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Combination Chemotherapy in Treating Patients With Recurrent or Refractory Small Cell Lung Cancer

12. juli 2016 oppdatert av: Alliance for Clinical Trials in Oncology

Phase II Trial of Gemcitabine/Irinotecan as Second Line Therapy for Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have recurrent or refractory small cell lung cancer.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

OBJECTIVES: I. Determine the overall, complete, and partial response rates of patients with recurrent or refractory small cell lung cancer when treated with gemcitabine plus irinotecan. II. Determine the overall and failure free survival of these patients when treated with this regimen. III. Determine the duration of response of these patients after this treatment. IV. Evaluate the toxicity associated with the administration of this treatment in this patient population.

OUTLINE: Patients are stratified according to prior response duration (progression 90 days or more after initial therapy vs progression less than 90 days after initial therapy or no response to initial therapy). Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year, then every 6 months for 2 years, and then annually for 3 years.

PROJECTED ACCRUAL: A total of 78 patients will be accrued for this study over 12-18 months.

Studietype

Intervensjonell

Registrering (Faktiske)

73

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
      • Birmingham, Alabama, Forente stater, 35233
        • Veterans Affairs Medical Center - Birmingham
    • California
      • La Jolla, California, Forente stater, 92093-0658
        • University of California San Diego Cancer Center
      • San Francisco, California, Forente stater, 94121
        • Veterans Affairs Medical Center - San Francisco
      • San Francisco, California, Forente stater, 94143-0128
        • UCSF Cancer Center and Cancer Research Institute
    • Delaware
      • Wilmington, Delaware, Forente stater, 19899
        • CCOP - Christiana Care Health Services
    • District of Columbia
      • Washington, District of Columbia, Forente stater, 20307-5000
        • Walter Reed Army Medical Center
      • Washington, District of Columbia, Forente stater, 20007
        • Lombardi Cancer Center
    • Florida
      • Miami Beach, Florida, Forente stater, 33140
        • CCOP - Mount Sinai Medical Center
    • Illinois
      • Chicago, Illinois, Forente stater, 60612
        • Veterans Affairs Medical Center - Chicago (Westside Hospital)
      • Chicago, Illinois, Forente stater, 60637-1470
        • University of Chicago Cancer Research Center
      • Chicago, Illinois, Forente stater, 60612
        • University of Illinois at Chicago Health Sciences Center
    • Iowa
      • Bettendorf, Iowa, Forente stater, 52722
        • Hematology Oncology Associates of the Quad Cities
      • Iowa City, Iowa, Forente stater, 52242-1009
        • Holden Comprehensive Cancer Center at the University of Iowa
    • Maine
      • Togus, Maine, Forente stater, 04330
        • Veterans Affairs Medical Center - Togus
    • Maryland
      • Baltimore, Maryland, Forente stater, 21201
        • Marlene & Stewart Greenebaum Cancer Center, University of Maryland
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02115
        • Dana-Farber Cancer Institute
      • Worcester, Massachusetts, Forente stater, 01655
        • University of Massachusetts Memorial Medical Center
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55417
        • Veterans Affairs Medical Center - Minneapolis
      • Minneapolis, Minnesota, Forente stater, 55455
        • University of Minnesota Cancer Center
    • Missouri
      • Columbia, Missouri, Forente stater, 65201
        • Veterans Affairs Medical Center - Columbia (Truman Memorial)
      • Columbia, Missouri, Forente stater, 65203
        • Ellis Fischel Cancer Center - Columbia
      • Saint Louis, Missouri, Forente stater, 63110
        • Barnes-Jewish Hospital
    • Nebraska
      • Omaha, Nebraska, Forente stater, 68198-3330
        • University of Nebraska Medical Center
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89106
        • CCOP - Southern Nevada Cancer Research Foundation
    • New Hampshire
      • Lebanon, New Hampshire, Forente stater, 03756-0002
        • Norris Cotton Cancer Center
    • New York
      • Buffalo, New York, Forente stater, 14263-0001
        • Roswell Park Cancer Institute
      • Buffalo, New York, Forente stater, 14215
        • Veterans Affairs Medical Center - Buffalo
      • Manhasset, New York, Forente stater, 11030
        • CCOP - North Shore University Hospital
      • Manhasset, New York, Forente stater, 11030
        • North Shore University Hospital
      • New York, New York, Forente stater, 10021
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, Forente stater, 10021
        • New York Presbyterian Hospital - Cornell Campus
      • New York, New York, Forente stater, 10029
        • Mount Sinai Medical Center, NY
      • Syracuse, New York, Forente stater, 13210
        • State University of New York - Upstate Medical University
      • Syracuse, New York, Forente stater, 13210
        • Veterans Affairs Medical Center - Syracuse
      • Syracuse, New York, Forente stater, 13217
        • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
    • North Carolina
      • Chapel Hill, North Carolina, Forente stater, 27599-7295
        • Lineberger Comprehensive Cancer Center, UNC
      • Durham, North Carolina, Forente stater, 27705
        • Veterans Affairs Medical Center - Durham
      • Durham, North Carolina, Forente stater, 27710
        • Duke Comprehensive Cancer Center
      • Winston-Salem, North Carolina, Forente stater, 27104-4241
        • CCOP - Southeast Cancer Control Consortium
      • Winston-Salem, North Carolina, Forente stater, 27157-1082
        • Comprehensive Cancer Center at Wake Forest University
    • Ohio
      • Columbus, Ohio, Forente stater, 43210-1240
        • Arthur G. James Cancer Hospital - Ohio State University
    • Rhode Island
      • Providence, Rhode Island, Forente stater, 02903
        • Rhode Island Hospital
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29425-0721
        • Medical University of South Carolina
    • Tennessee
      • Memphis, Tennessee, Forente stater, 38103
        • University of Tennessee, Memphis Cancer Center
      • Memphis, Tennessee, Forente stater, 38104
        • Veterans Affairs Medical Center - Memphis
    • Vermont
      • Bennington, Vermont, Forente stater, 05201
        • CCOP - Southwestern Vermont Regional Cancer Center
      • Burlington, Vermont, Forente stater, 05401-3498
        • Vermont Cancer Center
      • White River Junction, Vermont, Forente stater, 05009
        • Veterans Affairs Medical Center - White River Junction
    • Virginia
      • Richmond, Virginia, Forente stater, 23298-0037
        • MBCCOP - Massey Cancer Center
      • Richmond, Virginia, Forente stater, 23249
        • Veterans Affairs Medical Center - Richmond

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 recurrent or refractory small cell lung cancer Measurable disease At least 20 mm with conventional techniques OR At least 10 mm with spiral CT scan The following are not considered measurable: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Abdominal masses not confirmed and followed by imaging techniques Cystic lesions Tumor lesions situated in a previously irradiated area Known CNS metastases allowed

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: CTC 0-2 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception No prior or concurrent malignancy in past 5 years except curatively treated carcinoma in situ of the cervix, breast, or basal cell or squamous cell carcinoma of the skin

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than 1 prior chemotherapy or chemoradiotherapy regimen No prior gemcitabine or irinotecan Endocrine therapy: Not specified Radiotherapy: No more than 1 prior chemoradiotherapy regimen At least 2 weeks since prior cranial radiotherapy for CNS metastases No concurrent cranial radiotherapy Surgery: Not specified

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: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: gemcitabine + irinotecan
Patients are stratified according to prior response duration (progression 90 days or more after initial therapy vs progression less than 90 days after initial therapy or no response to initial therapy). Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year, then every 6 months for 2 years, and then annually for 3 years.
Legemiddel: irinotekanhydroklorid
Legemiddel: gemcitabinhydroklorid

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
overall response rate
Tidsramme: Up to 18 weeks
Up to 18 weeks

Sekundære resultatmål

Resultatmål
Tidsramme
overall survival
Tidsramme: Up to 18 weeks
Up to 18 weeks
failure-free survival
Tidsramme: Up to 18 weeks
Up to 18 weeks

Samarbeidspartnere og etterforskere

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

Sponsor

Alliance for Clinical Trials in Oncology

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

  • Studiestol: Caio Max Rocha Lima, MD, Medical University of South Carolina

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. mai 2000

Primær fullføring (Faktiske)

1. oktober 2006

Studiet fullført (Faktiske)

1. februar 2008

Datoer for studieregistrering

Først innsendt

5. juli 2000

Først innsendt som oppfylte QC-kriteriene

23. mars 2004

Først lagt ut (Anslag)

24. mars 2004

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

14. juli 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. juli 2016

Sist bekreftet

1. juli 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CALGB-39902
  • U10CA031946 (U.S. NIH-stipend/kontrakt)
  • CDR0000067959 (Registeridentifikator: NCI Physician Data Query)

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. .

Kliniske studier på Lungekreft

Kliniske studier på irinotekanhydroklorid

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