Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

FDG-Labeled PET Scan in Planning Chemotherapy in Treating Patients With Stage IIIB or IV Non-Small Cell Lung Cancer

16. desember 2016 oppdatert av: Keith D Eaton, University of Washington

FDG-PET Based Chemotherapy Selection for Metastatic Non-Small Cell Lung Cancer

This phase II trial studies how well fludeoxyglucose F 18 (FDG)-labeled positron emission tomography (PET) scan works in planning chemotherapy in treating patients with stage IIIB or IV non-small cell lung cancer (NSCLC). Drugs used in chemotherapy, such as paclitaxel, carboplatin, gemcitabine hydrochloride, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Diagnostic imaging procedures, such as FDG-labeled PET scan, may help in guiding chemotherapy and allow doctors to plan better treatment

Studieoversikt

Detaljert beskrivelse

PRIMARY OBJECTIVES:

I. Assess the response rate in patients who do not demonstrate an early response to carboplatin/paclitaxel as determined by FDG-PET ("initial non-responders") who are subsequently treated with three additional courses of docetaxel/gemcitabine.

SECONDARY OBJECTIVES:

I. Evaluate the ability of FDG-PET to predict response to therapy as measured by computed tomography (CT).

II. Evaluate the early and late changes in tumor FDG uptake (change in standardized uptake value [SUV]) in all patients and correlate with overall survival (OS).

OUTLINE: All patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Patients undergo FDG-PET/CT scan between days 18-21.

Patients are then assigned to 1 of 2 treatment groups.

GROUP I (Responders): Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 3 additional courses in the absence of disease progression or unacceptable toxicity.

GROUP II (Initial non-responders): Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG-PET/CT scan between days 18-21 of course 2.

After completion of study treatment, patients are followed up at days 81-84 and then periodically thereafter.

Studietype

Intervensjonell

Registrering (Faktiske)

55

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiesteder

    • Washington
      • Seattle, Washington, Forente stater, 98109
        • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
      • Seattle, Washington, Forente stater, 98104
        • Harborview Medical Center

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

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed NSCLC; patients must have stage IIIB with malignant pleural effusion or with nodal disease so extensive that it is not amenable to radiotherapy with curative intent, or stage IV disease, as defined by the American Joint Committee on Cancer (AJCC) cancer staging handbook, 6th Edition (2002)
  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (>= 10 mm with spiral CT scan); patients' baseline FDG-PET scan must demonstrate a target lesion with SUV >= 2 x background and SUV > 3
  • All patients must not have received treatment with conventional cytotoxic chemotherapy for NSCLC; patients may have had prior radiotherapy or may have been treated with the epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI) (i.e. erlotinib or gefitinib); one week must have elapsed after discontinuation, prior to the initial PET scan for patients previously treated with a TKI; patients who receive radiotherapy must have recovered from the side effects of therapy (except alopecia) and have measurable disease (target lesion) outside of the radiation field
  • Life expectancy >= 3 months
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • Absolute neutrophil count >= 1,500/mcL
  • Platelets >= 100,000/mcL
  • Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
  • Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase [SGPT]) =< 2 x institutional ULN (< 5 x ULN for patients with liver metastases)
  • Creatinine =< 1.5 x ULN OR creatinine clearance >= 40 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
  • Patients must have baseline FDG-PET and CT scans performed at the University of Washington (UW)/Seattle Cancer Care Alliance (SCCA) within two weeks from the start of chemotherapy
  • Asymptomatic patients with clinically stable brain metastases (treated or untreated) are allowed
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) throughout treatment and for 30 days following the last dose of chemotherapy
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Patients who have received EGFR TKI (i.e. erlotinib or gefitinib) within one week prior to entering the study
  • Patients may not be receiving any other investigational agents
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition agents used in the study
  • Inability or unwillingness to take corticosteroids, which are required pre-medications for the chemotherapies in this trial
  • Diabetes requiring insulin for management
  • Patients must weigh less than 400 lbs
  • Patients with post-obstructive pneumonia or lobar collapse
  • Significant neuropathy (common toxicity criteria [CTC] grade > 2), as both the paclitaxel and docetaxel have potential for neurotoxicity
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant or breastfeeding women
  • Patients with a detectable second malignancy are excluded, as this could confound tumor evaluation and affect patient survival
  • Patients who are likely to need palliative radiation therapy for painful bony metastases, impending fractures, or hemoptysis

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: Chemotherapy
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients undergo FDG PET/CT (fludeoxyglucose F 18 positron emission tomography/computed tomography) scan between days 18-21. The FDG PET/CT is an imaging biomarker analysis. Patients that are responding to treatment receive paclitaxel IV and carboplatin IV on day 1. Treatment repeats every 3 weeks for up to 3 additional courses in the absence of disease progression or unacceptable toxicity.Patients that are not responding to chemotherapy per FDG PET then receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Non-responding patients undergo an additional FDG PET/CT scan between days 18-21 of course 2.
Gitt IV
Andre navn:
  • Gemzar
  • gemcitabin
  • dFdC
  • difluordeoksycytidinhydroklorid
Gitt IV
Andre navn:
  • Taxol
  • Anzatax
  • Asotax
  • AVGIFT
Gitt IV
Andre navn:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplatin
  • Paraplat
Gitt IV
Andre navn:
  • Taxotere
  • RP 56976
  • Tekst
Gitt IV
Andre navn:
  • 18FDG
  • FDG
Gjennomgå FDG PET/CT
Andre navn:
  • tomografi, beregnet
Gjennomgå FDG PET/CT
Andre navn:
  • KJÆLEDYR
  • FDG-PET
  • PET-skanning
  • tomografi, utslipp beregnet
Correlative studies

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall Response Rate (Patients That Achieve a CR or PR)
Tidsramme: At the end of 4 cycles of treatment, up to 24 weeks.
Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
At the end of 4 cycles of treatment, up to 24 weeks.

Samarbeidspartnere og etterforskere

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

Samarbeidspartnere

Etterforskere

  • Hovedetterforsker: Keith Eaton, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

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. oktober 2007

Primær fullføring (Faktiske)

1. september 2011

Studiet fullført (Faktiske)

1. mars 2012

Datoer for studieregistrering

Først innsendt

27. november 2007

Først innsendt som oppfylte QC-kriteriene

27. november 2007

Først lagt ut (Anslag)

28. november 2007

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. februar 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. desember 2016

Sist bekreftet

1. desember 2016

Mer informasjon

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. .

Abonnere