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

NCT00867126 | Terminated Early Phase 1 DMC FDA Drug

• 3 other identifiers: SCCC-02208CDR0000637622NCI-2011-01036
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

stage IV pancreatic cancer; adenocarcinoma of the pancreas; recurrent pancreatic cancer

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Objective response (confirmed complete or partial response) as measured by RECIST criteria

• Time to disease progression

Interventions

pioglitazone hydrochloride DRUG

laboratory biomarker analysis OTHER

questionnaire administration OTHER

quality-of-life assessment PROCEDURE

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

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

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yull E. Arriaga, MD

  Simmons Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2009
• First Posted: March 23, 2009
• Study Start: March 2, 2009
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: November 26, 2018

Record last verified: 2018-11

Locations

US (1)