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

The University of Texas System (UT)

Status and phase

Completed

Phase 2

Conditions

Cancer of the Pancreas

Treatments

Drug: Pioglitazone

Study type

Interventional

Funder types

Other

Identifiers

NCT01838317

STU 072012-036

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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