Pioglitazone as Second-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer That Progressed After Treatment With Gemcitabine - Full Text View

Sponsor:	Simmons Cancer Center
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00867126

Purpose

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.

Condition	Intervention	Phase
Pancreatic Cancer	Drug: pioglitazone hydrochloride Other: laboratory biomarker analysis Other: questionnaire administration Procedure: quality-of-life assessment	Phase I

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Diabetes Medicines Pancreatic Cancer

Drug Information available for: Gemcitabine Pioglitazone Pioglitazone hydrochloride Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

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 [ Designated as safety issue: No ]
Fasting serum glucose and insulin levels as measured at baseline, every 4 weeks during therapy, and then at the completion of therapy [ Designated as safety issue: No ]
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 [ Designated as safety issue: No ]
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 [ Designated as safety issue: No ]
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 [ Designated as safety issue: No ]

Secondary Outcome Measures:

Objective response (confirmed complete or partial response) as measured by RECIST criteria [ Designated as safety issue: No ]
Time to disease progression [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	February 2009
Estimated Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00867126

Locations

United States, Texas
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Recruiting
Dallas, Texas, United States, 75390
Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a 866-460-4673; 214-648-7097

Sponsors and Collaborators

Simmons Cancer Center

Investigators

Principal Investigator:

Yull E. Arriaga, MD

Simmons Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Regulatory Affairs Associate, Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
ClinicalTrials.gov Identifier:	NCT00867126 History of Changes
Other Study ID Numbers:	CDR0000637622, SCCC-02208
Study First Received:	March 20, 2009
Last Updated:	April 2, 2009
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage IV pancreatic cancer
adenocarcinoma of the pancreas
recurrent pancreatic cancer

Additional relevant MeSH terms:

Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Pioglitazone

Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Hypoglycemic Agents

ClinicalTrials.gov processed this record on February 09, 2012