Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

UCN-01 and Topotecan in Treating Patients With Recurrent, Persistent, or Progressive Advanced Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

22. juli 2015 oppdatert av: University Health Network, Toronto

A Phase II Study of UCN-01 in Combination With Topotecan in Patients With Advanced Ovarian Cancer

RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining UCN-01 with topotecan may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining UCN-01 with topotecan in treating patients who have recurrent, persistent, or progressive advanced ovarian epithelial, primary peritoneal, or fallopian tube cancer.

Studieoversikt

Detaljert beskrivelse

OBJECTIVES:

Primary

  • Determine the antitumor activity of UCN-01 and topotecan, in terms of complete and partial objective response rates, in patients with recurrent, persistent, or progressive advanced ovarian epithelial, primary peritoneal, or fallopian tube cancer.

Secondary

  • Determine the antitumor activity of this regimen, in terms of stable disease rates and duration of response, in these patients.
  • Determine the progression-free, median, and overall survival of patients treated with this regimen.
  • Determine the safety and tolerability of this regimen in these patients.
  • Determine the relationship between clinical and pharmacodynamic effects of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive UCN-01 IV over 3 hours on day 1 and topotecan IV over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 19-33 patients will be accrued for this study within 5-11 months.

Studietype

Intervensjonell

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiesteder

    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Margaret and Charles Juravinski Cancer Centre
      • London, Ontario, Canada, N6A 4L6
        • Cancer Care Ontario-London Regional Cancer Centre
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Regional Cancer Centre
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital

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 or cytologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer

    • Progressive, persistent, or recurrent disease
  • Measurable disease outside prior radiotherapy field unless disease progression occurred after radiotherapy
  • Tumor lesions accessible for biopsy

    • Patients with a medical contraindication to tumor biopsy may be allowed at the discretion of the principal investigator
  • No more than 2 prior chemotherapy regimens

    • At least 1 regimen must have contained a platinum agent (i.e., carboplatin or cisplatin)
  • No known brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • More than 12 weeks

Hematopoietic

  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin no greater than upper limit of normal (ULN)
  • AST/ALT no greater than 2.5 times ULN

Renal

  • Creatinine no greater than ULN OR
  • Creatinine clearance at least 50 mL/min

Cardiovascular

  • No history of coronary artery disease
  • No symptomatic cardiac dysfunction
  • No cardiac pathology by electrocardiogram* NOTE: *Patients with symptomatic coronary artery disease must undergo an electrocardiogram

Pulmonary

  • No symptomatic pulmonary dysfunction

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 8 weeks after study participation
  • No prior allergic reaction attributed to compounds of similar chemical or biological composition to UCN-01 or other study agents
  • No insulin-dependent diabetes mellitus

    • Diabetes controlled by diet or oral hypoglycemic agents allowed at the discretion of the investigator
  • No other concurrent uncontrolled illness
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 4 weeks since prior biologic therapy and recovered

Chemotherapy

  • See Disease Characterisitcs
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • No prior topotecan
  • No other prior topoisomerase I inhibitors

Endocrine therapy

  • More than 4 weeks since prior hormonal therapy and recovered

Radiotherapy

  • See Disease Characteristics
  • More than 4 weeks since prior radiotherapy and recovered
  • No prior radiotherapy to more than 40% of bone marrow
  • No prior mediastinal irradiation

Surgery

  • More than 4 weeks since prior surgery and recovered

Other

  • No other concurrent anticancer therapy
  • No other concurrent investigational agents
  • No concurrent combination antiretroviral therapy for HIV-positive patients

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Masking: Ingen (Open Label)

Samarbeidspartnere og etterforskere

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

Samarbeidspartnere

Etterforskere

  • Hovedetterforsker: Hal W. Hirte, MD, FRCP(C), Margaret and Charles Juravinski Cancer Centre

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. januar 2004

Primær fullføring (Faktiske)

1. april 2005

Datoer for studieregistrering

Først innsendt

4. november 2003

Først innsendt som oppfylte QC-kriteriene

5. november 2003

Først lagt ut (Anslag)

6. november 2003

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

23. juli 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. juli 2015

Sist bekreftet

1. juli 2015

Mer informasjon

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. .

Abonnere