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

• Sponsor: University of Texas Southwestern Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01838317
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arms: 2
• Duration (Months): 52.7
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: Non-Randomized
• 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 1, 2013
• Actual Primary Completion Date: Sep 20, 2017
• Actual Study Completion Date: Sep 20, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pioglitazone & Chemotherapy in Patients without Diabetes	Drug: Pioglitazone
Experimental: Pioglitazone & Chemotherapy in Patients with Diabetes	Drug: Pioglitazone

Outcome Measures

Primary Outcome Measures

1. Change in Serum Adiponectin Level [Baseline and 8 weeks of treatment with pioglitazone]

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

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

   We will perform the area under the oral glucose tolerance test at baseline and after 8 weeks of treatment with pioglitazone.

3. Glucose to Insulin Ratio [Every 4 weeks while receiving treatment, up to 8 weeks]

   Glucose to insulin ratio will be measured by taking the ratio of fasting level 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 [Baseline and every two weeks for 10 weeks, change between baseline and week 10 reported.]

   To describe changes in weight in patients with pancreas cancer receiving pioglitazone.

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

   Objective response is the proportion of patients with confirmed complete response (CR) or confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST).

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

   The ECOG Scale of Performance Status measures patients' performance status. Possible grades range from 0 to 5, with lower grade indicating a better performance status.

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

   The FACT-Hep Scale (version 4) measures quality of life, It consists of five subscales: (1) physical well-being (PWB); (2) social and family well-being (SFWB); (3) emotional well-being (EWB); (4) functional well-being (FWB); and the hepatobiliary cancer subscale (HepCS). Possible scores range from 0 to 180, with lower scores indicating a better quality of life

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

   Change in pancreatic intratumor fat will be measured by MRI

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

   Change in body fast distribution will be measured by MRI

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

   Compare changes in serum and MRI end points between pioglitazone

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UT Southwestern Medical Center	Dallas	Texas	United States	75390

Sponsors and Collaborators

• University of Texas Southwestern Medical Center

Investigators

• Principal Investigator: Muhammad Beg, MD, UT Southwestern Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 25, 2014

More Information

Publications

None provided.

• Responsible Party: Muhammad Beg, Associate Professor of Medicine, University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT01838317
• Other Study ID Numbers: STU 072012-036
• First Posted: Apr 24, 2013
• Last Update Posted: Mar 1, 2021
• Last Verified: Feb 1, 2021

• Additional relevant MeSH terms: Pancreatic Neoplasms; Pioglitazone

Study Results

Participant Flow

Arm/Group Title	Pioglitazone and Chemotherapy Without Diabetes	Pioglitazone and Chemotherapy - With Diabetes
Arm/Group Description	45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.	45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.
Period Title: Overall Study
STARTED	9	5
COMPLETED	9	5
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Pioglitazone and Chemotherapy in Patients Without Diabetes	Pioglitazone and Chemotherapy in Patients With Diabetes	Total
Arm/Group Description	45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.	45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.	Total of all reporting groups
Overall Participants	9	5	14
Age (years) [Mean (Standard Deviation) ]
Pioglitazone and Chemotherapy - Without Diabetes	58.26 (8.52)	64.84 (8.87)	61.55 (8.70)
Sex: Female, Male (Count of Participants)
Female	6 66.7%	3 60%	9 64.3%
Male	3 33.3%	2 40%	5 35.7%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	9 100%	5 100%	14 100%

Outcome Measures

1. Primary Outcome

Title	Change in Serum Adiponectin Level
Description	We will obtain serum levels of adiponectin at baseline and after 8 weeks of treatment with pioglitazone.
Time Frame	Baseline and 8 weeks of treatment with pioglitazone

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pioglitazone and Chemotherapy Without Diabetes	Pioglitazone and Chemotherapy - With Diabetes
Arm/Group Description	45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.	45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.
Measure Participants	9	5
Mean (Standard Deviation) [μg/ml]	34.47 (27.42)	29.77 (12.06)

2. Primary Outcome

Title	Change in Standard Glucose Tolerance Test
Description	We will perform the area under the oral glucose tolerance test at baseline and after 8 weeks of treatment with pioglitazone.
Time Frame	Baseline to 120 minutes post glucose bolus

Outcome Measure Data

Analysis Population Description

The data was not collected for standard glucose tolerance test.

Arm/Group Title	Pioglitazone and Chemotherapy Without Diabetes	Pioglitazone and Chemotherapy - With Diabetes
Arm/Group Description	45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.	45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.
Measure Participants	0	0

3. Primary Outcome

Title	Glucose to Insulin Ratio
Description	Glucose to insulin ratio will be measured by taking the ratio of fasting level of serum glucose and insulin. We will obtain serum levels of fasting glucose and insulin every four weeks in all patients receiving pioglitazone
Time Frame	Every 4 weeks while receiving treatment, up to 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pioglitazone and Chemotherapy Without Diabetes	Pioglitazone and Chemotherapy - With Diabetes
Arm/Group Description	45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.	45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.
Measure Participants	9	5
Mean (Standard Deviation) [ratio]	0.81 (13.54)	-6.23 (0.08)

4. Secondary Outcome

Title	Change in Weight
Description	To describe changes in weight in patients with pancreas cancer receiving pioglitazone.
Time Frame	Baseline and every two weeks for 10 weeks, change between baseline and week 10 reported.

Outcome Measure Data

Analysis Population Description

There was only 1 patient with data for "with Diabetes" arm, thus Standard Deviation for outcome is 0 for that arm

Arm/Group Title	Pioglitazone and Chemotherapy Without Diabetes	Pioglitazone and Chemotherapy - With Diabetes
Arm/Group Description	45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.	45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.
Measure Participants	9	1
Mean (Standard Deviation) [kg]	2.57 (3.98)	-4.01 (0)

5. Secondary Outcome

Title	Number of Patients With Objective Response
Description	Objective response is the proportion of patients with confirmed complete response (CR) or confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST).
Time Frame	8 weeks of treatment with pioglitazone

Outcome Measure Data

Analysis Population Description

Tumor assessment not collected. Data was not collected .

Arm/Group Title	Pioglitazone and Chemotherapy Without Diabetes	Pioglitazone and Chemotherapy - With Diabetes
Arm/Group Description	45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.	45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.
Measure Participants	0	0

6. Secondary Outcome

Title	Change in Patients' Performance Status by the Eastern Oncology Cooperative Group (ECOG) Scale of Performance Status
Description	The ECOG Scale of Performance Status measures patients' performance status. Possible grades range from 0 to 5, with lower grade indicating a better performance status.
Time Frame	Baseline and 8 weeks of treatment with pioglitazone

Outcome Measure Data

Analysis Population Description

Data was not collected.

Arm/Group Title	Pioglitazone and Chemotherapy Without Diabetes	Pioglitazone and Chemotherapy - With Diabetes
Arm/Group Description	45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.	45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.
Measure Participants	0	0

7. Secondary Outcome

Title	Change in Quality of Life by the FACT-Hep Scale
Description	The FACT-Hep Scale (version 4) measures quality of life, It consists of five subscales: (1) physical well-being (PWB); (2) social and family well-being (SFWB); (3) emotional well-being (EWB); (4) functional well-being (FWB); and the hepatobiliary cancer subscale (HepCS). Possible scores range from 0 to 180, with lower scores indicating a better quality of life
Time Frame	Baseline and 8 weeks of treatment with pioglitazone

Outcome Measure Data

Analysis Population Description

Data was not collected

Arm/Group Title	Pioglitazone and Chemotherapy Without Diabetes	Pioglitazone and Chemotherapy - With Diabetes
Arm/Group Description	45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.	45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.
Measure Participants	0	0

8. Secondary Outcome

Title	Change in Pancreatic Intratumor Fat
Description	Change in pancreatic intratumor fat will be measured by MRI
Time Frame	Baseline and 8 weeks of treatment with pioglitazone

Outcome Measure Data

Analysis Population Description

Data was not collected.

Arm/Group Title	Pioglitazone and Chemotherapy Without Diabetes	Pioglitazone and Chemotherapy - With Diabetes
Arm/Group Description	45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.	45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.
Measure Participants	0	0

9. Secondary Outcome

Title	Change in Body Fast Distribution
Description	Change in body fast distribution will be measured by MRI
Time Frame	Baseline and 8 weeks of treatment with pioglitazone

Outcome Measure Data

Analysis Population Description

This data was not collected as the number of cases with pre and post scans who were with and without DM (Diabetes Mellitus) was too small.

Arm/Group Title	Pioglitazone and Chemotherapy Without Diabetes	Pioglitazone and Chemotherapy - With Diabetes
Arm/Group Description	45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.	45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.
Measure Participants	0	0

10. Secondary Outcome

Title	Changes in Serum and MRI End Points
Description	Compare changes in serum and MRI end points between pioglitazone
Time Frame	Baseline and 8 weeks of treatment with pioglitazone

Outcome Measure Data

Analysis Population Description

This data was not collected as the number of cases with pre and post scans who were with and without DM (Diabetes Mellitus) was too small.

Arm/Group Title	Pioglitazone and Chemotherapy Without Diabetes	Pioglitazone and Chemotherapy - With Diabetes
Arm/Group Description	45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.	45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.
Measure Participants	0	0

Adverse Events

Time Frame	3 years, 4 months
Arm/Group Title	Pioglitazone and Chemotherapy Without Diabetes		Pioglitazone and Chemotherapy - With Diabetes
Arm/Group Description	45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.		45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.
All Cause Mortality
	Pioglitazone and Chemotherapy Without Diabetes		Pioglitazone and Chemotherapy - With Diabetes
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/9 (100%)		5/5 (100%)
Serious Adverse Events
	Pioglitazone and Chemotherapy Without Diabetes		Pioglitazone and Chemotherapy - With Diabetes
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/5 (0%)
Other (Not Including Serious) Adverse Events
	Pioglitazone and Chemotherapy Without Diabetes		Pioglitazone and Chemotherapy - With Diabetes
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/5 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.