- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00334893
Eribulin Mesylate in Treating Patients With Recurrent Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer
A Multi-Center Phase II Study of the Halichondrin B Analog E7389 in Recurrent Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
PRIMARY OBJECTIVES:
I. Determine the frequency of objective response (complete and partial responses) in patients with recurrent ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer treated with E7389 (eribulin mesylate).
SECONDARY OBJECTIVES:
II. Determine the toxicity profile of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to prior platinum sensitivity (yes vs no).
Patients receive eribulin mesylate intravenously (IV) over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 4 weeks.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02115
- Dana-Farber Cancer Institute
-
-
New York
-
New York, New York, Forenede Stater, 10065
- Memorial Sloan-Kettering Cancer Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
Histologically or cytologically confirmed ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer
Recurrent disease after ≥ 1 prior therapy, meeting 1 of the following criteria:
- Platinum-resistant disease (progression-free interval < 6 months)
- Platinum-sensitive disease (progression-free interval ≥ 6 months)
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mmby conventional techniques OR ≥ 10 mm by spiral CT scan
- No known brain metastasis
- Life expectancy > 2 months
- ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- WBC ≥ 3,000/mm^3
- Bilirubin normal
- AST and ALT ≤ 2.5 times upper limit of normal
- Creatine normal OR creatinine clearance ≥ 60 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
No prior invasive malignancy within the past 5 years except nonmelanoma skin cancer
- Stage IA or IB endometrial cancer within the past 5 years allowed provided patient is considered disease free
- No history of allergic reaction attributed to compounds of similar chemical or biological composition to E7389
- No HIV positivity
- No ongoing or active infection
- No cardiac arrhythmia
- No unstable angina pectoris
- No symptomatic congestive heart failure
- No psychiatric illness or social situations that would preclude study compliance
- No other uncontrolled intercurrent illness
- See Disease Characteristics
- Recovered from effects of recent surgery, radiotherapy, or chemotherapy
- No more than 2 prior cytotoxic therapies with no more than 1 non platinum, non taxane regimen
- No prior E7389
- More than 14 days since prior hormonal therapy
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
- More than 4 weeks since prior radiotherapy
- No concurrent antitumor hormonal therapy
- No other concurrent investigational agents
- No other concurrent anticancer agents or therapies
- No granulocyte colony-stimulating factors during the first course of study therapy
Studieplan
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 |
|---|---|
|
Eksperimentel: Treatment (chemotherapy)
Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Givet IV
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Objective Response to Treatment With Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer.
Tidsramme: up to a total of a year
|
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
|
up to a total of a year
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Toxicity Profile of Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer
Tidsramme: From the time of their first treatment with eribulin mesylate
|
Measured by NCI CTCAE Version 4.0.
The 95% confidence intervals should be provided.
Please see adverse events.
|
From the time of their first treatment with eribulin mesylate
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Martee Hensley, Memorial Sloan Kettering Cancer Center
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Neoplasmer efter histologisk type
- Neoplasmer
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Karcinom
- Neoplasmer, kirtel og epitel
- Genitale neoplasmer, kvindelige
- Sygdomme i det endokrine system
- Sygdomsegenskaber
- Ovariesygdomme
- Adnexale sygdomme
- Gonadale lidelser
- Neoplasmer i endokrine kirtler
- Æggeledersygdomme
- Ovariale neoplasmer
- Tilbagevenden
- Æggelederneoplasmer
- Karcinom, ovarieepitel
Andre undersøgelses-id-numre
- NCI-2009-00169 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- P30CA008748 (U.S. NIH-bevilling/kontrakt)
- N01CM62206 (U.S. NIH-bevilling/kontrakt)
- MSKCC-06027
- NCI-7431
- CDR0000481534
- 06-027 (Anden identifikator: Memorial Sloan-Kettering Cancer Center)
- 7431 (Anden identifikator: CTEP)
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