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Customizing First Line Chemotherapy in Advanced Non-Small Cell Lung Cancer (Customizing)

19. januar 2014 oppdatert av: National Guard Health Affairs

A Pilot Study of Customizing First Line Chemotherapy in Advanced Non-Small Cell Lung Cancer Based on Molecular Markers

The study aims at piloting the concept of customization of chemotherapy based on molecular markers in patients with stage IIIB (with pleural effusion) and IV with performance status ≤ 2 with pathologically proven non-small cell lung cancer (NSCLC). The study will not test or compare individual regimen but rather it will test the approach of customization concept as a whole.

The results of this pilot study will help in designing more definitive trials in our patient population.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The treatment of advanced NSCLC cancer includes various chemotherapies with equivalent regimens that have reached a therapeutic plateau. The selection of these regimens is completely empirical and physician dependent. Potential predictors of specific agent efficacy exist in the form of tumor molecular markers that are a reflection of the individual's genetic make up. Thus our study aims at utilizing these markers to more efficiently select the regimen in order to maximize the benefit to the patients rather than using empiric approaches. Fortunately, each of our selected regimens contains active and well-studied agents in the treatment of lung cancer (Table 1). This pilot study will help us determine the benefit, and safety of this approach (not individual regimen). The study is not to compare individual regimens but it aims at testing the whole concept of customization of chemotherapy based on molecular markers to help us in the future at selecting regimens based on these markers and not empirically. The results then will be used to determine more definitive future studies.

Furthermore, circulating tumor cells in the blood represent the future distant metastases that result in disease progression to incurable stages. The circulating tumor cells have the ability to cross into vessels, travel in circulation, and exit the vessels into tissues where they have the capability to grow. Therefore, these cells may express different biological and molecular features from the stationary cells in the primary tumors. Therefore, exploiting these circulating tumor cells for augmenting treatment approaches is of vital importance and utility.

Studietype

Intervensjonell

Registrering (Faktiske)

3

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiesteder

  • Saudi-Arabia
      • Riyadh, Saudi-Arabia
        • King Abdul Aziz Medical City for National Guard Health Affairs

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:

  1. Microscopic diagnosis of NSCLC stages IIIB (with malignant pleural effusion) and IV
  2. Having adequate tissue sample to perform the markers testing
  3. Age ≥ 18 years
  4. No prior chemotherapy treatment for lung cancer (Surgery and radiotherapy are acceptable)
  5. No other concurrent cancer treatment
  6. Performance status of 0- 2 per ECOG scale (Appendix II)

  7. Adequate laboratory values as follows as follows:

    Absolute neutrophil count ≥ 1500/mm3 Platelet count ≥100, 000/ mm3 Total bilirubin ≤ 1.25X institutional upper normal level AST and ALT ≤ 3 X institutional upper normal level Serum creatinine ≤ 1.5 X institutional upper normal level

  8. Presence of measurable disease

Exclusion Criteria:

  1. Prior systemic treatment for lung cancer
  2. History of hypersensitivity to drugs used
  3. Diagnosis of other malignancy in the last 5 years excluding curatively treated non-melanoma skin cancer and in-situ cervical cancer
  4. Medical illness that puts the patient at significant risk per investigator's discretion
  5. Uncontrolled CNS disease. Patients with CNS metastatic disease treated with radiotherapy or surgery will be eligible if the CNS disease is stable 4 weeks after the treatment initiation without increase dose of steroids
  6. Positive pregnancy test or refusal to use contraception during treatment. (Gynecology consultant for contraception)

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: Cisplatin,Docetaxel,Gemzar, Premetrexed
Patients will receive treatment for up to six cycles of the assigned regimen unless there is disease progression or unacceptable toxicities. After treatment, the patients will be seen every 2 months for the first year, then every 3 months for the second year and every 6 months afterwards.
Legemiddel: Cisplatin, Gemzar, Docetaxel, Alimta
Patients will be assigned to treatment according to the molecular biological results which will analyze excision repair cross-complementing (ERCC1), ribonucleotide reductase subunit M1 (RRM1) and beta-tubulin genes in primary tumor cells which are present in tissues and peripheral blood.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Efficacy and Safety
Tidsramme: 3 years

  1. Efficacy is measured by:

    • overall response rate (partial response and complete response) using RECIST Criteria
    • time to disease progression (TTP)
    • progression free survival (PFS)
    • overall survival (OS)

  2. To evaluate the Number of participants with Adverse Events and Serious Adverse Events.Safety will include 5 parameters to be collected for all patients who receive the study regimen which are:

    • Adverse Events
    • Laboratory Assessments
    • Vital Signs
    • Physical Examinations
    • ECG
3 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Tumor marker
Tidsramme: 3 years
  1. The molecular characteristics of circulating tumor cells harvested from peripheral blood
  2. Correlation between the markers of circulating tumor cells and primary tumor.
3 years

Samarbeidspartnere og etterforskere

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

Sponsor

National Guard Health Affairs

Etterforskere

  • Hovedetterforsker: Abdulrahman Jazieh, MD/MPH, King Abdul Aziz Medical City for National Guard

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 2010

Primær fullføring (Faktiske)

1. mai 2013

Studiet fullført (Faktiske)

1. mai 2013

Datoer for studieregistrering

Først innsendt

19. mars 2011

Først innsendt som oppfylte QC-kriteriene

18. mai 2011

Først lagt ut (Anslag)

19. mai 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

22. januar 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. januar 2014

Sist bekreftet

1. januar 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • RC09/095

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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