Pioglitazone as Second-Line in Patients With Metastatic Pancreatic Cancer After Treatment With Gemcitabine

NCT ID: NCT00867126

Last Updated: 2018-11-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-02
• Study Completion Date: 2012-02-29

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

pioglitazone hydrochloride

Intervention Type: DRUG

laboratory biomarker analysis

Intervention Type: OTHER

questionnaire administration

Intervention Type: OTHER

quality-of-life assessment

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yull E. Arriaga, MD

Role: PRINCIPAL_INVESTIGATOR

Simmons Cancer Center

Locations

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, United States

Countries

United States

Other Identifiers

CDR0000637622

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2011-01036

Identifier Type: REGISTRY

Identifier Source: secondary_id

SCCC-02208

Identifier Type: -

Identifier Source: org_study_id