Cancer of the PancreasPhase 2NCT01838317
A Phase II Study of Pioglitazone for Patients With Cancer of the Pancreas
A Phase 2 study testing Pioglitazone in people with Cancer of the Pancreas, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of the Pancreas
- What is being tested?
- Pioglitazone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to 20 Sep 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Histologically proven adenocarcinoma of the pancreas
- Radiologically measurable disease
- ECOG functional status 0-2
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cancer of the Pancreas
- Being tested
- Pioglitazone
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PioglitazoneDrug
| Study group | Role | What they receive |
|---|---|---|
| Pioglitazone & Chemotherapy in Patients without Diabetes | Experimental | Not described Receives: Drug: Pioglitazone |
| Pioglitazone & Chemotherapy in Patients with Diabetes | Experimental | Not described Receives: Drug: Pioglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Adiponectin Level
We will obtain serum levels of adiponectin at baseline and after 8 weeks of treatment with pioglitazone.
Measured: 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.
Measured: 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
Measured: Every 4 weeks while receiving treatment, up to 8 weeks
Secondary outcomes (7)
Change in Weight
To describe changes in weight in patients with pancreas cancer receiving pioglitazone.
Measured: Baseline and every two weeks for 10 weeks, change between baseline and week 10 reported.
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).
Measured: 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.
Measured: 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
Measured: Baseline and 8 weeks of treatment with pioglitazone
Change in Pancreatic Intratumor Fat
Change in pancreatic intratumor fat will be measured by MRI
Measured: Baseline and 8 weeks of treatment with pioglitazone
Change in Body Fast Distribution
Change in body fast distribution will be measured by MRI
Measured: 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
Measured: Baseline and 8 weeks of treatment with pioglitazone
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startMay 2013
- Primary completion20 Sep 2017
- Study completion20 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cancer of the PancreasStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Beg, University of Texas Southwestern Medical Center
- Investigators
- Muhammad Beg, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01838317
- Sponsor's protocol ID
- STU 072012-036
- Status last verified
- Feb 2021
- First submitted
- 16 Apr 2013
- Last updated
- 1 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Pioglitazone for Patients With Cancer of the Pancreas
- ClinicalTrials.gov ID
- NCT01838317
- Acronym / sponsor ID
- STU 072012-036
- Conditions
- Cancer of the Pancreas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- 20 Sep 2017 (actual)
- Study completion
- 20 Sep 2017 (actual)
- First posted
- 24 Apr 2013 (estimated)
- Results
- Posted 1 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pioglitazone & Chemotherapy in Patients without Diabetes | Experimental | Drug: Pioglitazone |
| Pioglitazone & Chemotherapy in Patients with Diabetes | Experimental | Drug: Pioglitazone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent
- Histologically proven adenocarcinoma of the pancreas
- Radiologically measurable disease
- ECOG functional status 0-2
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pioglitazone | Drug | Pioglitazone & Chemotherapy in Patients with Diabetes, Pioglitazone & Chemotherapy in Patients without Diabetes |
Primary outcome
Change in Serum Adiponectin Level
Time frame: 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
Time frame: 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
Time frame: 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
7 secondary outcomes
Change in Weight
Time frame: Baseline and every two weeks for 10 weeks, change between baseline and week 10 reported.
Number of Patients With Objective Response
Time frame: 8 weeks of treatment with pioglitazone
Change in Patients' Performance Status by the Eastern Oncology Cooperative Group (ECOG) Scale of Performance Status
Time frame: Baseline and 8 weeks of treatment with pioglitazone
Change in Quality of Life by the FACT-Hep Scale
Time frame: Baseline and 8 weeks of treatment with pioglitazone
Change in Pancreatic Intratumor Fat
Time frame: Baseline and 8 weeks of treatment with pioglitazone
Change in Body Fast Distribution
Time frame: Baseline and 8 weeks of treatment with pioglitazone
Changes in Serum and MRI End Points
Time frame: Baseline and 8 weeks of treatment with pioglitazone
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Beg, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pioglitazone in people with Cancer of the Pancreas, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Adiponectin Level (time frame: Baseline and 8 weeks of treatment with pioglitazone). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2021.