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Weekly Infusions of Paclitaxel in Treating Women With Stage III or Stage IV Ovarian Cancer Refractory to Paclitaxel and Platinum

19. april 2011 oppdatert av: Theradex

A Phase II Trial of Paclitaxel (Taxol) Administered as a Weekly One Hour Infusion in Patients With Taxol/Platinum-Refractory Stage III and IV Ovarian Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different ways may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating women with stage III or stage IV ovarian cancer that is refractory to paclitaxel and platinum-based regimens.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

OBJECTIVES: I. Determine the objective response rate of paclitaxel given as a weekly one hour infusion in patients with paclitaxel/platinum refractory stage III and IV ovarian cancer. II. Evaluate the safety of paclitaxel in this patient population. III. Assess the overall survival in these patients. IV. Assess quality of life in these patients.

OUTLINE: This is a multicenter, open label, nonrandomized study. Patients are administered paclitaxel as a one hour IV infusion every 7 days. Each cycle consists of four weeks. Treatment may be delayed for up to 2 weeks and there is no limit to the number of interruptions a patient may experience. Patients receive paclitaxel weekly until disease progression or unacceptable toxicity. Treatment is assessed every 3 cycles for one year and then every 6 months thereafter during study. Quality of life is assessed every cycle for the first 6 cycles, then every 3 cycles thereafter. Patients are followed every 3 months for survival.

PROJECTED ACCRUAL: There will be 100 patients accrued into this study.

Studietype

Intervensjonell

Registrering (Forventet)

100

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • Alabama
      • Mobile, Alabama, Forente stater, 36608
        • Oncology Center at Providence Park
    • Arizona
      • Phoenix, Arizona, Forente stater, 85013
        • Hematology Associates, Ltd.
    • Arkansas
      • Fayetteville, Arkansas, Forente stater, 72703
        • Highlands Oncology Group, P.A.
    • California
      • Santa Barbara, California, Forente stater, 93105
        • Cancer Center of Santa Barbara
    • Florida
      • West Palm Beach, Florida, Forente stater, 33401
        • Good Samaritan Medical Center
    • Illinois
      • Decatur, Illinois, Forente stater, 62526
        • Decatur Memorial Hospital Cancer Care Institute
    • Nebraska
      • Omaha, Nebraska, Forente stater, 68131-2197
        • Creighton University Cancer Center
    • New Jersey
      • Neptune, New Jersey, Forente stater, 07753
        • Jersey Shore Cancer Center
    • New York
      • Albany, New York, Forente stater, 12209
        • Women's Health Center at Albany Medical Center
    • North Carolina
      • Charlotte, North Carolina, Forente stater, 28232-2861
        • Carolinas Medical Center
    • Ohio
      • Akron, Ohio, Forente stater, 44302
        • Akron General Medical Center
      • Cincinnati, Ohio, Forente stater, 45219
        • Oncology/Hematology Care, Inc.
      • Cleveland, Ohio, Forente stater, 44195
        • Cleveland Clinic Cancer Center
    • Pennsylvania
      • Harrisburg, Pennsylvania, Forente stater, 17105-8700
        • Women's Cancer Center of Central PA, P.C.
    • Rhode Island
      • Providence, Rhode Island, Forente stater, 02905
        • Women and Infants Hospital of Rhode Island
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37203
        • Brookview Research, Inc.
    • Texas
      • Amarillo, Texas, Forente stater, 79106
        • Harrington Cancer Center
    • Washington
      • Spokane, Washington, Forente stater, 99202
        • Rockwood Clinic P.S.

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

Hunn

Beskrivelse

DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV ovarian cancer that is refractory to an initial chemotherapy regimen that included a platinum agent plus paclitaxel - Epithelial ovarian cancer - Primary carcinoma of the peritoneum - Fallopian tube cancer Initial response to platinum and paclitaxel must have been one of the following: Progression or stable disease Response that lasted less than 3 months Response that lasted at least 3 months, but when retreated with both agents (in combination or as single agents) disease was refractory Measurable or evaluable disease Evaluable disease is defined by: CA-125 at least 100 units/mL AND CA-125 level must have at least doubled from baseline determination

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) AST or ALT no greater than 2.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No New York Heart Association Class III or IV heart disease No myocardial infarction within last 6 months No congestive heart failure No unstable angina No clinically significant pericardial effusion or arrhythmia Neurology: No current peripheral neuropathy of any etiology that is greater than grade 1 Other: No active serious infection or other serious underlying medical condition No prior significant allergic reactions to drugs containing Cremophor, such as teniposide, cyclosporin, or vitamin K Not pregnant or nursing Adequate contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since immunotherapy No concurrent immunotherapy Chemotherapy: Prior paclitaxel treatment must have been administered on a 3 week or greater schedule No other prior chemotherapy besides platinum and paclitaxel At least 3 weeks since acceptable chemotherapy Endocrine therapy: At least 3 weeks since hormonal therapy No concurrent hormonal therapy Radiotherapy: At least 3 weeks since radiotherapy No prior radiation to greater than 30% of bone marrow Surgery: At least 3 weeks since major surgery

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling

Samarbeidspartnere og etterforskere

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

Sponsor

Theradex

Etterforskere

  • Studiestol: Maurie Markman, MD, The Cleveland Clinic

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. september 1997

Datoer for studieregistrering

Først innsendt

1. november 1999

Først innsendt som oppfylte QC-kriteriene

26. mai 2004

Først lagt ut (Anslag)

27. mai 2004

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

20. april 2011

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. april 2011

Sist bekreftet

1. januar 2001

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CDR0000065955
  • THERADEX-B97-3250
  • BMS-TAX/MEN.03
  • NCI-V97-1366

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. .

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