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

NCT ID: NCT01838317

Last Updated: 2021-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2017-09-20

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.

Conditions

Cancer of the Pancreas

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pioglitazone & Chemotherapy in Patients without Diabetes

Group Type: EXPERIMENTAL

Pioglitazone

Intervention Type: DRUG

Pioglitazone & Chemotherapy in Patients with Diabetes

Group Type: EXPERIMENTAL

Pioglitazone

Intervention Type: DRUG

Interventions

Pioglitazone

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Beg

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muhammad Beg, MD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

UT Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STU 072012-036

Identifier Type: -

Identifier Source: org_study_id