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Carboplatin, Gemcitabine, and Thalidomide in Patients Undergoing Surgery for Stage II or III Non-Small Cell Lung Cancer

3. december 2017 opdateret af: Masonic Cancer Center, University of Minnesota

Phase II Trial of Neoadjuvant Therapy With Carboplatin and Gemcitabine With Thalidomide in Patients With Stage II and IIIA Non-Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy, such as carboplatin and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of tumor cells by blocking blood flow to the tumor. Giving carboplatin and gemcitabine together with thalidomide before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well giving carboplatin and gemcitabine together with thalidomide works in treating patients who are undergoing surgery for stage II or stage III non-small cell lung cancer.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

Primary

  • Determine the complete and partial response rates in patients with stage II or IIIA non-small cell lung cancer treated with neoadjuvant carboplatin, gemcitabine hydrochloride, and thalidomide.

Secondary

  • Determine, preliminarily, the mechanism of action and activity of thalidomide against lung cancer.
  • Determine the 1-year and 2-year survival of patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.
  • Determine the operative mortality of patients treated with this regimen.

OUTLINE: This is a pilot study.

Patients receive carboplatin intravenously (IV) over 30 minutes on day 1, gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and oral thalidomide once daily on days 1-21. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Within 2-6 weeks after the completion of chemotherapy, patients with resectable tumors undergo surgical resection.

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

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

22

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
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55455
        • University of Minnesota Cancer Center
      • Robbinsdale, Minnesota, Forenede Stater, 55422-2900
        • Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
    • New Hampshire
      • Lebanon, New Hampshire, Forenede Stater, 03756-0002
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical 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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), including any of the following histologic subtypes:

    • Squamous cell carcinoma
    • Adenocarcinoma
    • Large cell undifferentiated carcinoma
  • Stage II or IIIA disease
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral Computerized Axial Tomography (CT) scan
  • No tumor involving the superior sulcus (e.g., Pancoast tumor)
  • Karnofsky performance status 70-100%
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Creatinine ≤ 2 mg/dL
  • Bilirubin < 2 mg/dL
  • Aspartate aminotransferase (AST) < 3 times upper limit of normal

Exclusion Criteria:

  • Pregnant or nursing

    • No nursing during and for ≥ 4 weeks after completion of study treatment
  • Positive pregnancy test
  • Fertile female patients must use 2 effective methods of contraception 4 weeks before, during, and for 4 weeks after completion of study treatment
  • Fertile male patients must use effective barrier contraception during and for 4 weeks after completion of study treatment
  • Blood, sperm, or ova donation during study treatment
  • Post obstructive pneumonia
  • Other serious infection or medical illness that would preclude study participation
  • Other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other malignancy that is unlikely to affect survival for the next 3 years
  • Less than 5 years since prior resection of lung disease
  • Prior systemic chemotherapy or radiotherapy for non-small cell lung cancer (NSCLC)
  • Other concurrent chemotherapy or radiotherapy
  • Concurrent hormonal therapy or immunotherapy
  • Other concurrent anticancer therapy
  • Other concurrent investigational agents
  • Concurrent participation in another clinical study

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: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Treatment Arm
Chemotherapy treatment (carboplatin, gemcitabine and thalidomide) every 21 days for 3 courses.
Medicin: carboplatin
Day 1 of Cycles 1, 2 and 3 - intravenously (IV) 30 minutes (Area Under the Curve = 5.5)
Andre navne:
  • PARAPLATIN
Medicin: gemcitabine hydrochloride
Days 1 and 8 of Cycles 1, 2 and 3 - 30 minute IV, 1000 mg/m2.
Andre navne:
  • Gemzar
Medicin: thalidomide
Oral administration: Cycle 1 - Day 1 50 mg, Day 2 100 mg, Day 3 150 mg, Day 4 and continuing until end of study treatment 200 mg.
Andre navne:
  • Thalidomid
Procedure: conventional surgery
Resection - between 2 and 6 weeks following last dose of chemotherapy.
Andre navne:
  • Kirurgi
  • Resektion

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Patients Reporting Clinical Response
Tidsramme: At end of 3 -21 day cycles of treatment
Objective clinical response measuring using tumor assessments: Complete Response (CR) = disappearance of all target and non-target lesions and normalization of tumor marker level, if applicable. Pathological Complete Response (PCR) = No viable tumor cells in specimen determined by light microscopy. Partial Response (PR) = at least 30% decrease in the sum of longest diameter of target lesions from baseline. Progressive Disease (PD) = at least 20% increase in the sum of longest diameters of target lesions from baseline or new lesions. Stable Disease (SD) = Neither PR or PD.
At end of 3 -21 day cycles of treatment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Patients Disease-free at 1 Year
Tidsramme: 1 year
Calculated from date of enrollment to date of recurrence or death, whichever came first
1 year
Number of Patients Disease-free at 2 Years
Tidsramme: 2 Years
Calculated from date of enrollment to date of recurrence or death, whichever came first
2 Years
Number of Patients Alive at 1 Year (Survival)
Tidsramme: 12 Months
Participants who were alive at one year from date of enrollment .
12 Months
Number of Patients Alive at 2 Years (Survival)
Tidsramme: 24 Months
Participants who were alive at 2 years from date of enrollment.
24 Months
Number of Patients Alive at 56 Months (End of Study)
Tidsramme: Up to 56 months
Patients alive from date of enrollment to date of death or censored at date of last contact (Overall Survival).
Up to 56 months

Samarbejdspartnere og efterforskere

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

Sponsor

Masonic Cancer Center, University of Minnesota

Efterforskere

  • Studiestol: Arkadiusz Dudek, MD, Masonic Cancer Center, University of Minnesota

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. maj 2002

Primær færdiggørelse (Faktiske)

1. marts 2008

Studieafslutning (Faktiske)

1. juli 2008

Datoer for studieregistrering

Først indsendt

24. januar 2006

Først indsendt, der opfyldte QC-kriterier

24. januar 2006

Først opslået (Skøn)

25. januar 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. december 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. december 2017

Sidst verificeret

1. december 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2002LS013
  • LILLY-X-382 (Anden identifikator: Eli Lilly)
  • 0202M17981 (Anden identifikator: IRB, University of Minnesota)

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 .

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