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Topotecan in Treating Patients With Relapsed Small Cell Lung Cancer

8. januar 2014 opdateret af: Case Comprehensive Cancer Center

An Open Label, Multicenter, Randomized, Phase III Comparator Study of Oral Topotecan Versus Intravenous Topotecan for Second Line Therapy in Patients With Small Cell Lung Cancer Who Have Relapsed Greater Than or Equal to 90 Days After Completion of First Line Therapy

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if topotecan is more effective given by infusion or by mouth.

PURPOSE: Randomized phase III trial to compare the effectiveness of topotecan given by infusion with that of topotecan given by mouth in treating patients who have small cell lung cancer that has relapsed following previous therapy.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES: I. Compare the response rate, response duration, time to response, time to progression, and survival of patients with relapsed limited or extensive stage small cell lung cancer treated with oral vs intravenous topotecan. II. Compare the qualitative and quantitative toxicities of these treatment regimens in this patient population. III. Compare the quality of life in these patients.

OUTLINE: This is randomized, multicenter study. Patients are stratified according to gender, liver metastases (yes vs no), and duration of response to prior chemotherapy (6 months or less vs greater than 6 months). Patients are randomized to one of two treatment arms. Arm I: Patients receive topotecan IV over 30 minutes on days 1-5. Arm II: Patients receive topotecan orally on days 1-5. Treatment repeats every 3 weeks in the absence of unacceptable toxicity. Patients experiencing complete or partial response continue until progression or for at least 2 courses past maximal response. Patients with stable disease should receive at least 4 courses. Quality of life is assessed Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

4

Fase

  • Fase 3

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 Comprehensive Cancer Center
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85012
        • Veterans Affairs Medical Center - Phoenix (Hayden)
    • California
      • Bakersfield, California, Forenede Stater, 93309
        • Comprehensive Blood and Cancer Center
      • Fountain Valley, California, Forenede Stater, 92708
        • Pacific Coast Hematology/Oncology Medical Group
      • La Jolla, California, Forenede Stater, 92037
        • Scripps Clinic
      • Los Angeles, California, Forenede Stater, 90073
        • Veterans Affairs Medical Center - West Los Angeles
      • Poway, California, Forenede Stater, 92064
        • Southwest Cancer Care
      • Sacramento, California, Forenede Stater, 95817
        • University of California Davis Cancer Center
      • San Diego, California, Forenede Stater, 92120
        • Kaiser Permanente-Southern California Permanente Medical Group
      • San Diego, California, Forenede Stater, 92121
        • Sidney Kimmel Cancer Center
    • Colorado
      • Colorado Springs, Colorado, Forenede Stater, 80909
        • Oncology Clinic, P.C.
    • Florida
      • Gainesville, Florida, Forenede Stater, 32610
        • Shands Cancer Center
      • Jacksonville, Florida, Forenede Stater, 32207
        • Baptist Regional Cancer Institute - Jacksonville
      • Miami, Florida, Forenede Stater, 33176
        • Oncology-Hematology Group of South Florida
      • Pensacola, Florida, Forenede Stater, 32522
        • Baptist Hospital- Pensacola
      • Tampa, Florida, Forenede Stater, 33612
        • H. Lee Moffitt Cancer Center and Research Institute
    • Georgia
      • Augusta, Georgia, Forenede Stater, 30912-3620
        • Medical College of Georgia Hospital and Clinics
    • Illinois
      • Evanston, Illinois, Forenede Stater, 60201
        • Evanston Northwestern Health Care
      • Hines, Illinois, Forenede Stater, 60141
        • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46219
        • Oncology and Hematology Associates, Inc.
    • Louisiana
      • Lafayette, Louisiana, Forenede Stater, 70506
        • Louisiana Oncology Associates
      • New Orleans, Louisiana, Forenede Stater, 70121
        • Alton Ochsner Medical Foundation Hospital
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48202
        • Henry Ford Hospital
      • Pontiac, Michigan, Forenede Stater, 48341-2985
        • St. Joseph Mercy Hospital
    • Minnesota
      • Saint Louis Park, Minnesota, Forenede Stater, 55416
        • CCOP - Metro-Minnesota
    • Missouri
      • Saint Louis, Missouri, Forenede Stater, 63141
        • St. John's Mercy Medical Center
    • New Jersey
      • Camden, New Jersey, Forenede Stater, 08103
        • Cooper Cancer Institute
      • Livingston, New Jersey, Forenede Stater, 07039
        • St. Barnabas Medical Center
      • Voorhees, New Jersey, Forenede Stater, 08043
        • Cooper Hospital/University Medical Center
    • New Mexico
      • Santa Fe, New Mexico, Forenede Stater, 87505
        • Santa Fe Hematology/Oncology
    • New York
      • Rochester, New York, Forenede Stater, 14621
        • Rochester General Hospital
      • Syracuse, New York, Forenede Stater, 13210
        • State University of New York - Upstate Medical University
    • North Carolina
      • Winston-Salem, North Carolina, Forenede Stater, 27157-1082
        • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • Salem Research
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44106-5065
        • Ireland Cancer Center
    • Pennsylvania
      • Hershey, Pennsylvania, Forenede Stater, 17033
        • Penn State Geisinger Cancer Center
      • Lemoyne, Pennsylvania, Forenede Stater, 17043-1440
        • Central Pennsylvania Hematology & Medical Oncology Associates, PC
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • University of Pittsburgh Cancer Institute
      • Reading, Pennsylvania, Forenede Stater, 19612-6052
        • Reading Hospital and Medical Center
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02912
        • Brown University Oncology Group
    • South Carolina
      • Greenville, South Carolina, Forenede Stater, 29605
        • Cancer Centers of the Carolinas
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • Spartanburg Regional Healthcare System
    • Tennessee
      • Knoxville, Tennessee, Forenede Stater, 37901
        • Baptist Regional Cancer Center - Knoxville
      • Nashville, Tennessee, Forenede Stater, 37203
        • Sarah Cannon-Minnie Pearl Cancer Center
    • Texas
      • Fort Worth, Texas, Forenede Stater, 76104
        • Texas Cancer Care
      • Galveston, Texas, Forenede Stater, 77555-0209
        • University of Texas Medical Branch
      • Houston, Texas, Forenede Stater, 77030-4009
        • University of Texas - MD Anderson Cancer Center
      • Lubbock, Texas, Forenede Stater, 79410
        • Joe Arrington Cancer Center
      • Temple, Texas, Forenede Stater, 76508
        • Scott and White Memorial Hospital
    • Virginia
      • Norfolk, Virginia, Forenede Stater, 23502
        • Office of Michael E. Lee
      • Richmond, Virginia, Forenede Stater, 23226
        • Hematology & Oncology Associates of Virginia
      • Roanoke, Virginia, Forenede Stater, 24014
        • Oncology and Hematology Associates of Southwest Virginia, Inc.
    • Wisconsin
      • Waukesha, Wisconsin, Forenede Stater, 53188
        • Waukesha Memorial 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

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed limited or extensive stage small cell lung cancer (SCLC) Disease recurring at least 90 days following completion of first line chemotherapy Partial or complete response to first line therapy Must have at least one bidimensionally measurable non CNS lesion May be within a prior radiation port if at least 6 weeks since prior radiotherapy and progressing Brain and/or leptomeningeal metastases allowed if asymptomatic and not requiring corticosteroids

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 2 months Hematopoietic: WBC at least 3,500/mm3 Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL (after transfusion, if needed) Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT and SGPT no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present) Alkaline phosphatase no greater than 2 times ULN (no greater than 5 times ULN if liver metastases present) Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Other: No active uncontrolled infection No other malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I low grade prostate cancer No other severe medical conditions that would preclude study or cause exposure to extreme risk or decreased life expectancy No uncontrolled emesis No active peptic ulcer, diabetes mellitus, chronic gastritis, significant ascites, or other gastrointestinal (GI) conditions (e.g., removal of a portion of the stomach or recent GI obstruction) that would alter absorption or GI motility No history of allergic reactions to compounds chemically related to topotecan Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception for 3 months prior to, during, and at least 4 weeks after the study

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 months since prior immunotherapy No concurrent immunotherapy for SCLC Chemotherapy: See Disease Characteristics No prior topotecan Only one prior chemotherapy regimen allowed No other concurrent chemotherapy for SCLC Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics At least 24 hours since prior radiotherapy No concurrent radiotherapy for SCLC Surgery: At least 4 weeks since prior surgery Other: At least 30 days or five half lives since other prior investigational drugs No prior drugs (e.g., cisapride) that would alter absorption or GI motility No other concurrent investigational therapy for SCLC

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: Enkelt gruppeopgave

Samarbejdspartnere og efterforskere

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

Sponsor

Case Comprehensive Cancer Center

Samarbejdspartnere

Smith Kline Beecham

Efterforskere

  • Studiestol: Nathan Levitan, MD, Case 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. marts 1999

Primær færdiggørelse (Faktiske)

1. november 2001

Studieafslutning (Faktiske)

1. november 2001

Datoer for studieregistrering

Først indsendt

1. november 1999

Først indsendt, der opfyldte QC-kriterier

13. april 2004

Først opslået (Skøn)

14. april 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

9. januar 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. januar 2014

Sidst verificeret

1. januar 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SKF1598
  • CWRU-SKF-1598
  • SB-104864-A/396
  • NCI-G99-1524

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 Lungekræft

Kliniske forsøg med topotecanhydrochlorid

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in France

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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