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

Phase 2

Completed

Conditions: Cancer of the Pancreas

Interventions: Drug: Pioglitazone

Registration Number: NCT01838317

Lead Sponsor: University of Texas Southwestern Medical Center

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 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 14

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pioglitazone & Chemotherapy in Patients without Diabetes	Pioglitazone	-
Pioglitazone & Chemotherapy in Patients with Diabetes	Pioglitazone	-

Primary Outcome Measures

Name	Time	Method
Change in Serum Adiponectin Level	Baseline and 8 weeks of treatment with pioglitazone	We will obtain serum levels of adiponectin at baseline and after 8 weeks of treatment with pioglitazone.
Change in Standard Glucose Tolerance Test	Baseline to 120 minutes post glucose bolus	We will perform the area under the oral glucose tolerance test at baseline and after 8 weeks of treatment with pioglitazone.
Glucose to Insulin Ratio	Every 4 weeks while receiving treatment, up to 8 weeks	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

Secondary Outcome Measures

Name	Time	Method
Changes in Serum and MRI End Points	Baseline and 8 weeks of treatment with pioglitazone	Compare changes in serum and MRI end points between pioglitazone
Change in Quality of Life by the FACT-Hep Scale	Baseline and 8 weeks of treatment with pioglitazone	The FACT-Hep Scale (version 4) measures quality of life, It consists of five subscales: (1) physical well-being (PWB); (2) social and family well-being (SFWB); (3) emotional well-being (EWB); (4) functional well-being (FWB); and the hepatobiliary cancer subscale (HepCS). Possible scores range from 0 to 180, with lower scores indicating a better quality of life
Change in Weight	Baseline and every two weeks for 10 weeks, change between baseline and week 10 reported.	To describe changes in weight in patients with pancreas cancer receiving pioglitazone.
Number of Patients With Objective Response	8 weeks of treatment with pioglitazone	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).
Change in Patients' Performance Status by the Eastern Oncology Cooperative Group (ECOG) Scale of Performance Status	Baseline and 8 weeks of treatment with pioglitazone	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.
Change in Body Fast Distribution	Baseline and 8 weeks of treatment with pioglitazone	Change in body fast distribution will be measured by MRI
Change in Pancreatic Intratumor Fat	Baseline and 8 weeks of treatment with pioglitazone	Change in pancreatic intratumor fat will be measured by MRI