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

1. april 2015 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

78

Fase

  • Fase 1

Kontakter og lokationer

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

Studiesteder

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

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 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

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
Eksperimentel: treatment
Single-arm, dose-escalation of BMS-247550
Medicin: BMS-247550
BMS-247550 as a 3-hour infusion on Day 1 of a three-week cycle

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

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

Sponsor

Southwest Oncology Group

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

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

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.

Generelle publikationer

  • 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.

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. oktober 2003

Primær færdiggørelse (Faktiske)

1. september 2006

Studieafslutning (Faktiske)

1. december 2007

Datoer for studieregistrering

Først indsendt

12. november 2002

Først indsendt, der opfyldte QC-kriterier

26. januar 2003

Først opslået (Skøn)

27. januar 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

3. april 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. april 2015

Sidst verificeret

1. april 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

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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