A Phase II Study of Pioglitazone for Patients With Cancer of the Pancreas
Conditions
Cancer of the Pancreas
Conditions: official terms
Pancreatic Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Pioglitazone
Type: Drug
Overall Status
Recruiting
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 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Signed informed consent

- Histologically proven adenocarcinoma of the pancreas

- Radiologically measurable disease

- ECOG functional status 0-2

Exclusion Criteria:

- 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
Location
UT Southwestern Medical Center
Dallas, Texas, United States
Status: Recruiting
Start Date
May 2013
Completion Date
December 2015
Sponsors
University of Texas Southwestern Medical Center
Source
University of Texas Southwestern Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page