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


Phase 2
18 Years
N/A
Not Enrolling
Both
Cancer of the Pancreas

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Trial Information

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


Inclusion Criteria:



- Signed informed consent

- Histologically proven adenocarcinoma of the pancreas

- Radiologically measureable 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 Thiazolinedione (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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Improvement in insulin resistance markers

Outcome Description:

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

Outcome Time Frame:

Baseline 4 weeks and 8 weeks of treatment

Safety Issue:

Yes

Authority:

United States: Data and Safety Monitoring Board

Study ID:

STU 072012-036

NCT ID:

NCT01838317

Start Date:

April 2013

Completion Date:

Related Keywords:

  • Cancer of the Pancreas
  • Pancreatic Neoplasms

Name

Location

Ut Southwestern Medical Center Dallas, Texas  75390