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Cisplatin and Pemetrexed With Radiation Followed by Lobectomy (CisPemXetSrg)

24. juli 2012 oppdatert av: Medical University of South Carolina

A Phase I Trial of Preoperative Carboplatin or Cisplatin and Pemetrexed With Thoracic Radiation Therapy Followed by Lobectomy in Resectable Stage III Patients With Non-Squamous Non Small Cell Lung Cancer (NSCLC)

This study is open to patients that have been diagnosed with non-squamous Stage III Non Small Cell Lung Cancer (NSCLC) and will have surgery to remove the tumor.

The purpose of this study is to:

  • Test a combination of two chemotherapeutic drugs along with radiation therapy, when given prior to surgery and see what effects (good or bad) it has on someone with this type of cancer. Chemotherapeutic drugs selectively destroy diseased cancer cells and tissues.
  • Test the safety of different dose levels of radiation when given with each combination of chemotherapy;
  • Determine what side effects are associated with combining radiation with these two chemotherapy combinations.

Studieoversikt

Studietype

Intervensjonell

Registrering (Faktiske)

48

Fase

  • Fase 1

Kontakter og plasseringer

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

Studiesteder

    • South Carolina
      • Charleston, South Carolina, Forente stater, 29425
        • Medical University of South Carolina

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 til 90 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Histologically and cytologically confirmed non-squamous NSCLC.
  • Resectable T3, and or N2 disease (T3N1, and resectable T1-3N2 multi-station non-bulky with no nodal station being more than 2 cm on preoperative workup, T4N0-1
  • Resectable T3 includes patients with a satellite lesion in the same lobe as the primary.
  • Male or Female, aged > or = 18 years and be able to give informed consent.
  • Tumor should be technically operable with a lobectomy, bilobectomy or a sleeve resection.
  • Patient should be medically operable
  • ECOG Performance Status 0 or 1.
  • Adequate bone marrow, hepatic and renal function assessed within 28 days
  • Signed informed consent.
  • Women of childbearing potential should have negative pregnancy test prior to enrollment to study.
  • Men with partners in the childbearing age group and women of childbearing potential must use effective contraception while on treatment and for 6 months thereafter.
  • The ability to interrupt NSAIDS 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of Pemetrexed.
  • The ability to take folic acid, Vitamin B12, and dexamethasone according to protocol.
  • Patients must have a negative MRI or CT Scan of the brain.

Exclusion Criteria:

  • Patients who have had chemotherapy or radiation therapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
  • Patients may not be receiving any other investigational agents.
  • History of allergic reactions attributed to compounds or other agents used in study.
  • Pregnant or lactating women.
  • Male patients with female sexual partners in the reproductive age group who refuse to use effective methods of contraception will be excluded from the trial.
  • Patients with concurrent serious infections.
  • Patients with an unstable or serious concurrent medical condition are excluded.
  • Presence of third space fluid which cannot be controlled by drainage.
  • Weight loss > 10 percent from baseline weight.
  • HIV-positive patients on combination antiretroviral therapy are ineligible
  • Patients with hypercalcemia will be excluded.
  • Patients who require a pneumonectomy will be excluded.

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: Ikke-randomisert
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Arm A
  1. Patients will be given the drugs pemetrexed and carboplatin
  2. Radiation
  3. Participants evaluated for response
  4. Lobectomy surgery
Pemetrexed by vein every 21 days for 3 cycles
Carboplatin by vein Every 21 days for 3 cycles
Radiation treatment 5 days a week for 5-6 weeks.
Surgery
Surgery to remove a portion of the lung where the tumor is located.
Eksperimentell: Arm B
  1. Patients will be given the drugs pemetrexed and cisplatin
  2. Radiation
  3. Participants evaluated for response
  4. Lobectomy surgery
Pemetrexed by vein every 21 days for 3 cycles
Radiation treatment 5 days a week for 5-6 weeks.
Surgery
Surgery to remove a portion of the lung where the tumor is located.
Cisplatin by vein every 21 days for 3 cycles

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Safety and tolerability
Determine the safety and tolerability of concurrent chemotherapy with Cisplatin/ Pemetrexed or Carboplatin/Pemetrexed and dose escalated radiation therapy followed by lobectomy.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Response rate, overall survival and progression free survival

Evaluate the following:

  • Response Rate after concurrent chemoradiation therapy.
  • Overall Survival (OS).
  • Progression Free Survival (PFS)

Samarbeidspartnere og etterforskere

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

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 2011

Primær fullføring (Faktiske)

1. juni 2012

Studiet fullført (Faktiske)

1. juni 2012

Datoer for studieregistrering

Først innsendt

13. juni 2011

Først innsendt som oppfylte QC-kriteriene

14. juni 2011

Først lagt ut (Anslag)

15. juni 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

26. juli 2012

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. juli 2012

Sist bekreftet

1. juli 2012

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. .

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