Phase 2 N=14 Treatment

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

Cancer of the Pancreas

Bottom Line

View on ClinicalTrials.gov: NCT01838317 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2021

Primary outcome: Primary: Change in Serum Adiponectin Level — 34.47; 29.77 μg/ml

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Pioglitazone (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Texas Southwestern Medical Center
Primary completion: Sep 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Serum Adiponectin Level	34.47; 29.77	—
PRIMARY Change in Standard Glucose Tolerance Test	—	—
PRIMARY Glucose to Insulin Ratio	0.81; -6.23	—
SECONDARY Change in Weight	2.57; -4.01	—
SECONDARY Number of Patients With Objective Response	—	—
SECONDARY Change in Patients' Performance Status by the Eastern Oncology Cooperative Group (ECOG) Scale of Performance Status	—	—
SECONDARY Change in Quality of Life by the FACT-Hep Scale	—	—
SECONDARY Change in Pancreatic Intratumor Fat	—	—
SECONDARY Change in Body Fast Distribution	—	—
SECONDARY Changes in Serum and MRI End Points	—	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01838317). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.