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

Primary Purpose

Cancer of the Pancreas

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pioglitazone
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer of the Pancreas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • UT Southwestern Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Pioglitazone & Chemotherapy in Patients without Diabetes

Pioglitazone & Chemotherapy in Patients with Diabetes

Arm Description

Outcomes

Primary Outcome Measures

Change in Serum Adiponectin Level
We will obtain serum levels of adiponectin at baseline and after 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.
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

Secondary Outcome Measures

Change in Weight
To describe changes in weight in patients with pancreas cancer receiving pioglitazone.
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).
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.
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
Change in Pancreatic Intratumor Fat
Change in pancreatic intratumor fat will be measured by MRI
Change in Body Fast Distribution
Change in body fast distribution will be measured by MRI
Changes in Serum and MRI End Points
Compare changes in serum and MRI end points between pioglitazone

Full Information

First Posted
April 16, 2013
Last Updated
February 9, 2021
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01838317
Brief Title
A Phase II Study of Pioglitazone for Patients With Cancer of the Pancreas
Official Title
A Phase II Study of Pioglitazone for Patients With Cancer of the Pancreas
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
September 20, 2017 (Actual)
Study Completion Date
September 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of the Pancreas

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pioglitazone & Chemotherapy in Patients without Diabetes
Arm Type
Experimental
Arm Title
Pioglitazone & Chemotherapy in Patients with Diabetes
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pioglitazone
Primary Outcome Measure Information:
Title
Change in Serum Adiponectin Level
Description
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
Title
Change in Standard Glucose Tolerance Test
Description
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
Title
Glucose to Insulin Ratio
Description
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 Outcome Measure Information:
Title
Change in Weight
Description
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.
Title
Number of Patients With Objective Response
Description
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
Title
Change in Patients' Performance Status by the Eastern Oncology Cooperative Group (ECOG) Scale of Performance Status
Description
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.
Time Frame
Baseline and 8 weeks of treatment with pioglitazone
Title
Change in Quality of Life by the FACT-Hep Scale
Description
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
Time Frame
Baseline and 8 weeks of treatment with pioglitazone
Title
Change in Pancreatic Intratumor Fat
Description
Change in pancreatic intratumor fat will be measured by MRI
Time Frame
Baseline and 8 weeks of treatment with pioglitazone
Title
Change in Body Fast Distribution
Description
Change in body fast distribution will be measured by MRI
Time Frame
Baseline and 8 weeks of treatment with pioglitazone
Title
Changes in Serum and MRI End Points
Description
Compare changes in serum and MRI end points between pioglitazone
Time Frame
Baseline and 8 weeks of treatment with pioglitazone

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Beg, MD
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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