Clinical trial NCT01838317: A Phase II Study of Pioglitazone for Patients With Cancer of the Pancreas
Official title: A Phase II Study of Pioglitazone for Patients With Cancer of the Pancreas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer of the Pancreas
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2013-04-24
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Serum Adiponectin Level
timeFrame: Baseline and 8 weeks of treatment with pioglitazone
measure: Change in Standard Glucose Tolerance Test
timeFrame: Baseline to 120 minutes post glucose bolus
measure: Glucose to Insulin Ratio
timeFrame: Every 4 weeks while receiving treatment, up to 8 weeks
Secondary outcomes:
measure: Change in Weight
timeFrame: Baseline and every two weeks for 10 weeks, change between baseline and week 10 reported.
measure: Number of Patients With Objective Response
timeFrame: 8 weeks of treatment with pioglitazone
measure: Change in Patients' Performance Status by the Eastern Oncology Cooperative Group (ECOG) Scale of Performance Status
timeFrame: Baseline and 8 weeks of treatment with pioglitazone
measure: Change in Quality of Life by the FACT-Hep Scale
timeFrame: Baseline and 8 weeks of treatment with pioglitazone
measure: Change in Pancreatic Intratumor Fat
timeFrame: Baseline and 8 weeks of treatment with pioglitazone
measure: Change in Body Fast Distribution
timeFrame: Baseline and 8 weeks of treatment with pioglitazone
measure: Changes in Serum and MRI End Points
timeFrame: Baseline and 8 weeks of treatment with pioglitazone
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Muhammad Beg, MD
role: PRINCIPAL_INVESTIGATOR
References: