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Chemotherapy With Pemetrexed in Combination With Platinum for Advanced Non-Small Cell Lung Cancer (NSCLC)

1 februari 2010 bijgewerkt door: Eli Lilly and Company

A Randomized Phase 2 Study of Pemetrexed in Combination With Cisplatin or Carboplatin in the First Line Therapy of Advanced NSCLC

This is a two-arm, parallel, open-label, Phase 2 multicenter study of pemetrexed as first line combination therapy with either cisplatin or carboplatin in the palliative setting of stage IIIb and IV non-small cell lung cancer patients. Approximately 130 patients will be included in about 15 centers in Germany and randomized to one of the above treatment regimens in a 1:1 ratio. Chemotherapy will be administered over a maximum of six cycles with a standard length of 21 days. Primary objective will be the Progression Free Survival Time of patients as assessed in both treatment arms.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

133

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Duitsland
      • Coswig, Duitsland, D-01640
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Frankfurt, Duitsland, 65929
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Großhansdorf, Duitsland, D-22927
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Halle, Duitsland, D-06120
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Hamburg, Duitsland, D-21075
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Hofheim, Duitsland, D-65719
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Homburg/Saar, Duitsland, 66421
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Immenhausen, Duitsland, D-34376
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Leipzig, Duitsland, 04207
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Luebeck, Duitsland, 23538
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Mainz, Duitsland, 55131
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Muenchen, Duitsland, 81664
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Cytologically and/or histologically confirmed NSCLC Stage IIIb or IV
  • No previous systemic chemotherapy for this cancer
  • At least one uni-dimensionally measurable lesion meeting Response Evaluation Criteria In Solid Tumors (RECIST) criteria
  • Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1 and adequate organ function
  • Prior radiation therapy allowed but limited to <25% of the patient's bone marrow

Exclusion Criteria:

  • Serious concomitant systemic disorder or active infection
  • Mild to moderate renal insufficiency, but unable to interrupt salicylates or other nonsteroidal anti-inflammatory drugs
  • Symptomatic central nervous system (CNS) metastases requiring concurrent corticosteroid therapy
  • Presence of clinically significant third-space fluid collections

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Pemetrexed + Carboplatine
Geneesmiddel: Pemetrexed
500 mg/m2, intravenous (IV), every 21 days x 6 cycles
Andere namen:
  • Alimta
  • LY231514
Geneesmiddel: Carboplatin
Area under the concentration curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
Experimenteel: Pemetrexed + cisplatine
Geneesmiddel: Pemetrexed
500 mg/m2, intravenous (IV), every 21 days x 6 cycles
Andere namen:
  • Alimta
  • LY231514
Geneesmiddel: Cisplatin
75 mg/m2, intravenous (IV), every 21 days x 6 cycles

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants Surviving Progression-Free at 6 Months (Progression Free Survival [PFS] Rate)
Tijdsspanne: Randomization to Month 6
For this study, we used the exponential distribution (assumption done for the calculation of the sample size) to estimate the PFS rate. The PFS rate (%) and the 95% confidence intervals were calculated based on the following formula: exp(-6 λ) ± 1.96 * exp(-6 λ) * (-6 λ)/√r. Where λ was calculated based on the Maximum-Likelihood estimator for ln(λ) as given by (Collett 2003): ln(λ) = ln[ r / ∑ti ] with r = number of patients with events up to 6 months, ti = survival time of patient i (i=1,…,n), event or censored up to 6 months, and n= total number of patients per treatment group.
Randomization to Month 6

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall Survival
Tijdsspanne: Randomization to date of death from any cause (up to 1 year)
Defined as the time from randomization to the date of death from any cause.
Randomization to date of death from any cause (up to 1 year)
Number of Participants With Tumor Response (as Basis for Response Rate)
Tijdsspanne: Every 6 weeks for 6 months during the treatment period, and every 3 months during the follow-up period, until disease progression
Best overall response was evaluated using RECIST Criteria which define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatment. CR: complete response, disappearance of all target lesions; PR: partial response, 30% decrease in sum of the longest diameter of target lesions; PD: progressive disease, 20% increase in sum of the longest diameter of target lesions; SD: stable disease, small changes not meeting above criteria. Response Rate: number of participants with response(CR+PR)per total population, multiplied by 100 to give a percentage.
Every 6 weeks for 6 months during the treatment period, and every 3 months during the follow-up period, until disease progression
Time to Treatment Failure (TTF)
Tijdsspanne: Randomization to stopping of treatment, progression, death or initiation of further chemotherapy, whichever occurs first (up to 1 year)
Defined as time from randomization to the first date of disease progression, death due to any cause, or early discontinuation of treatment (any reason), whichever occurred first
Randomization to stopping of treatment, progression, death or initiation of further chemotherapy, whichever occurs first (up to 1 year)
Pharmacology Toxicities
Tijdsspanne: Every 21-day cycle for up to 6 cycles
Number of patients experiencing Grade 3 or 4 hematologic and non-hematologic adverse events (AEs) possibly related to study drug or protocol procedures in this study (a subset of those listed in the AE Module). AEs were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death). Grade 3 AEs are severe and undesirable; Grade 4 AEs are life-threatening or disabling.
Every 21-day cycle for up to 6 cycles

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Eli Lilly and Company

Onderzoekers

  • Studie directeur: Call 1-877-CTLilly (1-877-285-4559) or 1-317-615-4559 Mon -Fri 9 AM - 5 PM Eastern time (UTC/GMT -5 hours EST), Eli Lilly and Company

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 november 2006

Primaire voltooiing (Werkelijk)

1 december 2008

Studie voltooiing (Werkelijk)

1 mei 2009

Studieregistratiedata

Eerst ingediend

17 november 2006

Eerst ingediend dat voldeed aan de QC-criteria

17 november 2006

Eerst geplaatst (Schatting)

22 november 2006

Updates van studierecords

Laatste update geplaatst (Schatting)

17 februari 2010

Laatste update ingediend die voldeed aan QC-criteria

1 februari 2010

Laatst geverifieerd

1 februari 2010

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 11077 (DAIDS ES Registry Number)
  • H3E-SB-S109 (Andere identificatie: Eli Lilly and Company)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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CROs in Finland

Voorwaarden

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Geneesmiddelinterventies

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Locaties

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