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

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ClinicalTrials.gov Identifier: NCT01838317
Recruitment Status : Completed
First Posted : April 24, 2013
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

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.

Condition or disease Intervention/treatment Phase
Cancer of the Pancreas Drug: Pioglitazone Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Pioglitazone for Patients With Cancer of the Pancreas
Study Start Date : May 2013
Actual Primary Completion Date : September 20, 2017
Actual Study Completion Date : September 20, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pioglitazone Drug: Pioglitazone



Primary Outcome Measures :
  1. Improvement in insulin resistance markers [ Time Frame: Baseline 4 weeks and 8 weeks of treatment ]
    1. Change in serum adiponectin level. We will obtain serum levels of adiponectin at baseline and after 8 weeks of treatment with pioglitazone.
    2. Changes 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.
    3. Fasting levels 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 :
  1. Change in weight [ Time Frame: Every 2 weeks for 10 weeks ]
    To describe changes in weight in patients with pancreas cancer receiving pioglitazone.


Other Outcome Measures:
  1. ECOG Performance Status [ Time Frame: Every 2 weeks for 10 weeks ]
    Changes in ECOG performance status in patients with pancreas cancer receiving pioglitazone.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01838317


Locations
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United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Muhammad Beg, MD UT Southwestern Medical Center

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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01838317     History of Changes
Other Study ID Numbers: STU 072012-036
First Posted: April 24, 2013    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Pioglitazone
Pancrelipase
Hypoglycemic Agents
Physiological Effects of Drugs
Gastrointestinal Agents