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Cisplatin and Pemetrexed With Radiation Followed by Lobectomy (CisPemXetSrg)

24. juli 2012 opdateret af: 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.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

48

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Medical University of South Carolina

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 til 90 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

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
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Eksperimentel: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
Response rate, overall survival and progression free survival

Evaluate the following:

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

Samarbejdspartnere og efterforskere

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

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 2011

Primær færdiggørelse (Faktiske)

1. juni 2012

Studieafslutning (Faktiske)

1. juni 2012

Datoer for studieregistrering

Først indsendt

13. juni 2011

Først indsendt, der opfyldte QC-kriterier

14. juni 2011

Først opslået (Skøn)

15. juni 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. juli 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. juli 2012

Sidst verificeret

1. juli 2012

Mere information

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 .

Kliniske forsøg med Pemetrexed

Abonner