- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00049400
S0355 Ixabepilone in Treating Patients With Advanced Solid Tumors or Lymphomas and Liver Dysfunction
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
Status
Intervensjon / Behandling
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
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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California
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Duarte, California, Forente stater, 91010-3000
- City of Hope Comprehensive Cancer Center
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Los Angeles, California, Forente stater, 90089-9181
- USC/Norris Comprehensive Cancer Center and Hospital
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Sacramento, California, Forente stater, 95817
- University of California Davis Cancer Center
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Illinois
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Maywood, Illinois, Forente stater, 60153
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
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Kansas
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Kansas City, Kansas, Forente stater, 66160-7357
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
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Ohio
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Cleveland, Ohio, Forente stater, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, Forente stater, 44106
- Case Comprehensive Cancer Center
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Independence, Ohio, Forente stater, 44131
- Community Oncology Group at Cleveland Clinic Cancer Center
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Wooster, Ohio, Forente stater, 44691
- Cleveland Clinic - Wooster
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Texas
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Fort Sam Houston, Texas, Forente stater, 78234
- Brooke Army Medical Center
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Lackland AFB, Texas, Forente stater, 78236
- Wilford Hall Medical Center
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San Antonio, Texas, Forente stater, 78229-3900
- University of Texas Health Science Center at San Antonio
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Washington
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Bellingham, Washington, Forente stater, 98225
- St. Joseph Hospital Community Cancer Center
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Bremerton, Washington, Forente stater, 98310
- Olympic Hematology and Oncology
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Mt. Vernon, Washington, Forente stater, 98273
- Skagit Valley Hospital Cancer Care Center
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Seattle, Washington, Forente stater, 98104
- Harborview Medical Center
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Seattle, Washington, Forente stater, 98104
- Fred Hutchinson Cancer Research Center
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Seattle, Washington, Forente stater, 98122-4307
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
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Seattle, Washington, Forente stater, 98195-6043
- University Cancer Center at University of Washington Medical Center
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Seattle, Washington, Forente stater, 98104-1387
- Group Health Central Hospital
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Sedro-Wooley, Washington, Forente stater, 98284
- North Puget Oncology at United General Hospital
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Spokane, Washington, Forente stater, 99202
- Cancer Care Northwest - Spokane South
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Wenatchee, Washington, Forente stater, 98801-2028
- Wenatchee Valley Medical Center
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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:
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
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
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BMS-247550 as a 3-hour infusion on Day 1 of a three-week cycle
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
dose defining
Tidsramme: Treatment delays >2 weeks constitute a DLT
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Treatment delays >2 weeks constitute a DLT
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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.
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30 days after going off study
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Symptomatic deterioration
Tidsramme: 30 days after going off study
|
Global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.
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30 days after going off study
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Chris H. Takimoto, MD, PhD, Institute for Drug Development
Publikasjoner og nyttige lenker
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
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
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
- uspesifisert voksen solid svulst, protokollspesifikk
- stadium IV voksent immunoblastisk storcellet lymfom
- tilbakevendende voksent diffust storcellet lymfom
- tilbakevendende immunoblastisk storcellet lymfom hos voksne
- tilbakevendende voksen Burkitt lymfom
- tilbakevendende voksen Hodgkin lymfom
- tilbakevendende voksent diffust små spaltet celle lymfom
- tilbakevendende voksent diffust blandet celle lymfom
- stadium IV voksent diffust små spaltet celle lymfom
- stadium IV mantelcellelymfom
- tilbakevendende marginalsone lymfom
- tilbakevendende små lymfatiske lymfomer
- stadium IV små lymfatiske lymfomer
- stadium IV marginal sone lymfom
- nodal marginal sone B-celle lymfom
- milt marginal sone lymfom
- tilbakevendende lymfoblastisk lymfom hos voksne
- tilbakevendende mantelcellelymfom
- stadium IV kutant T-celle non-Hodgkin lymfom
- tilbakevendende kutant T-celle non-Hodgkin lymfom
- tynntarms lymfom
- stadium IV voksen lymfatisk lymfom
- stadium IV voksen T-celle leukemi/lymfom
- tilbakevendende voksen T-celle leukemi/lymfom
- intraokulært lymfom
- angioimmunoblastisk T-celle lymfom
- anaplastisk storcellet lymfom
- primær lymfom i sentralnervesystemet
- recurrent grade 1, 2, or 3 follicular lymphoma
- stage IV adult diffuse large cell or mixed cell lymphoma
- stage IV adult Burkitt lymphoma or Hodgkin lymphoma
- stage IV grade 1, 2, or 3 follicular lymphoma
- extranodal marginal zone B-cell lymphoma of MALT
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Sykdommer i immunsystemet
- Neoplasmer etter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Lymfesykdommer
- Immunproliferative lidelser
- Neoplasmer etter nettsted
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Tarmsykdommer
- Leversykdommer
- Lymfom
- Intestinale neoplasmer
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)
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