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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pioglitazone & Chemotherapy in Patients without Diabetes | Experimental |
| |
| Pioglitazone & Chemotherapy in Patients with Diabetes | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pioglitazone | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum Adiponectin Level | We will obtain serum levels of adiponectin at baseline and after 8 weeks of treatment with pioglitazone. | Baseline and 8 weeks of treatment with pioglitazone |
| 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. | Baseline to 120 minutes post glucose bolus |
| 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 | Every 4 weeks while receiving treatment, up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weight | To describe changes in weight in patients with pancreas cancer receiving pioglitazone. | Baseline and every two weeks for 10 weeks, change between baseline and week 10 reported. |
| Number of Patients With Objective Response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Muhammad Beg, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pioglitazone and Chemotherapy Without Diabetes | 45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period. |
| FG001 | Pioglitazone and Chemotherapy - With Diabetes | 45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pioglitazone and Chemotherapy in Patients Without Diabetes | 45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period. |
| BG001 | Pioglitazone and Chemotherapy in Patients With Diabetes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | All Participants received the same treatment. However, results were analyzed separating those individuals with and without diabetes. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Serum Adiponectin Level | We will obtain serum levels of adiponectin at baseline and after 8 weeks of treatment with pioglitazone. | Posted | Mean | Standard Deviation | μg/ml | Baseline and 8 weeks of treatment with pioglitazone |
|
3 years, 4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pioglitazone and Chemotherapy Without Diabetes | 45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Muhammad Shaalan Beg | University of Texas Southwestern Medical Center | 214-648-4180 | muhammad.beg@utsouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 25, 2014 | Jan 24, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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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).
| 8 weeks of treatment with pioglitazone |
| 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. | Baseline and 8 weeks of treatment with pioglitazone |
| 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 | Baseline and 8 weeks of treatment with pioglitazone |
| Change in Pancreatic Intratumor Fat | Change in pancreatic intratumor fat will be measured by MRI | Baseline and 8 weeks of treatment with pioglitazone |
| Change in Body Fast Distribution | Change in body fast distribution will be measured by MRI | Baseline and 8 weeks of treatment with pioglitazone |
| Changes in Serum and MRI End Points | Compare changes in serum and MRI end points between pioglitazone | Baseline and 8 weeks of treatment with pioglitazone |
45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | The data was not collected for standard glucose tolerance test. | Posted | Baseline to 120 minutes post glucose bolus |
|
|
| 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 | Posted | Mean | Standard Deviation | ratio | Every 4 weeks while receiving treatment, up to 8 weeks |
|
|
|
| Secondary | Change in Weight | To describe changes in weight in patients with pancreas cancer receiving pioglitazone. | There was only 1 patient with data for "with Diabetes" arm, thus Standard Deviation for outcome is 0 for that arm | Posted | Mean | Standard Deviation | kg | Baseline and every two weeks for 10 weeks, change between baseline and week 10 reported. |
|
|
|
| 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). | Tumor assessment not collected. Data was not collected . | Posted | 8 weeks of treatment with pioglitazone |
|
|
| 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. | Data was not collected. | Posted | Baseline and 8 weeks of treatment with pioglitazone |
|
|
| 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 | Data was not collected | Posted | Baseline and 8 weeks of treatment with pioglitazone |
|
|
| Secondary | Change in Pancreatic Intratumor Fat | Change in pancreatic intratumor fat will be measured by MRI | Data was not collected. | Posted | Baseline and 8 weeks of treatment with pioglitazone |
|
|
| Secondary | Change in Body Fast Distribution | Change in body fast distribution will be measured by MRI | 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. | Posted | Baseline and 8 weeks of treatment with pioglitazone |
|
|
| Secondary | Changes in Serum and MRI End Points | Compare changes in serum and MRI end points between pioglitazone | 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. | Posted | Baseline and 8 weeks of treatment with pioglitazone |
|
|
| 9 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Pioglitazone and Chemotherapy - With Diabetes | 45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period. | 5 | 5 | 0 | 5 | 0 | 5 |
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |