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

NCT01838317 | Completed Phase 2 Results DMC

• 1 other identifier: STU 072012-036
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Change in Weight

  Baseline and every two weeks for 10 weeks, change between baseline and week 10 reported.

• Number of Patients With Objective Response

  8 weeks of treatment with pioglitazone

• Change in Patients' Performance Status by the Eastern Oncology Cooperative Group (ECOG) Scale of Performance Status

  Baseline and 8 weeks of treatment with pioglitazone

• Change in Quality of Life by the FACT-Hep Scale

  Baseline and 8 weeks of treatment with pioglitazone

• Change in Pancreatic Intratumor Fat

  Baseline and 8 weeks of treatment with pioglitazone

Study Arms (2)

Pioglitazone & Chemotherapy in Patients without Diabetes

EXPERIMENTAL

Drug: Pioglitazone

Pioglitazone & Chemotherapy in Patients with Diabetes

EXPERIMENTAL

Drug: Pioglitazone

Interventions

Pioglitazone DRUG

Pioglitazone & Chemotherapy in Patients with Diabetes; Pioglitazone & Chemotherapy in Patients without Diabetes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Histologically proven adenocarcinoma of the pancreas
• Radiologically measurable disease
• ECOG functional status 0-2

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Muhammad Shaalan Beg
• Organization: University of Texas Southwestern Medical Center

muhammad.beg@utsouthwestern.edu

214-648-4180

Study Officials

• Muhammad Beg, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: April 16, 2013
• First Posted: April 24, 2013
• Study Start: May 1, 2013
• Primary Completion: September 20, 2017
• Study Completion: September 20, 2017
• Last Updated: March 1, 2021
• Results First Posted: March 1, 2021

Record last verified: 2021-02

Locations

US (1)