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A Study of Pemetrexed Plus Carboplatin, or Pemetrexed Plus Cisplatin With Radiation Therapy Followed by Pemetrexed in Patients With Inoperable Non-Small-Cell Lung Cancer

26. října 2012 aktualizováno: Eli Lilly and Company

Phase 1/2 Study of Pemetrexed (Alimta) Plus Carboplatin, or Pemetrexed Plus Cisplatin With Concurrent Radiation Therapy Followed by Every-21-Day Pemetrexed Consolidation in Patients With Favorable-Prognosis Inoperable Stage IIIA/B Non-Small-Cell Lung Cancer (NSCLC)

The primary purpose of this study is to determine the 2-year survival rate of both of the chemotherapy regimens in patients with inoperable non-small-cell lung cancer.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

120

Fáze

  • Fáze 2
  • Fáze 1

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Indie
      • Delhi, Indie, 110085
        • 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.
      • Trivandrum, Indie, 695 011
        • 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.
  • Spojené státy
    • California
      • Los Angeles, California, Spojené státy, 90095
        • 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.
    • Kansas
      • Wichita, Kansas, Spojené státy, 67214
        • 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.
    • Missouri
      • St Louis, Missouri, Spojené státy, 63110
        • 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.
    • Nevada
      • Las Vegas, Nevada, Spojené státy, 89135
        • 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.
    • North Carolina
      • Burlington, North Carolina, Spojené státy, 27216
        • 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.
    • Tennessee
      • Memphis, Tennessee, Spojené státy, 38120
        • 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.
    • Texas
      • Corpus Christi, Texas, Spojené státy, 78405
        • 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.
      • Dallas, Texas, Spojené státy, 75390
        • 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.
      • Temple, Texas, Spojené státy, 76508
        • 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.

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • Inoperable non small cell lung cancer
  • No weight loss greater than 10% in 3 months prior to enrolling in trial
  • Adequate kidney function
  • Adequate liver function
  • Adequate lung function

Exclusion Criteria:

  • Previous surgery to remove lung tumor
  • Previous chemotherapy or radiation therapy or lung cancer
  • Inability to take vitamin supplementation
  • Heart attack within past 6 months
  • Active infection

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: A: Pemetrexed + Carboplatin
Pemetrexed + Carboplatin
Lék: pemetrexed

Phase 1 - 500 milligram/meter squared (mg/m²), administered intravenously, every 21 days for 3 cycles

Phase 2 - 500 mg/m², administered intravenously, every 21 days for 3 cycles

Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation therapy for each phase

Ostatní jména:
  • Alimta
  • LY231514
Lék: carboplatin

Phase 1 - dosed at area under the curve (AUC) 2 milligram/milliliter*minute (mg/mL*min), administered intravenously, Days 1, 8, 22, 29 and 43

Phase 2 - dosed at AUC 5 mg/mL*min, administered intravenously, every 21 days for 3 cycles

Záření: radiation therapy

Phase 1 - 2 Gray, daily, 5 days a week for Days 1-51

Phase 2 - 2 Gray, daily, 5 days a week for Days 1-45
Experimentální: B: Pemetrexed + Cisplatin
Pemetrexed + Cisplatin
Lék: pemetrexed

Phase 1 - 500 milligram/meter squared (mg/m²), administered intravenously, every 21 days for 3 cycles

Phase 2 - 500 mg/m², administered intravenously, every 21 days for 3 cycles

Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation therapy for each phase

Ostatní jména:
  • Alimta
  • LY231514
Záření: radiation therapy

Phase 1 - 2 Gray, daily, 5 days a week for Days 1-51

Phase 2 - 2 Gray, daily, 5 days a week for Days 1-45

Lék: cisplatin

Phase 1 - 30 mg/m² and 75 mg/m², administered intravenously, Days 1, 8, 22, 29 and 43

Phase 2 - 75 mg/m², administered intravenously, every 21 days for 3 cycles

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Phase 1 - Maximum Tolerated Dose (MTD) of Carboplatin
Časové okno: Phase 1 enrollment to the end of study treatment up to Week 11
MTD was defined as a dose at which the occurrence of at least 2 dose-limiting toxicities (DLTs) was observed. DLT was defined as any of the following events occurring during the entire radiation therapy (RT) course, including a 2-week recovery period following completion of RT: Grade 4 neutropenia (<0.5 x 10^9 cells per liter) lasting >7 days, febrile neutropenia; ≥Grade 3 neutropenia with fever >38.5 degrees Celsius (°C), Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with ≥Grade 2 bleeding, ≥Grade 3 nonhematologic toxicity (excluding nausea, vomiting, and transaminase elevations) and ≥Grade 3 pulmonary or esophageal toxicity (radiation-related pneumonitis or esophagitis).
Phase 1 enrollment to the end of study treatment up to Week 11
Phase 1 - Maximum Tolerated Dose (MTD) of Cisplatin
Časové okno: Phase 1 enrollment to the end of study treatment up to Week 11
MTD was defined as a dose at which the occurrence of at least 2 dose-limiting toxicities (DLTs) was observed. DLT was defined as any of the following events occurring during the entire radiation therapy (RT) course, including a 2-week recovery period following completion of RT: Grade 4 neutropenia (<0.5 x 10^9 cells per liter) lasting >7 days, febrile neutropenia; ≥Grade 3 neutropenia with fever >38.5 degrees Celsius (°C), Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with ≥Grade 2 bleeding, ≥Grade 3 nonhematologic toxicity (excluding nausea, vomiting, and transaminase elevations) and ≥Grade 3 pulmonary or esophageal toxicity (radiation-related pneumonitis or esophagitis).
Phase 1 enrollment to the end of study treatment up to Week 11
Phase 2 - Survival Probability at 2 Years
Časové okno: Phase 2 randomization up to 2 years
Phase 2 randomization up to 2 years

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Phase 1 - Pharmacology Toxicity: Number of Participants With Dose Limiting Toxicities (DLTs)
Časové okno: Phase 1 enrollment up to Week 11
Phase 1 pharmacology toxicity was defined as the number of participants experiencing dose limiting toxicities (DLTs). DLT was defined as any of the following events occurring during the entire radiation therapy (RT) course: Grade 4 neutropenia (<0.5 x 10^9 cells per liter) >7 days, febrile neutropenia, ≥Grade 3 neutropenia with fever >38.5 degrees Celsius (°C), Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with ≥Grade 2 bleeding, ≥Grade 3 nonhematologic toxicity (excluding nausea, vomiting, and transaminase elevations), and ≥Grade 3 pulmonary or esophageal toxicity (radiation-related pneumonitis or esophagitis). Grade 5 events are the events leading to the death.
Phase 1 enrollment up to Week 11
Phase 1 - Percentage of Participants With Complete Response or Partial Response (Response Rate)
Časové okno: Phase 1 enrollment to the end of the study treatment up to Week 11
Response rate is the percentage of participants with complete response (CR) or partial response (PR), as assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.
Phase 1 enrollment to the end of the study treatment up to Week 11
Phase 2 - Pharmacology Toxicity: Number of Participants With Adverse Events
Časové okno: Phase 2 randomization to the end of the study treatment up to 30.0 months
Phase 2 pharmacology toxicity was defined as the number of participants who experienced serious adverse events or all other nonserious adverse events during the study. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Events section.
Phase 2 randomization to the end of the study treatment up to 30.0 months
Phase 2 - Time to Progression
Časové okno: Phase 2 randomization to measured disease progression up to 24 months
Time to disease progression was measured from randomization of Study Phase 2 to the first observation of disease progression according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Disease progression is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.
Phase 2 randomization to measured disease progression up to 24 months
Phase 2 - Median Survival
Časové okno: Phase 2 randomization to death as the result of any cause up to 30.0 month
Phase 2 randomization to death as the result of any cause up to 30.0 month
Phase 2 - Percentage of Participants With Complete Response or Partial Response (Response Rate)
Časové okno: Phase 2 randomization to the end of the treatment up to 30.0 months
Response rate is the percentage of participants with complete response (CR) or partial response (PR), as assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.
Phase 2 randomization to the end of the treatment up to 30.0 months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Eli Lilly and Company

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. května 2007

Primární dokončení (Aktuální)

1. října 2011

Dokončení studie (Aktuální)

1. října 2011

Termíny zápisu do studia

První předloženo

31. května 2007

První předloženo, které splnilo kritéria kontroly kvality

31. května 2007

První zveřejněno (Odhad)

4. června 2007

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

27. listopadu 2012

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

26. října 2012

Naposledy ověřeno

1. října 2012

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 9031 (CTEP)
  • H3E-US-S047 (Jiný identifikátor: Eli Lilly and Company)

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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