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BMS-247550 in Treating Women With Metastatic Breast Cancer

17. juni 2013 opdateret af: Memorial Sloan Kettering Cancer Center

A Phase II Study of Epothilone B Analog BMS-247550 in Patients With Taxane-Resistant Metastatic Breast Cancer

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

PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating women who have stage IV or recurrent metastatic breast cancer.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

  • Determine the clinical activity of BMS-247550, in terms of tumor response rate, in women with taxane-resistant metastatic breast cancer.
  • Determine the safety of this drug in these patients.
  • Determine the duration of response, time to progression, and survival of patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive BMS-247550 IV over 3 hours on day 1. Treatment continues every 3 weeks for 4-18 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 4 additional courses beyond CR. Responding patients may receive additional courses at the investigator's discretion.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 14-50 patients will be accrued for this study within 12 months.

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

    • New York
      • New York, New York, Forenede Stater, 10021
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, Forenede Stater, 10032
        • Herbert Irving Comprehensive Cancer 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

Kvinde

Beskrivelse

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed metastatic breast carcinoma

    • Stage IV or recurrent disease with distant metastases
  • Most recent prior chemotherapy was docetaxel-based or paclitaxel-based therapy for metastatic disease

    • Progressed during therapy or within 4 months of last dose OR
    • Progressed during therapy or within 6 months of last dose if given as adjuvant treatment only
  • Received prior anthracycline therapy
  • Bidimensionally measurable metastatic lesion

    • Bony lesions not considered measurable
  • No known brain metastases
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Menopausal status:

  • Not specified

Sex:

  • Female

Performance status:

  • ECOG 0-1

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • Absolute neutrophil count at least 2,000/mm^3
  • Platelet count greater than 125,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • ALT no greater than 2.5 times ULN (5 times ULN if hepatic metastases are present)

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • No unstable angina, myocardial infarction, or congestive heart failure within the past 6 months

Other:

  • No grade 2 or greater neuropathy (motor or sensory)
  • No uncontrolled infection or other medical illness that would preclude study
  • No psychiatric disorder or other condition that would preclude study
  • No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No hypersensitivity to agents containing Cremophor EL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 24 hours since prior growth factor
  • No concurrent trastuzumab (Herceptin)
  • No concurrent immunotherapy

Chemotherapy:

  • See Disease Characteristics
  • No more than 1 prior chemotherapy regimen for metastatic disease except an anthracycline-containing regimen as first-line therapy and a taxane as second-line therapy
  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent hormonal therapy (except hormone replacement therapy)

Radiotherapy:

  • At least 3 weeks since prior radiotherapy, except palliative radiotherapy to less than 20% of the bone marrow, and recovered
  • No prior radiotherapy to major bone marrow-containing areas (pelvis and lumbar spine)
  • No prior radiotherapy to target lesion if only measurable lesion
  • No concurrent therapeutic radiotherapy

Surgery:

  • At least 1 week since prior minor surgery
  • At least 3 weeks since prior major surgery
  • Recovered from prior surgery

Other:

  • Recovered from all prior treatment-related toxic effects (alopecia allowed)
  • No other concurrent experimental anticancer medications

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.

Samarbejdspartnere

Efterforskere

  • Studiestol: Clifford A. Hudis, MD, Memorial Sloan Kettering Cancer Center

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. januar 2003

Studieafslutning (Faktiske)

1. januar 2003

Datoer for studieregistrering

Først indsendt

11. juli 2001

Først indsendt, der opfyldte QC-kriterier

9. september 2003

Først opslået (Skøn)

10. september 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

18. juni 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. juni 2013

Sidst verificeret

1. juni 2013

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 01-031
  • CDR0000068729 (Registry Identifier: PDQ (Physician Data Query))
  • BMS-CA163-009
  • CPMC-IRB-13916
  • NCI-G01-1967

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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