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

21 november 2018 uppdaterad av: University of Texas Southwestern Medical Center

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

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.

Studieöversikt

Status

Avslutad

Betingelser

Bukspottskörtelcancer

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

Fas

Tidig fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Förenta staterna
- Texas
  - Dallas, Texas, Förenta staterna, 75390
    - Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 120 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Primärt syfte: Behandling
Tilldelning: N/A
Interventionsmodell: Enskild gruppuppgift
Maskning: Ingen (Open Label)

Vad mäter studien?

Primära resultatmått

Resultatmått
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

Sekundära resultatmått

Resultatmått
Dags för sjukdomsprogression
Objective response (confirmed complete or partial response) as measured by RECIST criteria

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Texas Southwestern Medical Center

Utredare

Huvudutredare: Yull E. Arriaga, MD, Simmons Cancer Center

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

2 mars 2009

Primärt slutförande (Faktisk)

1 februari 2012

Avslutad studie (Faktisk)

1 februari 2012

Studieregistreringsdatum

Först inskickad

20 mars 2009

Först inskickad som uppfyllde QC-kriterierna