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

University of Texas Southwestern Medical Center14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cancer of the Pancreas

Interventions

PioglitazoneDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

UT Southwestern Medical Center

Dallas, Texas, United States

Outcomes

Primary Outcomes

Change in Serum Adiponectin Level

We will obtain serum levels of adiponectin at baseline and after 8 weeks of treatment with pioglitazone.

Time frame: Baseline and 8 weeks of treatment with pioglitazone

Change in Standard Glucose Tolerance Test

We will perform the area under the oral glucose tolerance test at baseline and after 8 weeks of treatment with pioglitazone.

Time frame: Baseline to 120 minutes post glucose bolus

Glucose to Insulin Ratio

Glucose to insulin ratio will be measured by taking the ratio of fasting level of serum glucose and insulin. We will obtain serum levels of fasting glucose and insulin every four weeks in all patients receiving pioglitazone

Time frame: Every 4 weeks while receiving treatment, up to 8 weeks

Secondary Outcomes

Change in Weight

To describe changes in weight in patients with pancreas cancer receiving pioglitazone.

Time frame: Baseline and every two weeks for 10 weeks, change between baseline and week 10 reported.

Number of Patients With Objective Response

Objective response is the proportion of patients with confirmed complete response (CR) or confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST).

Time frame: 8 weeks of treatment with pioglitazone

Change in Patients' Performance Status by the Eastern Oncology Cooperative Group (ECOG) Scale of Performance Status

The ECOG Scale of Performance Status measures patients' performance status. Possible grades range from 0 to 5, with lower grade indicating a better performance status.

Data from ClinicalTrials.gov

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