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Completed

NCT Number: NCT01838317

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.

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Key information

Conditions

Cancer of the Pancreas Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pioglitazone

Drug

Primary outcomes

  1. Change in Serum Adiponectin Level

    Time frame: Baseline and 8 weeks of treatment with pioglitazone

    We will obtain serum levels of adiponectin at baseline and after 8 weeks of treatment with pioglitazone.

  2. Change in Standard Glucose Tolerance Test

    Time frame: Baseline to 120 minutes post glucose bolus

    We will perform the area under the oral glucose tolerance test at baseline and after 8 weeks of treatment with pioglitazone.

  3. Glucose to Insulin Ratio

    Time frame: Every 4 weeks while receiving treatment, up to 8 weeks

    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 outcomes

  1. Change in Weight

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

    To describe changes in weight in patients with pancreas cancer receiving pioglitazone.

  2. Number of Patients With Objective Response

    Time frame: 8 weeks of treatment with pioglitazone

    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).

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

    Time frame: Baseline and 8 weeks of treatment with pioglitazone

    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.

  4. Change in Quality of Life by the FACT-Hep Scale

    Time frame: Baseline and 8 weeks of treatment with pioglitazone

    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

  5. Change in Pancreatic Intratumor Fat

    Time frame: Baseline and 8 weeks of treatment with pioglitazone

    Change in pancreatic intratumor fat will be measured by MRI

  6. Change in Body Fast Distribution

    Time frame: Baseline and 8 weeks of treatment with pioglitazone

    Change in body fast distribution will be measured by MRI

  7. Changes in Serum and MRI End Points

    Time frame: Baseline and 8 weeks of treatment with pioglitazone

    Compare changes in serum and MRI end points between pioglitazone

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Apr 24, 2013
Registry last updated
Mar 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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