Pioglitazone as Second-Line in Patients With Metastatic Pancreatic Cancer After Treatment With Gemcitabine
Primary Purpose
Pancreatic Cancer
Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
pioglitazone hydrochloride
laboratory biomarker analysis
questionnaire administration
quality-of-life assessment
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage IV pancreatic cancer, adenocarcinoma of the pancreas, recurrent pancreatic cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the pancreas
- Metastatic disease
- Previously treated disease
- Disease progression after first-line gemcitabine hydrochloride-based chemotherapy
- Radiologically measurable disease
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9 g/dL
- Serum creatinine < 1.5 times upper limit of normal (ULN) OR creatinine clearance > 45 mL/min
- Total bilirubin ≤ 1.5 times ULN
- AST and ALT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- No NYHA class III-IV congestive heart failure
- No unstable angina
- No second malignancy except for localized nonmelanoma skin cancer
- No psychiatric or addictive disorders that would preclude giving informed consent
PRIOR CONCURRENT THERAPY:
- Prior systemic therapy with fluorouracil, capecitabine, oxaliplatin, or erlotinib hydrochloride allowed
- More than 12 months since prior and no other concurrent thiazolinediones
- More than 6 months since prior treatment with immunosuppressive or immunomodulatory agents
- No other concurrent anticancer therapy
Sites / Locations
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Outcomes
Primary Outcome Measures
Insulin resistance markers as measured by standard glucose tolerance testing and serum adiponectin levels at baseline, every 4 weeks during therapy, and then at the completion of therapy
Fasting serum glucose and insulin levels as measured at baseline, every 4 weeks during therapy, and then at the completion of therapy
Changes in weight as measured at baseline, every 4 weeks during therapy, at the completion of therapy, and then monthly for 6 months and every 3 months for 2 years
Changes in ECOG performance status as measured at baseline, weekly during the first course of therapy, every 4 weeks during the rest of therapy, at the completion of therapy, and then monthly for 6 months and every 3 months for 2 years
Changes in symptoms and quality of life as measured by the validated FACT-Hep scale version 4 questionnaire at baseline, every 4 weeks during therapy, and then at the completion of therapy
Secondary Outcome Measures
Objective response (confirmed complete or partial response) as measured by RECIST criteria
Time to disease progression
Full Information
NCT ID
NCT00867126
First Posted
March 20, 2009
Last Updated
November 21, 2018
Sponsor
University of Texas Southwestern Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00867126
Brief Title
Pioglitazone as Second-Line in Patients With Metastatic Pancreatic Cancer After Treatment With Gemcitabine
Official Title
A Pilot Study of Pioglitazone as Second Line Therapy for Patients With Previously Treated Metastatic Adenocarcinoma of the Pancreas With Disease Progression After Gemcitabine Based Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Terminated
Why Stopped
low accrual
Study Start Date
March 2, 2009 (Actual)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas Southwestern Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
RATIONALE: Pioglitazone may slow the growth of tumor cells and may be an effective treatment for pancreatic cancer.
PURPOSE: This phase I trial is studying how well pioglitazone works as second-line therapy in treating patients with metastatic pancreatic cancer that progressed after treatment with gemcitabine.
Detailed Description
OBJECTIVES:
Primary
To describe changes in markers of insulin resistance, including serum adiponectin levels, standard glucose tolerance testing, and fasting serum glucose and insulin levels, in patients with previously treated metastatic adenocarcinoma of the pancreas treated with pioglitazone hydrochloride as second-line therapy.
To describe changes in weight in these patients.
To describe changes in ECOG performance status in these patients.
To describe changes in symptoms and quality of life of these patients using the validated FACT-Hep scale version 4 questionnaire.
Secondary
To determine the tumor response as measured by RECIST criteria in these patients.
To determine the time to disease progression in these patients.
OUTLINE: Patients receive oral pioglitazone hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients complete a quality-of-life questionnaire at baseline, every 4 weeks during therapy, and then at the completion of therapy.
Patients undergo blood sample collection at baseline, every 4 weeks during therapy, and then at the completion of therapy for laboratory biomarker studies. Samples are analyzed for levels of insulin resistance markers (adiponectin, glucose, and insulin).
After completion of study therapy, patients are followed monthly for 6 months and then every 3 months for 2 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
stage IV pancreatic cancer, adenocarcinoma of the pancreas, recurrent pancreatic cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
pioglitazone hydrochloride
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Primary Outcome Measure Information:
Title
Insulin resistance markers as measured by standard glucose tolerance testing and serum adiponectin levels at baseline, every 4 weeks during therapy, and then at the completion of therapy
Title
Fasting serum glucose and insulin levels as measured at baseline, every 4 weeks during therapy, and then at the completion of therapy
Title
Changes in weight as measured at baseline, every 4 weeks during therapy, at the completion of therapy, and then monthly for 6 months and every 3 months for 2 years
Title
Changes in ECOG performance status as measured at baseline, weekly during the first course of therapy, every 4 weeks during the rest of therapy, at the completion of therapy, and then monthly for 6 months and every 3 months for 2 years
Title
Changes in symptoms and quality of life as measured by the validated FACT-Hep scale version 4 questionnaire at baseline, every 4 weeks during therapy, and then at the completion of therapy
Secondary Outcome Measure Information:
Title
Objective response (confirmed complete or partial response) as measured by RECIST criteria
Title
Time to disease progression
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the pancreas
Metastatic disease
Previously treated disease
Disease progression after first-line gemcitabine hydrochloride-based chemotherapy
Radiologically measurable disease
PATIENT CHARACTERISTICS:
ECOG performance status 0-2
ANC ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 9 g/dL
Serum creatinine < 1.5 times upper limit of normal (ULN) OR creatinine clearance > 45 mL/min
Total bilirubin ≤ 1.5 times ULN
AST and ALT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 3 months after completion of study treatment
No NYHA class III-IV congestive heart failure
No unstable angina
No second malignancy except for localized nonmelanoma skin cancer
No psychiatric or addictive disorders that would preclude giving informed consent
PRIOR CONCURRENT THERAPY:
Prior systemic therapy with fluorouracil, capecitabine, oxaliplatin, or erlotinib hydrochloride allowed
More than 12 months since prior and no other concurrent thiazolinediones
More than 6 months since prior treatment with immunosuppressive or immunomodulatory agents
No other concurrent anticancer therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yull E. Arriaga, MD
Organizational Affiliation
Simmons Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pioglitazone as Second-Line in Patients With Metastatic Pancreatic Cancer After Treatment With Gemcitabine
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