Pancreatic Cancer Research

Clinical trialPhase 2Completed

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

Outcome
Outcome unknown
Phase
Phase 2
Status
Completed
Study type
Interventional
Start
May 2013
Expected end
20 September 2017
Enrollment
14 participants
Sites
1
Primary outcomes
Change in Serum Adiponectin Level; Change in Standard Glucose Tolerance Test; Glucose to Insulin Ratio
Sponsor
Other
Results posted
2021-03-01
Last update
1 March 2021

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Brief summary public domain (ClinicalTrials.gov)

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.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Change in Serum Adiponectin Level [Baseline and 8 weeks of treatment with pioglitazone]. Mean, μg/ml (Standard Deviation). Pioglitazone and Chemotherapy Without Diabetes (n=9): 34.47 (27.42); Pioglitazone and Chemotherapy - With Diabetes (n=5): 29.77 (12.06).

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Change in Standard Glucose Tolerance Test [Baseline to 120 minutes post glucose bolus].

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Glucose to Insulin Ratio [Every 4 weeks while receiving treatment, up to 8 weeks]. Mean, ratio (Standard Deviation). Pioglitazone and Chemotherapy Without Diabetes (n=9): 0.81 (13.54); Pioglitazone and Chemotherapy - With Diabetes (n=5): -6.23 (0.08).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change in Weight [Baseline and every two weeks for 10 weeks, change between baseline and week 10 reported.]. Mean, kg (Standard Deviation). Pioglitazone and Chemotherapy Without Diabetes (n=9): 2.57 (3.98); Pioglitazone and Chemotherapy - With Diabetes (n=1): -4.01 (0).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Number of Patients With Objective Response [8 weeks of treatment with pioglitazone].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change in Patients' Performance Status by the Eastern Oncology Cooperative Group (ECOG) Scale of Performance Status [Baseline and 8 weeks of treatment with pioglitazone].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change in Quality of Life by the FACT-Hep Scale [Baseline and 8 weeks of treatment with pioglitazone].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change in Pancreatic Intratumor Fat [Baseline and 8 weeks of treatment with pioglitazone].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change in Body Fast Distribution [Baseline and 8 weeks of treatment with pioglitazone].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Changes in Serum and MRI End Points [Baseline and 8 weeks of treatment with pioglitazone].