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Liposome-Encapsulated Doxorubicin Citrate and Carboplatin in Treating Patients With Advanced or Metastatic Recurrent Endometrial Cancer

6. august 2013 opdateret af: Medical University Innsbruck

Phase II Multicenter Trial of the Austrian AGO With the Combination of Liposomal Doxorubicin (Myocet®) and Carboplatin in Primary Advanced or Metastatic and Recurrent Endometrial Cancer

RATIONALE: Drugs used in chemotherapy, such as liposome-encapsulated doxorubicin citrate and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well liposome-encapsulated doxorubicin citrate given together with carboplatin works in treating patients with advanced or metastatic recurrent endometrial cancer.

Studieoversigt

Detaljeret beskrivelse

OBJECTIVES:

Primary

  • To assess activity of the combination of liposome-encapsulated doxorubicin citrate and carboplatin in patients with primary advanced or metastatic recurrent carcinoma of the endometrium.

Secondary

  • To assess the toxicity and feasibility of this regimen in these patients.
  • To determine the progression-free survival and overall survival of these patients.

OUTLINE: This is a multicenter study.

Patients receive liposome-encapsulated doxorubicin citrate IV over 1 hour followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6-9 courses in the absence of disease progression or unacceptable toxicity.

Tissue array and immunohistochemistry analysis are conducted on paraffin-embedded tumor blocks of the primarily operated tissue of all patients for different markers (e.g., progesterone-/estrogen receptor, HER2-receptor, soluble L1-molecule, Topo 2a) to examine tumor characteristics.

Quality of life is assessed at baseline, during study treatment, at completion of study treatment, and then at 1 year after completion of study treatment.

After completion of study therapy, patients are followed up every 3 months for 1 year.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

39

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

      • Innsbruck, Østrig, A-6020
        • Rekruttering
        • Innsbruck Universitaetsklinik
        • Kontakt:

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:

  • Diagnosis of endometrial carcinoma, including any of the following cellular types:

    • Mixed Mullerian carcinoma
    • Serous carcinoma
    • Clear cell carcinoma
  • Primary advanced (FIGO stage III or stage IV) or metastatic recurrent disease
  • Disease not curable by surgery
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm with x-ray, physical exam, or non-spiral CT scan OR ≥ 10 mm with spiral CT scan or MRI
  • No known cerebral metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 12 weeks
  • Platelet count ≥ 100,000/mm^3
  • ANC ≥ 1,500/mm^3
  • Hemoglobin ≥ 10 g/dL
  • Creatinine ≤ 1.25 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.25 times ULN
  • AST/ALT < 3 times ULN
  • Glomerular filtration rate ≥ 50 mL/min
  • LVEF ≥ 50% by ECHO
  • Fertile patients must use effective contraception
  • No myocardial infarction within the past 6 months
  • No NYHA class II-IV congestive heart failure
  • No third degree or complete heart block unless a pacemaker is in place
  • No other malignancy within the past 5 years
  • No concomitant medical illness (e.g., uncontrolled infection, uncontrolled angina, or other relevant illness) that makes the prescribed treatments within this study unfeasible
  • No known hypersensitivity to study drugs
  • No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy for disease recurrence
  • At least 12 months since prior adjuvant therapy containing anthracyclines with cumulative doses not exceeding the following:

    • Epirubicin 600 mg/m²
    • Doxorubicin 300 mg/m²
  • At least 6 months since prior adjuvant therapy containing platinum
  • At least 4 weeks since completion of radiotherapy involving the whole pelvis
  • No concurrent radiotherapy or planned radiotherapy after study
  • No concurrent endocrine, immunological, or other anticancer therapy
  • No concurrent participation in another investigational drug study

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
  • Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Svarprocent

Sekundære resultatmål

Resultatmål
Samlet overlevelse
Sikkerhed
Gennemførlighed
Varighed af progressionsfri overlevelse

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Studiestol: Christian Marth, MD, PhD, Medical University Innsbruck

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. november 2007

Primær færdiggørelse (Forventet)

1. oktober 2010

Datoer for studieregistrering

Først indsendt

7. april 2010

Først indsendt, der opfyldte QC-kriterier

7. april 2010

Først opslået (Skøn)

8. april 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. august 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. august 2013

Sidst verificeret

1. februar 2011

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 .

Kliniske forsøg med Endometriecancer

Kliniske forsøg med carboplatin

Abonner