function during the day and (4) quality of life.

Key facts

Study ID: NCT01838317
Run by: University of Texas Southwestern Medical Center
People needed: 14
Starts: 2013-05-01
Expected to finish: 2017-09-20
Last updated by the study team: 2021-03-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Signed informed consent
Histologically proven adenocarcinoma of the pancreas
Radiologically measurable disease
ECOG functional status 0-2

You may not qualify if…

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

Where it is running

UT Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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