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

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 Overview

• Status: Completed
• Conditions: Cancer of the Pancreas
• Intervention / Treatment: Drug: Pioglitazone

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • UT southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pioglitazone & Chemotherapy in Patients without Diabetes	Drug: Pioglitazone
Experimental: Pioglitazone & Chemotherapy in Patients with Diabetes	Drug: Pioglitazone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Serum Adiponectin Level	We will obtain serum levels of adiponectin at baseline and after 8 weeks of treatment with pioglitazone.	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.	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	Every 4 weeks while receiving treatment, up to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Weight	To describe changes in weight in patients with pancreas cancer receiving pioglitazone.	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).	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.	Baseline and 8 weeks of treatment with pioglitazone
Change in Quality of Life by the FACT-Hep Scale	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	Baseline and 8 weeks of treatment with pioglitazone
Change in Pancreatic Intratumor Fat	Change in pancreatic intratumor fat will be measured by MRI	Baseline and 8 weeks of treatment with pioglitazone
Change in Body Fast Distribution	Change in body fast distribution will be measured by MRI	Baseline and 8 weeks of treatment with pioglitazone
Changes in Serum and MRI End Points	Compare changes in serum and MRI end points between pioglitazone	Baseline and 8 weeks of treatment with pioglitazone

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Muhammad Beg, MD, UT southwestern Medical Center

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): September 20, 2017
• Study Completion (Actual): September 20, 2017

Study Registration Dates

• First Submitted: April 16, 2013
• First Submitted That Met QC Criteria: April 18, 2013
• First Posted (Estimate): April 24, 2013

Study Record Updates

• Last Update Posted (Actual): March 1, 2021
• Last Update Submitted That Met QC Criteria: February 9, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Hypoglycemic Agents; Physiological Effects of Drugs; Pioglitazone
• Other Study ID Numbers: STU 072012-036