- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01100359
Liposome-Encapsulated Doxorubicin Citrate and Carboplatin in Treating Patients With Advanced or Metastatic Recurrent Endometrial Cancer
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.
Studieoversikt
Status
Forhold
Detaljert 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.
Studietype
Registrering (Forventet)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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Innsbruck, Østerrike, A-6020
- Rekruttering
- Innsbruck Universitaetsklinik
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Ta kontakt med:
- Contact Person
- Telefonnummer: 43-512-504-23050
- E-post: Christian.marth@i-med.ac.at
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Masking: Ingen (Open Label)
Hva måler studien?
Primære resultatmål
Resultatmål |
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Svarprosent
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Sekundære resultatmål
Resultatmål |
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Total overlevelse
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Sikkerhet
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Gjennomførbarhet
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Varighet av progresjonsfri overlevelse
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Christian Marth, MD, PhD, Medical University Innsbruck
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Neoplasmer
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Uterine neoplasmer
- Genitale neoplasmer, kvinnelige
- Livmorsykdommer
- Endometriale neoplasmer
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Antineoplastiske midler
- Topoisomerase II-hemmere
- Topoisomerasehemmere
- Antibiotika, antineoplastisk
- Karboplatin
- Doxorubicin
- Liposomal doksorubicin
Andre studie-ID-numre
- MUI-AGO-15
- CDR0000669712 (Registeridentifikator: PDQ (Physician Data Query))
- EUDRACT-2007-004060-40
- EU-21027
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