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Cetuximab and Trastuzumab in Treating Patients With Metastatic Pancreatic Cancer That Progressed After Previous Treatment With Gemcitabine (THERAPY)

Phase I-II Study Evaluating Combined Treatment of Cetuximab and Trastuzumab in Metastatic Pancreatic Cancer Patients Progressing After Gemcitabine Based Chemotherapy.(THERAPY)

RATIONALE: Monoclonal antibodies, such as cetuximab and trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving cetuximab together with trastuzumab may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of trastuzumab when given together with cetuximab and to see how well it works in treating patients with metastatic pancreatic cancer that progressed after previous treatment with gemcitabine.

Studieoversigt

Status

Afsluttet

Detaljeret beskrivelse

OBJECTIVES:

Primary

  • Determine the recommended dose of trastuzumab when given with cetuximab in patients with metastatic pancreatic cancer that progressed after gemcitabine-based chemotherapy. (Phase I)
  • Evaluate the objective response rate as assessed by RECIST criteria. (Phase II)

Secondary

  • Evaluate the safety profile as assessed by NCI CTCAE v3.0.
  • Evaluate progression-free survival.
  • Evaluate overall survival.

OUTLINE: This is a multicenter, phase I dose-escalation study of trastuzumab followed by a phase II study.

Patients receive cetuximab IV over 1-2 hours and trastuzumab IV over 30-90 minutes on day 1. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

33

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Montpellier, Frankrig, 34298
        • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Histologically confirmed metastatic adenocarcinoma of the pancreas

    • Progressed after first-line or adjuvant gemcitabine-based chemotherapy
  • Measurable disease as assessed by RECIST criteria
  • No known brain metastasis or symptomatic carcinomatous leptomeningitis

PATIENT CHARACTERISTICS:

  • WHO performance status 0-1
  • Life expectancy ≥ 3 months
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9 g/dL
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Total bilirubin ≤ 2.5 times ULN
  • ALT/AST ≤ 5 times ULN
  • LVEF ≥ 55%
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No significant comorbidities, including any of the following:

    • Cardiovascular disease
    • Documented history of congestive heart failure
    • Uncontrolled, high-risk arrhythmia
    • Angina pectoris requiring treatment
    • Clinically significant valvular disease
    • Evidence of transmural myocardial infarction by ECG
    • Uncontrolled hypertension
    • Active bleeding
    • Clinically significant active infection
    • Severe dyspnea at rest
    • Oxygen-dependency
  • No other malignancy except basal cell carcinoma of the skin
  • No severe hypersensitivity to cetuximab or trastuzumab
  • No medical or psychological condition that would preclude study completion or giving informed consent
  • No legal incapacity or limited legal capacity

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior cetuximab or trastuzumab
  • No other concurrent experimental drugs or anticancer therapy

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: cetuximab, trastuzumab
Cetuximab at the initial dose of 400 mg/m² (J1S1) as a 2-hour infusion and then at the 250 mg/m² dose as a 1-hour infusion in subsequent weeks.

Two dose levels of trastuzumab will be evaluated for Phase 1:

  • Level 1: a loading dose of 3 mg/kg as a 90-minute intravenous infusion at J1S1 and then 1.5 mg/kg as a 30-minute intravenous infusion for all subsequent weekly administrations;
  • Level 2: a loading dose of 4 mg/kg as a 90-minute intravenous infusion at J1S1 and then 2 mg/kg as a 30-minute intravenous infusion for all subsequent weekly administrations.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Recommended dose of trastuzumab when given with cetuximab (Phase I)
Tidsramme: 15 days
From baseline to the end of treatment
15 days
Objective response rate as assessed by RECIST criteria (Phase II)
Tidsramme: Approximately 8 weeks
From baseline to the end of treatment
Approximately 8 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-free survival
Tidsramme: Approximately 36 months
From baseline to the end of study
Approximately 36 months
Overall survival
Tidsramme: Approximately 36 months
From baseline to the end of study
Approximately 36 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Marc Ychou, MD, PhD, Institut du Cancer de Montpellier - Val d'Aurelle

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2008

Primær færdiggørelse (Faktiske)

1. april 2010

Studieafslutning (Faktiske)

1. marts 2011

Datoer for studieregistrering

Først indsendt

17. juni 2009

Først indsendt, der opfyldte QC-kriterier

17. juni 2009

Først opslået (Skøn)

18. juni 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. april 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. april 2019

Sidst verificeret

1. august 2017

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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