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A Phase II Study of Epothilone Analog BMS-247550 in Patients With Non-Small Cell Lung Cancer Who Have Failed First Line Platinum Based Chemotherapy

9. februar 2016 opdateret af: R-Pharm
The purpose of this clinical research study is to learn if BMS-247550 can shrink or slow the growth of the cancer in patients with non-small cell lung cancer who have failed first-line platinum based chemotherapy. The safety of this treatment will also be studied.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294
        • University of Alabama at Birmingham
    • California
      • Sacramento, California, Forenede Stater, 958177
        • Un of California Davis Cancer Center
    • Florida
      • Miami Beach, Florida, Forenede Stater, 33140
        • Mount Sinai Medical Center
      • Tampa, Florida, Forenede Stater, 33612
        • H Lee Moffitt Cancer Center
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612-3828
        • Rush Presbyterian St Lukes ME
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40207
        • Consultants in Blood Disorders
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70121
        • Ochsner Cancer Institute
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21201
        • University of Maryland Greenbaum Cancer Center
    • Massachusetts
      • Burlington, Massachusetts, Forenede Stater, 01805
        • Lahey Clinic
    • Missouri
      • Columbia, Missouri, Forenede Stater, 65203
        • University of Missouri/Ellis Fischel Cancer Center
    • New Hampshire
      • Lebanon, New Hampshire, Forenede Stater, 03756
        • Dartmouth-Hitchcock /Norris Cotton Cancer Center
    • New Jersey
      • New Brunswick, New Jersey, Forenede Stater, 08901
        • Cancer Institute Of New Jersey
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27599
        • Unviversity of North Carolina
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37203
        • Sarah Cannon Cancer Center
      • Nashville, Tennessee, Forenede Stater, 37232-5536
        • Vanderbilt University Med School Div of Medical Oncology
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53792
        • University of Wisconsin Hospital

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

Inclusion Criteria:

  • Histologically or cytologically confirmed non-small cell lung cancer
  • Bidimensionally measurable disease
  • Progressed following therapy with one prior cisplatin or carboplatin based chemotherapy regimen for Stage III or IV or metastatic recurrent disease
  • Adequate hematologic function as defined by: absolute neutrophils =/> 2,000/mm3, and platelets > 125,000/mm3
  • Adequate hepatic function as defined by: serum bilirubin=/<1.5 times the upper institutional limits of normal, ALT =/< 2.5 times the upper institutional limits of normal (=/<5 times the upper institutional limits of normal if hepatic metastases are present
  • Adequate renal function as defined: by serum creatine =/< 1.5 times the upper limits of normal
  • Adequate recovery from recent surgery, chemotherapy and radiation therapy. At least one week must have elapsed from the time of a minor surgery, at least 3 weeks for major surgery, chemotherapy and radiation therapy
  • Life expectancy of at least 12 weeks
  • ECOG performance status of 0-1
  • At least 18 years old
  • Willing and able to give written informed consent
  • Accessible for treatment and follow-up. Patients enrolled in this trial must be treated at the participating center
  • Women of Child Bearing Potential (WOCP) must have a negative serum or urine pregnancy test (minimum sensitivity IU/L or equivalent units of HCG) within 72 hours prior to start of study medication.

WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea=/>12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level > 35mIU/mL]. Even women who are using oral, implanted or, injectable intrauterine device or barrier methods (diaphragm, condoms, spermicide) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential.

Exclusion Criteria

  • More than one prior chemotherapy regimen for Stage IIIB or IV or for metastatic recurrent disease. Prior adjuvant or neoadjuvant chemotherapy is allowed.
  • Patients who are candidates for curative resection.
  • CTC Grade 2 or greater neuropathy (motor or sensory)
  • Known brain metastases
  • Prior radiation must have not included major bone marrow containing areas (pelvis, lumbar, spine) and must not have contained a target lesion as the only measurable lesion. A recovery period of at least 3 weeks after completion of radiotherapy is required prior to enrollment.
  • Myocardial infarction, unstable angina, or any history of congestive heart failure within six months of study therapy
  • Pregnant or breast-feeding women, or sexually active women of childbearing potential not using an adequate method of birth control.
  • Sexually active fertile men, whose partners are women of childbearing potential, unless using an adequate method of birth control
  • Serious intercurrent infections, or nonmalignant medical illnesses that are controlled or whose control may be jeopardized by the complications of this therapy
  • Psychiatric disorders or other conditions rendering the patient incapable of complying with the requirements of the the protocol

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

Samarbejdspartnere og efterforskere

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

Sponsor

R-Pharm

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

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. februar 2001

Primær færdiggørelse (Faktiske)

1. april 2004

Studieafslutning (Faktiske)

1. april 2004

Datoer for studieregistrering

Først indsendt

3. maj 2002

Først indsendt, der opfyldte QC-kriterier

3. maj 2002

Først opslået (Skøn)

6. maj 2002

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

10. februar 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. februar 2016

Sidst verificeret

1. februar 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CA163-011

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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