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S0355 Ixabepilone in Treating Patients With Advanced Solid Tumors or Lymphomas and Liver Dysfunction

1. april 2015 oppdatert av: Southwest Oncology Group

A Phase I Pharmacokinetic Study Of Epothilone B Analogue BMS-247550 (NSC 710428D) In Patients With Advanced Malignancies And Varying Levels Of Liver Dysfunction

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase I trial is studying the side effects and best dose of ixabepilone in treating patients with advanced solid tumors or lymphomas and liver dysfunction.

Studieoversikt

Detaljert beskrivelse

OBJECTIVES:

  • Determine the levels of hepatic impairment at which dose modifications of ixabepilone are required in patients with advanced solid tumors or lymphomas and varying levels of liver dysfunction.
  • Determine the effect of hepatic dysfunction on the plasma pharmacokinetics of this drug in these patients.
  • Determine the toxic effects of this drug at varying levels of hepatic dysfunction in these patients.

OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to liver function (normal vs mild dysfunction vs moderate dysfunction vs severe dysfunction).

Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, at least 6 but no more than 12 patients are treated at the recommended phase II dose.

Patients are followed for 30 days.

PROJECTED ACCRUAL: A total of 12-84 patients (6-12 for stratum 1; 2-18 for stratum 2; 2-24 for stratum 3; and 2-30 for stratum 4) will be accrued for this study within 12 months.

Studietype

Intervensjonell

Registrering (Faktiske)

78

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • California
      • Duarte, California, Forente stater, 91010-3000
        • City of Hope Comprehensive Cancer Center
      • Los Angeles, California, Forente stater, 90089-9181
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Sacramento, California, Forente stater, 95817
        • University of California Davis Cancer Center
    • Illinois
      • Maywood, Illinois, Forente stater, 60153
        • Cardinal Bernardin Cancer Center at Loyola University Medical Center
    • Kansas
      • Kansas City, Kansas, Forente stater, 66160-7357
        • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
    • Ohio
      • Cleveland, Ohio, Forente stater, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Cleveland, Ohio, Forente stater, 44106
        • Case Comprehensive Cancer Center
      • Independence, Ohio, Forente stater, 44131
        • Community Oncology Group at Cleveland Clinic Cancer Center
      • Wooster, Ohio, Forente stater, 44691
        • Cleveland Clinic - Wooster
    • Texas
      • Fort Sam Houston, Texas, Forente stater, 78234
        • Brooke Army Medical Center
      • Lackland AFB, Texas, Forente stater, 78236
        • Wilford Hall Medical Center
      • San Antonio, Texas, Forente stater, 78229-3900
        • University of Texas Health Science Center at San Antonio
    • Washington
      • Bellingham, Washington, Forente stater, 98225
        • St. Joseph Hospital Community Cancer Center
      • Bremerton, Washington, Forente stater, 98310
        • Olympic Hematology and Oncology
      • Mt. Vernon, Washington, Forente stater, 98273
        • Skagit Valley Hospital Cancer Care Center
      • Seattle, Washington, Forente stater, 98104
        • Harborview Medical Center
      • Seattle, Washington, Forente stater, 98104
        • Fred Hutchinson Cancer Research Center
      • Seattle, Washington, Forente stater, 98122-4307
        • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
      • Seattle, Washington, Forente stater, 98195-6043
        • University Cancer Center at University of Washington Medical Center
      • Seattle, Washington, Forente stater, 98104-1387
        • Group Health Central Hospital
      • Sedro-Wooley, Washington, Forente stater, 98284
        • North Puget Oncology at United General Hospital
      • Spokane, Washington, Forente stater, 99202
        • Cancer Care Northwest - Spokane South
      • Wenatchee, Washington, Forente stater, 98801-2028
        • Wenatchee Valley Medical Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed solid tumor or lymphoma for which standard curative or palliative measures do not exist or are no longer effective

    • Pathological confirmation of diagnosis not required in patients with liver mass, raised alpha-fetoprotein levels (at least 500 ng/mL), and positive serology for hepatitis consistent with a diagnosis of hepatocellular carcinoma
    • Any solid tumor or lymphoma tumor type eligible
    • Must have had thoracic and upper abdominal CT scan, including entire liver and adrenals, within 28 days before study entry
  • Patients with glioma or brain metastases must be on a stable dose of corticosteroids and be seizure-free for the past month

    • Prior whole brain or gamma knife radiotherapy required for known brain metastases
    • No unstable or untreated (non-irradiated) brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • No active hemolysis

Hepatic

  • See Disease Characteristics
  • Patients with biliary obstruction for which a shunt has been placed are allowed if shunt is in place for at least 10 days and liver function is stable
  • Abnormal liver function (bilirubin and SGOT) allowed regardless of cause (metastases or other causes)
  • No evidence of biliary sepsis

Renal

  • Creatinine no greater than 1.5 mg/dL

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other

  • No concurrent uncontrolled illness
  • No ongoing or active infection
  • No uncontrolled diarrhea
  • No peripheral neuropathy grade II or greater
  • No psychiatric illness or social situation that would preclude study compliance
  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent immunotherapy for malignancy

Chemotherapy

  • More than 2 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • No other concurrent chemotherapy for malignancy

Endocrine therapy

  • See Disease Characteristics
  • No concurrent oral contraceptives
  • No concurrent hormone therapy for malignancy

    • Concurrent luteinizing hormone-releasing hormone agonists allowed

Radiotherapy

  • See Disease Characteristics
  • More than 4 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy for malignancy

Surgery

  • More than 2 weeks since prior major surgery

Other

  • Recovered from prior therapy
  • No concurrent medications that are known to be inhibitors of CYP3A4

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: treatment
Single-arm, dose-escalation of BMS-247550
BMS-247550 as a 3-hour infusion on Day 1 of a three-week cycle

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
dose defining
Tidsramme: Treatment delays >2 weeks constitute a DLT
Treatment delays >2 weeks constitute a DLT

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression
Tidsramme: 30 days after going off study
20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline.
30 days after going off study
Symptomatic deterioration
Tidsramme: 30 days after going off study
Global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.
30 days after going off study

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Samarbeidspartnere

Etterforskere

  • Hovedetterforsker: Chris H. Takimoto, MD, PhD, Institute for Drug Development

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

  • Takimoto CH, Liu PY, Lenz H, et al.: A phase I pharmacokinetic (PK) study of the epothilone B analogue, ixabepilone (BMS-247550) in patients (pts) with advanced malignancies and varying degrees of hepatic impairment. A SWOG Early Therapeutics Committee and NCI Organ Dysfunction Working Group Trial. [Abstract] J Clin Oncol 24 (Suppl 18): A-2004, 2006.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2003

Primær fullføring (Faktiske)

1. september 2006

Studiet fullført (Faktiske)

1. desember 2007

Datoer for studieregistrering

Først innsendt

12. november 2002

Først innsendt som oppfylte QC-kriteriene

26. januar 2003

Først lagt ut (Anslag)

27. januar 2003

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

3. april 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. april 2015

Sist bekreftet

1. april 2015

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • S0355 (Annen identifikator: SWOG)
  • U10CA032102 (U.S. NIH-stipend/kontrakt)
  • P30CA016087 (U.S. NIH-stipend/kontrakt)
  • U01CA076642 (U.S. NIH-stipend/kontrakt)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på BMS-247550

3
Abonnere