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Topotecan in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

27. juni 2018 opdateret af: Gynecologic Oncology Group

A Randomized Phase II Evaluation of Topotecan (NSC #609699) Administered Daily x 5 Every 3 Weeks vs Weekly Topotecan in the Treatment of Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving topotecan in different dosing schedules may kill more tumor cells.

PURPOSE: This phase II trial is studying how well topotecan works in treating patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

Primary

  • Determine the antitumor activity of topotecan, in terms of frequency and duration of tumor response, in patients with recurrent platinum-sensitive ovarian epithelial, fallopian tube, or primary peritoneal cancer.
  • Determine the nature and degree of toxicity of this regimen in these patients.

Secondary

  • Determine the duration of progression-free survival and overall survival in patients treated with these regimens.
  • Determine the effects of prognostic variables (i.e., initial performance status, age, and mucinous or clear cell histology) in patients treated with these regimens.

OUTLINE: This is a multicenter study.

Patients receive topotecan IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: Approximately 38-110 patients (19-55 per treatment arm) will be accrued for this study within 15-30 months.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

81

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
    • Connecticut
      • Hartford, Connecticut, Forenede Stater, 06105
        • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
      • New Britain, Connecticut, Forenede Stater, 06050
        • George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
    • Delaware
      • Lewes, Delaware, Forenede Stater, 19958
        • Tunnell Cancer Center at Beebe Medical Center
      • Newark, Delaware, Forenede Stater, 19713
        • CCOP - Christiana Care Health Services
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20010
        • Washington Cancer Institute at Washington Hospital Center
    • Georgia
      • Augusta, Georgia, Forenede Stater, 30912
        • MBCCOP - Medical College of Georgia Cancer Center
    • Illinois
      • Aurora, Illinois, Forenede Stater, 60507
        • Rush-Copley Cancer Care Center
      • Chicago, Illinois, Forenede Stater, 60612
        • Rush University Medical Center
      • Chicago, Illinois, Forenede Stater, 60612-7243
        • University of Illinois Cancer Center
      • Hinsdale, Illinois, Forenede Stater, 60521
        • Hinsdale Hematology Oncology Associates
      • Joliet, Illinois, Forenede Stater, 60435
        • Joliet Oncology-Hematology Associates, Limited - West
      • Park Ridge, Illinois, Forenede Stater, 60068-1174
        • Advocate Lutheran General Cancer Care Center
      • Urbana, Illinois, Forenede Stater, 61801
        • Carle Cancer Center at Carle Foundation Hospital
      • Urbana, Illinois, Forenede Stater, 61801
        • CCOP - Carle Cancer Center
    • Indiana
      • Michigan City, Indiana, Forenede Stater, 46360
        • Saint Anthony Memorial Health Centers
    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52242-1002
        • Holden Comprehensive Cancer Center at University of Iowa
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70815
        • Woman's Hospital
    • Maryland
      • Elkton, Maryland, Forenede Stater, 21921
        • Union Hospital Cancer Program at Union Hospital
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02111
        • Tufts-NEMC Cancer Center
      • Worcester, Massachusetts, Forenede Stater, 01655
        • UMASS Memorial Cancer Center - University Campus
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48106-0995
        • Saint Joseph Mercy Cancer Center
      • Ann Arbor, Michigan, Forenede Stater, 48106
        • CCOP - Michigan Cancer Research Consortium
      • Dearborn, Michigan, Forenede Stater, 48123-2500
        • Oakwood Cancer Center at Oakwood Hospital and Medical Center
      • Flint, Michigan, Forenede Stater, 48503
        • Hurley Medical Center
      • Flint, Michigan, Forenede Stater, 48503
        • Genesys Hurley Cancer Institute
      • Grosse Pointe Woods, Michigan, Forenede Stater, 48236
        • Van Elslander Cancer Center at St. John Hospital and Medical Center
      • Jackson, Michigan, Forenede Stater, 49201
        • Foote Memorial Hospital
      • Kalamazoo, Michigan, Forenede Stater, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, Forenede Stater, 49001
        • Borgess Medical Center
      • Kalamazoo, Michigan, Forenede Stater, 49007-3731
        • West Michigan Cancer Center
      • Lansing, Michigan, Forenede Stater, 48912-1811
        • Sparrow Regional Cancer Center
      • Livonia, Michigan, Forenede Stater, 48154
        • St. Mary Mercy Hospital
      • Pontiac, Michigan, Forenede Stater, 48341-2985
        • St. Joseph Mercy Oakland
      • Port Huron, Michigan, Forenede Stater, 48060
        • Mercy Regional Cancer Center at Mercy Hospital
      • Royal Oak, Michigan, Forenede Stater, 48073
        • William Beaumont Hospital - Royal Oak Campus
      • Saginaw, Michigan, Forenede Stater, 48601
        • Seton Cancer Institute at Saint Mary's - Saginaw
      • Warren, Michigan, Forenede Stater, 48093
        • St. John Macomb Hospital
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39216
        • University of Mississippi Cancer Clinic
    • Missouri
      • Saint Louis, Missouri, Forenede Stater, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
      • Saint Louis, Missouri, Forenede Stater, 63110
        • Saint Louis University Cancer Center
      • Springfield, Missouri, Forenede Stater, 65802
        • CCOP - Cancer Research for the Ozarks
      • Springfield, Missouri, Forenede Stater, 65804
        • St. John's Regional Health Center
      • Springfield, Missouri, Forenede Stater, 65807
        • Hulston Cancer Center at Cox Medical Center South
    • Nebraska
      • Lincoln, Nebraska, Forenede Stater, 68510
        • Cancer Resource Center - Lincoln
      • Omaha, Nebraska, Forenede Stater, 68106
        • CCOP - Missouri Valley Cancer Consortium
      • Omaha, Nebraska, Forenede Stater, 68114
        • Methodist Estabrook Cancer Center
    • New Jersey
      • Neptune, New Jersey, Forenede Stater, 07754-0397
        • Jersey Shore Cancer Center at Jersey Shore University Medical Center
      • Voorhees, New Jersey, Forenede Stater, 08043
        • Cancer Institute of New Jersey at Cooper - Voorhees
    • New York
      • Brooklyn, New York, Forenede Stater, 11203
        • SUNY downstate Medical Center
      • New York, New York, Forenede Stater, 10032
        • Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
      • Stony Brook, New York, Forenede Stater, 11794-9446
        • Stony Brook University Cancer Center
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27599-7295
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
      • Charlotte, North Carolina, Forenede Stater, 28232-2861
        • Blumenthal Cancer Center at Carolinas Medical Center
      • Winston-Salem, North Carolina, Forenede Stater, 27157-1096
        • Wake Forest University Comprehensive Cancer Center
    • Ohio
      • Akron, Ohio, Forenede Stater, 44307
        • McDowell Cancer Center at Akron General Medical Center
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Cleveland, Ohio, Forenede Stater, 44106-5065
        • Case Comprehensive Cancer Center
      • Cleveland, Ohio, Forenede Stater, 44111
        • Cleveland Clinic Cancer Center at Fairview Hospital
      • Columbus, Ohio, Forenede Stater, 43214-3998
        • Riverside Methodist Hospital Cancer Care
      • Columbus, Ohio, Forenede Stater, 43222
        • Mount Carmel Health - West Hospital
      • Mayfield Heights, Ohio, Forenede Stater, 44124
        • Hillcrest Cancer Center at Hillcrest Hospital
      • Mentor, Ohio, Forenede Stater, 44060
        • Lake/University Ireland Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • Oklahoma University Cancer Institute
      • Tulsa, Oklahoma, Forenede Stater, 74104
        • Cancer Care Associates - Midtown Tulsa
    • Pennsylvania
      • Abington, Pennsylvania, Forenede Stater, 19001
        • Rosenfeld Cancer Center at Abington Memorial Hospital
      • Bryn Mawr, Pennsylvania, Forenede Stater, 19010
        • Bryn Mawr Hospital
      • Hershey, Pennsylvania, Forenede Stater, 17033-0850
        • Penn State Cancer Institute at Milton S. Hershey Medical Center
      • Paoli, Pennsylvania, Forenede Stater, 19301-1792
        • Cancer Center of Paoli Memorial Hospital
      • Philadelphia, Pennsylvania, Forenede Stater, 19111-2497
        • Fox Chase Cancer Center - Philadelphia
      • Reading, Pennsylvania, Forenede Stater, 19612-6052
        • McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
      • Wynnewood, Pennsylvania, Forenede Stater, 19096
        • CCOP - MainLine Health
      • Wynnewood, Pennsylvania, Forenede Stater, 19096
        • Lankenau Cancer Center at Lankenau Hospital
    • South Dakota
      • Sioux Falls, South Dakota, Forenede Stater, 57105
        • Avera Cancer Institute
      • Sioux Falls, South Dakota, Forenede Stater, 57117-5039
        • Sanford Cancer Center at Sanford USD Medical Center
    • Texas
      • Amarillo, Texas, Forenede Stater, 79106
        • Harrington Cancer Center
    • Wisconsin
      • Marshfield, Wisconsin, Forenede Stater, 54449
        • Marshfield Clinic - Marshfield Center
      • Rice Lake, Wisconsin, Forenede Stater, 54868
        • Marshfield Clinic - Indianhead Center
      • Weston, Wisconsin, Forenede Stater, 54476
        • Marshfield Clinic - Weston 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 til 120 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

DISEASE CHARACTERISTICS:

  • Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cancer

    • Recurrent disease

  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan

    • At least 1 target lesion not in a previously irradiated field

  • Received 1, and only 1, prior platinum-based chemotherapy regimen for primary disease containing carboplatin, cisplatin, or other organoplatinum compound

    • Initial treatment may have included high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment
    • Patients who have not received prior paclitaxel may receive a second regimen that includes paclitaxel

  • Platinum-sensitive disease

    • Treatment-free interval* without clinical evidence of progressive disease for > 6 months after prior response to a platinum-based regimen NOTE: *Non-platinum maintenance or consolidation therapy is not included in calculation of the treatment-free interval
  • Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population)

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • GOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN

Renal

  • Creatinine ≤ 1.5 times ULN
  • Creatinine clearance > 40 mL/min

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No sensory or motor neuropathy > grade 1
  • No active infection requiring antibiotics
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 3 weeks since prior biologic or immunologic agents for the malignancy
  • No more than 1 prior non-cytotoxic (biologic or cytostatic) regimen (e.g., monoclonal antibodies, cytokines, or small molecule inhibitors of signal transduction) for recurrent disease
  • No concurrent cytokines during the first course of study treatment
  • No concurrent pegfilgrastim

Chemotherapy

  • See Disease Characteristics
  • See Biologic therapy
  • Recovered from prior chemotherapy
  • No other prior cytotoxic chemotherapy for recurrent disease, including retreatment with initial chemotherapy regimen
  • No prior topotecan

Endocrine therapy

  • At least 1 week since prior hormonal therapy for the malignancy
  • Concurrent hormone replacement therapy allowed

Radiotherapy

  • See Disease Characteristics
  • Recovered from prior radiotherapy
  • No prior radiotherapy to > 25% of marrow-bearing areas

Surgery

  • Recovered from prior surgery

Other

  • At least 3 weeks since other prior therapy for the malignancy
  • No prior anticancer therapy that would preclude study treatment

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
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Topotecan 1.25 mg/m2 IV days 1-5 of a 21 day cycle
Topotecan 1.25 mg/m2 IV days 1-5 of a 21 day cycle until disease progression or adverse effects prohibit further therapy
Medicin: topotecanhydrochlorid
Aktiv komparator: Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28 day cycle
Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28 day cycle until disease progression or adverse effects prohibit further therapy
Medicin: topotecanhydrochlorid

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective Tumor Response
Tidsramme: Every other cycle for the first 6 months, then every 3 months x2, then every 6 months until disease progression or study withdrawal

Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0):

Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart.

Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.

Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.

Stable Disease is any condition not meeting the above criteria.

Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease.
Every other cycle for the first 6 months, then every 3 months x2, then every 6 months until disease progression or study withdrawal
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Toxicity Criteria for Adverse Events Version 2.0
Tidsramme: Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up

Sekundære resultatmål

Resultatmål
Tidsramme
Reason Off Study Therapy
Tidsramme: study entry through end of study treatment, up to 5 years
study entry through end of study treatment, up to 5 years

Samarbejdspartnere og efterforskere

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

Sponsor

Gynecologic Oncology Group

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Studiestol: Thomas J. Herzog, MD, Herbert Irving Comprehensive Cancer Center

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. januar 2005

Primær færdiggørelse (Faktiske)

1. januar 2011

Datoer for studieregistrering

Først indsendt

13. juni 2005

Først indsendt, der opfyldte QC-kriterier

13. juni 2005

Først opslået (Skøn)

14. juni 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. juli 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. juni 2018

Sidst verificeret

1. maj 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GOG-0146Q
  • CDR0000434848

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 .

Kliniske forsøg med topotecanhydrochlorid

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Singapore

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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