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Topotecan in Treating Patients With Relapsed Small Cell Lung Cancer

8. januar 2014 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

4

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35294
        • University of Alabama Comprehensive Cancer Center
    • Arizona
      • Phoenix, Arizona, Forente stater, 85012
        • Veterans Affairs Medical Center - Phoenix (Hayden)
    • California
      • Bakersfield, California, Forente stater, 93309
        • Comprehensive Blood and Cancer Center
      • Fountain Valley, California, Forente stater, 92708
        • Pacific Coast Hematology/Oncology Medical Group
      • La Jolla, California, Forente stater, 92037
        • Scripps Clinic
      • Los Angeles, California, Forente stater, 90073
        • Veterans Affairs Medical Center - West Los Angeles
      • Poway, California, Forente stater, 92064
        • Southwest Cancer Care
      • Sacramento, California, Forente stater, 95817
        • University of California Davis Cancer Center
      • San Diego, California, Forente stater, 92120
        • Kaiser Permanente-Southern California Permanente Medical Group
      • San Diego, California, Forente stater, 92121
        • Sidney Kimmel Cancer Center
    • Colorado
      • Colorado Springs, Colorado, Forente stater, 80909
        • Oncology Clinic, P.C.
    • Florida
      • Gainesville, Florida, Forente stater, 32610
        • Shands Cancer Center
      • Jacksonville, Florida, Forente stater, 32207
        • Baptist Regional Cancer Institute - Jacksonville
      • Miami, Florida, Forente stater, 33176
        • Oncology-Hematology Group of South Florida
      • Pensacola, Florida, Forente stater, 32522
        • Baptist Hospital- Pensacola
      • Tampa, Florida, Forente stater, 33612
        • H. Lee Moffitt Cancer Center and Research Institute
    • Georgia
      • Augusta, Georgia, Forente stater, 30912-3620
        • Medical College of Georgia Hospital and Clinics
    • Illinois
      • Evanston, Illinois, Forente stater, 60201
        • Evanston Northwestern Health Care
      • Hines, Illinois, Forente stater, 60141
        • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46219
        • Oncology and Hematology Associates, Inc.
    • Louisiana
      • Lafayette, Louisiana, Forente stater, 70506
        • Louisiana Oncology Associates
      • New Orleans, Louisiana, Forente stater, 70121
        • Alton Ochsner Medical Foundation Hospital
    • Michigan
      • Detroit, Michigan, Forente stater, 48202
        • Henry Ford Hospital
      • Pontiac, Michigan, Forente stater, 48341-2985
        • St. Joseph Mercy Hospital
    • Minnesota
      • Saint Louis Park, Minnesota, Forente stater, 55416
        • CCOP - Metro-Minnesota
    • Missouri
      • Saint Louis, Missouri, Forente stater, 63141
        • St. John's Mercy Medical Center
    • New Jersey
      • Camden, New Jersey, Forente stater, 08103
        • Cooper Cancer Institute
      • Livingston, New Jersey, Forente stater, 07039
        • St. Barnabas Medical Center
      • Voorhees, New Jersey, Forente stater, 08043
        • Cooper Hospital/University Medical Center
    • New Mexico
      • Santa Fe, New Mexico, Forente stater, 87505
        • Santa Fe Hematology/Oncology
    • New York
      • Rochester, New York, Forente stater, 14621
        • Rochester General Hospital
      • Syracuse, New York, Forente stater, 13210
        • State University of New York - Upstate Medical University
    • North Carolina
      • Winston-Salem, North Carolina, Forente stater, 27157-1082
        • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
      • Winston-Salem, North Carolina, Forente stater, 27103
        • Salem Research
    • Ohio
      • Cleveland, Ohio, Forente stater, 44106-5065
        • Ireland Cancer Center
    • Pennsylvania
      • Hershey, Pennsylvania, Forente stater, 17033
        • Penn State Geisinger Cancer Center
      • Lemoyne, Pennsylvania, Forente stater, 17043-1440
        • Central Pennsylvania Hematology & Medical Oncology Associates, PC
      • Pittsburgh, Pennsylvania, Forente stater, 15213
        • University of Pittsburgh Cancer Institute
      • Reading, Pennsylvania, Forente stater, 19612-6052
        • Reading Hospital and Medical Center
    • Rhode Island
      • Providence, Rhode Island, Forente stater, 02912
        • Brown University Oncology Group
    • South Carolina
      • Greenville, South Carolina, Forente stater, 29605
        • Cancer Centers of the Carolinas
      • Spartanburg, South Carolina, Forente stater, 29303
        • Spartanburg Regional Healthcare System
    • Tennessee
      • Knoxville, Tennessee, Forente stater, 37901
        • Baptist Regional Cancer Center - Knoxville
      • Nashville, Tennessee, Forente stater, 37203
        • Sarah Cannon-Minnie Pearl Cancer Center
    • Texas
      • Fort Worth, Texas, Forente stater, 76104
        • Texas Cancer Care
      • Galveston, Texas, Forente stater, 77555-0209
        • University of Texas Medical Branch
      • Houston, Texas, Forente stater, 77030-4009
        • University of Texas - MD Anderson Cancer Center
      • Lubbock, Texas, Forente stater, 79410
        • Joe Arrington Cancer Center
      • Temple, Texas, Forente stater, 76508
        • Scott and White Memorial Hospital
    • Virginia
      • Norfolk, Virginia, Forente stater, 23502
        • Office of Michael E. Lee
      • Richmond, Virginia, Forente stater, 23226
        • Hematology & Oncology Associates of Virginia
      • Roanoke, Virginia, Forente stater, 24014
        • Oncology and Hematology Associates of Southwest Virginia, Inc.
    • Wisconsin
      • Waukesha, Wisconsin, Forente stater, 53188
        • Waukesha Memorial 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

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

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag

Samarbeidspartnere og etterforskere

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

Sponsor

Case Comprehensive Cancer Center

Samarbeidspartnere

Smith Kline Beecham

Etterforskere

  • Studiestol: Nathan Levitan, MD, Case Comprehensive Cancer Center

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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. mars 1999

Primær fullføring (Faktiske)

1. november 2001

Studiet fullført (Faktiske)

1. november 2001

Datoer for studieregistrering

Først innsendt

1. november 1999

Først innsendt som oppfylte QC-kriteriene

13. april 2004

Først lagt ut (Anslag)

14. april 2004

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

9. januar 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. januar 2014

Sist bekreftet

1. januar 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

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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