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

Cancer of the Pancreas Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01838317
• Other study ID #: STU 072012-036
• Status: Completed
• Phase: Phase 2
• Start date: May 2013
• Est. completion date: September 20, 2017

Study information

• Verified date: February 2021
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: September 20, 2017
• Est. primary completion date: September 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer of the Pancreas
• Pancreatic Neoplasms

Intervention

Drug:
• Pioglitazone

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in Pancreatic Intratumor Fat	Change in pancreatic intratumor fat will be measured by MRI	Baseline and 8 weeks of treatment with pioglitazone
Secondary	Change in Body Fast Distribution	Change in body fast distribution will be measured by MRI	Baseline and 8 weeks of treatment with pioglitazone
Secondary	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