Cancer of the Pancreas
Conditions
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.
Interventions
DRUGPioglitazone
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Change in Pancreatic Intratumor Fat | Baseline and 8 weeks of treatment with pioglitazone | Change in pancreatic intratumor fat will be measured by MRI |
| 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. |
| 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 |
| Change in Body Fast Distribution | Baseline and 8 weeks of treatment with pioglitazone | Change in body fast distribution will be measured by MRI |
| 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). |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pioglitazone and Chemotherapy in Patients Without Diabetes 45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period. | 9 |
| Pioglitazone and Chemotherapy in Patients With Diabetes 45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period. | 5 |
| Total | 14 |
Baseline characteristics
| Characteristic | Pioglitazone and Chemotherapy in Patients With Diabetes | Total | Pioglitazone and Chemotherapy in Patients Without Diabetes |
|---|---|---|---|
| Age, Continuous Pioglitazone and Chemotherapy - Without Diabetes | 64.84 years STANDARD_DEVIATION 8.87 | 61.55 years STANDARD_DEVIATION 8.7 | 58.26 years STANDARD_DEVIATION 8.52 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 5 participants | 14 participants | 9 participants |
| Sex: Female, Male Female | 3 Participants | 9 Participants | 6 Participants |
| Sex: Female, Male Male | 2 Participants | 5 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 9 / 9 | 5 / 5 |
| other Total, other adverse events | 0 / 9 | 0 / 5 |
| serious Total, serious adverse events | 0 / 9 | 0 / 5 |
Outcome results
Primary
Change in Serum Adiponectin Level
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pioglitazone and Chemotherapy Without Diabetes | Change in Serum Adiponectin Level | 34.47 μg/ml | Standard Deviation 27.42 |
| Pioglitazone and Chemotherapy - With Diabetes | Change in Serum Adiponectin Level | 29.77 μg/ml | Standard Deviation 12.06 |
Primary
Change 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.
Time frame: Baseline to 120 minutes post glucose bolus
Population: The data was not collected for standard glucose tolerance test.
Primary
Glucose to Insulin Ratio
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pioglitazone and Chemotherapy Without Diabetes | Glucose to Insulin Ratio | 0.81 ratio | Standard Deviation 13.54 |
| Pioglitazone and Chemotherapy - With Diabetes | Glucose to Insulin Ratio | -6.23 ratio | Standard Deviation 0.08 |
Secondary
Change in Body Fast Distribution
Change in body fast distribution will be measured by MRI
Time frame: Baseline and 8 weeks of treatment with pioglitazone
Population: 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.
Secondary
Change in Pancreatic Intratumor Fat
Change in pancreatic intratumor fat will be measured by MRI
Time frame: Baseline and 8 weeks of treatment with pioglitazone
Population: Data was not collected.
Secondary
Change in Patients' Performance Status by the Eastern Oncology Cooperative Group (ECOG) Scale of Performance Status
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
Population: Data was not collected.
Secondary
Change in Quality of Life by the FACT-Hep Scale
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
Population: Data was not collected
Secondary
Change in Weight
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.
Population: There was only 1 patient with data for with Diabetes arm, thus Standard Deviation for outcome is 0 for that arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pioglitazone and Chemotherapy Without Diabetes | Change in Weight | 2.57 kg | Standard Deviation 3.98 |
| Pioglitazone and Chemotherapy - With Diabetes | Change in Weight | -4.01 kg | Standard Deviation 0 |
Secondary
Changes in Serum and MRI End Points
Compare changes in serum and MRI end points between pioglitazone
Time frame: Baseline and 8 weeks of treatment with pioglitazone
Population: 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.
Secondary
Number of Patients With Objective Response
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
Population: Tumor assessment not collected. Data was not collected .