- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00482014
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
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)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
- Fase 1
Contatti e Sedi
Luoghi di studio
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Delhi, India, 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.
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Trivandrum, India, 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.
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California
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Los Angeles, California, Stati Uniti, 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.
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Kansas
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Wichita, Kansas, Stati Uniti, 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.
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Missouri
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St Louis, Missouri, Stati Uniti, 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.
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Nevada
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Las Vegas, Nevada, Stati Uniti, 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.
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North Carolina
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Burlington, North Carolina, Stati Uniti, 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.
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Tennessee
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Memphis, Tennessee, Stati Uniti, 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.
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Texas
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Corpus Christi, Texas, Stati Uniti, 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.
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Dallas, Texas, Stati Uniti, 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.
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Temple, Texas, Stati Uniti, 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.
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: A: Pemetrexed + Carboplatin
Pemetrexed + Carboplatin
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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
Altri nomi:
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 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 |
Sperimentale: B: Pemetrexed + Cisplatin
Pemetrexed + Cisplatin
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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
Altri nomi:
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 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 |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Phase 1 - Maximum Tolerated Dose (MTD) of Carboplatin
Lasso di tempo: Phase 1 enrollment to the end of study treatment up to Week 11
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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).
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Phase 1 enrollment to the end of study treatment up to Week 11
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Phase 1 - Maximum Tolerated Dose (MTD) of Cisplatin
Lasso di tempo: Phase 1 enrollment to the end of study treatment up to Week 11
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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).
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Phase 1 enrollment to the end of study treatment up to Week 11
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Phase 2 - Survival Probability at 2 Years
Lasso di tempo: Phase 2 randomization up to 2 years
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Phase 2 randomization up to 2 years
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Phase 1 - Pharmacology Toxicity: Number of Participants With Dose Limiting Toxicities (DLTs)
Lasso di tempo: Phase 1 enrollment up to Week 11
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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.
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Phase 1 enrollment up to Week 11
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Phase 1 - Percentage of Participants With Complete Response or Partial Response (Response Rate)
Lasso di tempo: Phase 1 enrollment to the end of the study treatment up to Week 11
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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.
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Phase 1 enrollment to the end of the study treatment up to Week 11
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Phase 2 - Pharmacology Toxicity: Number of Participants With Adverse Events
Lasso di tempo: Phase 2 randomization to the end of the study treatment up to 30.0 months
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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.
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Phase 2 randomization to the end of the study treatment up to 30.0 months
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Phase 2 - Time to Progression
Lasso di tempo: Phase 2 randomization to measured disease progression up to 24 months
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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.
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Phase 2 randomization to measured disease progression up to 24 months
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Phase 2 - Median Survival
Lasso di tempo: Phase 2 randomization to death as the result of any cause up to 30.0 month
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Phase 2 randomization to death as the result of any cause up to 30.0 month
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Phase 2 - Percentage of Participants With Complete Response or Partial Response (Response Rate)
Lasso di tempo: Phase 2 randomization to the end of the treatment up to 30.0 months
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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.
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Phase 2 randomization to the end of the treatment up to 30.0 months
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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie delle vie respiratorie
- Neoplasie
- Malattie polmonari
- Neoplasie per sede
- Neoplasie delle vie respiratorie
- Neoplasie toraciche
- Carcinoma, broncogeno
- Neoplasie bronchiali
- Neoplasie polmonari
- Carcinoma, polmone non a piccole cellule
- Meccanismi molecolari dell'azione farmacologica
- Inibitori della sintesi degli acidi nucleici
- Inibitori enzimatici
- Agenti antineoplastici
- Antagonisti dell'acido folico
- Carboplatino
- Pemetrexed
Altri numeri di identificazione dello studio
- 9031 (CTEP)
- H3E-US-S047 (Altro identificatore: Eli Lilly and Company)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Cancro polmonare non a piccole cellule
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National Cancer Institute (NCI)ReclutamentoKita-kyushu Lung Cancer Antigen 1, umanoStati Uniti
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National Cancer Institute (NCI)NCIC Clinical Trials Group; Southwest Oncology Group; Cancer and Leukemia Group BCompletatoCarcinoma a cellule renali a cellule chiare | Cancro a cellule renali in stadio III AJCC v7 | Cancro a cellule renali in stadio II AJCC v7 | Stadio I Renal Cell Cancer AJCC v6 e v7Stati Uniti, Canada, Porto Rico
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National Cancer Institute (NCI)TerminatoCarcinoma a cellule renali a cellule chiare | Carcinoma a cellule renali metastatico | Cancro a cellule renali in stadio III AJCC v7 | Cancro a cellule renali in stadio IV AJCC v7 | Cancro a cellule renali in stadio II AJCC v7 | Stadio I Renal Cell Cancer AJCC v6 e v7Stati Uniti
Prove cliniche su pemetrexed
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Boehringer IngelheimTerminatoCarcinoma, polmone non a piccole celluleGiappone
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Rongjie TaoNational Natural Science Foundation of ChinaSconosciutoMetastasi cerebraliCina
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Northwestern UniversityNational Cancer Institute (NCI)SconosciutoLinfoma | Tumori cerebrali e del sistema nervoso centrale | Cancro metastaticoStati Uniti
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Eli Lilly and CompanyCompletatoCancro polmonare non a piccole cellule metastatico | Neoplasia polmonare non a piccole cellule non squamosa | Carcinoma polmonare non a piccole cellule stadio IIIBRegno Unito, Svezia
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PfizerTerminatoCarcinoma, polmone non a piccole celluleStati Uniti, Germania, Italia
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Norwegian University of Science and TechnologySt. Olavs HospitalTerminatoCarcinoma, polmone non a piccole celluleNorvegia
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Ain Shams UniversitySconosciuto
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The First Affiliated Hospital with Nanjing Medical...SconosciutoCarcinoma polmonare non a piccole cellule non squamoso
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Spanish Lung Cancer GroupTerminatoCarcinoma, polmone non a piccole celluleSpagna
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Threshold PharmaceuticalsEMD SeronoTerminatoCarcinoma polmonare non a piccole celluleStati Uniti, Germania, Spagna, Polonia, Grecia, Cechia, Ungheria, Italia, Romania, Federazione Russa