- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00906282
Preoperative Pemetrexed and Carboplatin for Select Stage IB, II, and III Non-Squamous Non-Small-Cell Lung Cancer
5. januar 2017 oppdatert av: SCRI Development Innovations, LLC
Phase II Trial of Preoperative Pemetrexed and Carboplatin in Patients With Select Stage IB, II, and III Non-Squamous Non-Small-Cell Lung Cancer
The purpose of this multi-center Phase II trial is to examine the impact of pemetrexed/carboplatin in the preoperative treatment of patients with select stage IB, II,and III non-squamous NSCLC.
Because patients with non-squamous type NSCLC have been shown to have better survival rates than patients with squamous tumors when given pemetrexed with a platinum agent, only patients with non-squamous NSCLC (adenocarcinoma, large cell, and undifferentiated), not including squamous histology, will be allowed to participate in this study.
If this novel regimen proves to be safe and active in this setting, it will provide rationale for further investigation in a larger, prospective, randomized trial.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
46
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Florida
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Fort Myers, Florida, Forente stater, 33901
- Florida Cancer Specialists
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Georgia
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Augusta, Georgia, Forente stater, 30901
- Medical Oncology Associates of Augusta
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Gainesville, Georgia, Forente stater, 30501
- Northeast Georgia Medical Center
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Kentucky
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Louisville, Kentucky, Forente stater, 40207
- Baptist Hospital East
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Maryland
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Bethesda, Maryland, Forente stater, 20817
- Center For Cancer And Blood Disorders
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Bethesda, Maryland, Forente stater, 20817
- National Capital Clinical Research Consortium
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Nebraska
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Omaha, Nebraska, Forente stater, 68114
- Nebraska Methodist Cancer Center
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Ohio
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Cincinnati, Ohio, Forente stater, 45242
- Oncology Hematology Care
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South Carolina
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Columbia, South Carolina, Forente stater, 29210
- South Carolina Oncology Associates, PA
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Tennessee
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Chattanooga, Tennessee, Forente stater, 37404
- Chattanooga Oncology Hematology Associates
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Nashville, Tennessee, Forente stater, 37023
- Tennessee Oncology, PLLC
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Virginia
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Richmond, Virginia, Forente stater, 23235
- Virginia Cancer Institute
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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
16 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Histologically-confirmed NSCLC (adenocarcinoma, large cell, and undifferentiated). Patients with squamous histology are not eligible.
- Life expectancy of at least 12 weeks.
Patients with the following stages of NSCLC:
- T2 N0 tumors: Limited to tumors >=4 cm.
- T1-2 N1 tumors.
- T3 N0-1 tumors (excluding superior sulcus tumors): Including tumors involving the chest wall, proximal airway, or mediastinal pleura where preoperative radiotherapy is not planned.
- T1-2 N2 tumors: For patients with N2 disease involving one zone (Upper zone (R), AP zone (L), subcarinal zone, or lower zone) and nodes <=2cm in diameter.
- T4 N0-1 tumors (excluding superior sulcus tumors): T4 lesions other than malignant effusions where radiotherapy is not planned.
- Patients with clinical N2 involvement must have histologic confirmation by mediastinoscopy (or alternate biopsy procedure).
- Tumors should be considered potentially resectable.
- No evidence of extrathoracic metastatic disease.
- Patients must have measurable disease by RECIST criteria.
- Patients must be candidates (medically) for chemotherapy followed by surgical resection.
- Adequate recovery from recent surgery. At least 1 week must have elapsed from the time of a minor surgery; at least 3 weeks must have elapsed from the time of a major surgery.
Laboratory values as follows:
- Absolute neutrophil count (ANC) >=1500/μL
- Hemoglobin (Hgb) >=10 g/dL
- Platelets >=100,000/uL
- AST/SGOT and ALT/SGPT within normal limits (WNL)
- Total bilirubin within normal limits (WNL)
- Calculated creatinine clearance >=45 mL/min
- ECOG Performance Status grade 0 or 1.
- The ability to interrupt NSAIDS 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of Alimta.
- The ability to take folic acid, Vitamin B12, and dexamethasone according to protocol.
- Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to start of treatment. Women of childbearing potential or men with partners of childbearing potential must use effective birth control measures during treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.
- Patient must be accessible for treatment and follow-up.
- Patients must be able to understand the investigational nature of this study and give written informed consent prior to study entry.
Exclusion Criteria:
Patients with the following stages are excluded:
- T1 N0;
- T2 N0, with primary tumor <4 cm;
- T1-2 N2, with multiple zones of N2 involvement;
- T3-4 N2;
- Any N3;
- Any TxNxM1 disease; or
- Any stage where surgery and/or chemoradiotherapy is the preferred initial approach in management, as deemed by the treating physician.
- Squamous or predominant squamous mixed histologies.
- Mixed small-cell and non-small cell histologies.
- Pulmonary carcinoid tumors.
- Presence of third space fluid which cannot be controlled by drainage.
- Use of erythropoietin as a hematopoietic growth factor is not allowed.
- Cardiac disease, including: congestive heart failure (CHF) > Class II per New York Heart Association (NYHA) classification; unstable angina (anginal symptoms at rest) or new-onset angina (i.e., began within the last 3 months), or myocardial infarction within the past 6 months; symptomatic CHF, unstable angina pectoris, cardiac arrhythmia, or cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
- Women who are pregnant (positive pregnancy test) or lactating.
- Use of any non-approved or investigational agent within 30 days of administration of the first dose of study drug.
- Patients may not receive any other investigational or anti-cancer treatments while participating in this study.
- Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
- Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.
- History of hypersensitivity to active or inactive excipients of any component of treatment.
- Inability to comply with study and/or follow-up procedures.
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: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Pemetrexed/Carboplatin
4 cycles of preoperative treatment (1 Cycle = 21 days): Pemetrexed: 500 mg/m2 intravenously (IV) for 10 minutes on Day 1 each cycle; Carboplatin: AUC 6.0 by IV on Day 1 each cycle. |
500 mg/m2 IV over 10 minutes on Day 1 of every 3-week treatment cycle for a total of 4 cycles (12 weeks).
Andre navn:
AUC 6.0 IV on Day 1 of every 3-week treatment cycle for a total of 4 cycles (12 weeks).
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
3-Year Overall Survival Rate
Tidsramme: 36 months
|
The percentage of patients who were alive at 3 years from time of first study treatment until date of death from any cause.
Overall survival is shown for the Intent-to-Treat population.
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36 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Objective Tumor Response
Tidsramme: At 6 and 12 weeks
|
Objective Tumor Response defined as the percent of patients who completed up to 4 cycles of pre-operative chemotherapy and achieved a complete response (CR) or partial response (PR) assessed by Response Evaluation in Solid Tumors (RECIST) 1.0.
Patients with stable disease (SD) or response to treatment were deemed surgical candidates.
[CR=disappearance of all target tumors; PR= ≥30% decrease in the sum of the longest diameters of target tumors.
SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.]
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At 6 and 12 weeks
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Pathologic Response Rate
Tidsramme: weeks 15 -18
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Percent of patients having a pathological complete or partial response (pCR or pPR) at surgery.
pCR defined as complete removal of all tumor.
pPR defined as residual viable tumor demonstrated in the resected specimen.
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weeks 15 -18
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Rate of Residual Disease as an Assessment of Pathological Partial Response (pPR)
Tidsramme: At 15-18 weeks
|
pPR was further assessed by the amount of residual tumor measured at surgery: microscopic residual disease = less than 1 centimeter (<1 cm); macroscopic residual disease = 1 centimeter or greater (≥1 cm).
|
At 15-18 weeks
|
Complete Resection Rate
Tidsramme: At weeks 15-18
|
The percent of patients who had surgical resection listed by procedure type: lobectomy or pneumonectomy, or resection of adjacent chest wall or mediastinal structures when appropriate.
Surgery followed standard guidelines for resection of non-small-cell lung cancer (NSCLC).
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At weeks 15-18
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Studiestol: David R Spigel, M.D., SCRI Development Innovations, LLC
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. juni 2009
Primær fullføring (Faktiske)
1. august 2015
Studiet fullført (Faktiske)
1. september 2015
Datoer for studieregistrering
Først innsendt
19. mai 2009
Først innsendt som oppfylte QC-kriteriene
20. mai 2009
Først lagt ut (Anslag)
21. mai 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. februar 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. januar 2017
Sist bekreftet
1. januar 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i luftveiene
- Neoplasmer
- Lungesykdommer
- Neoplasmer etter nettsted
- Neoplasmer i luftveiene
- Thoracale neoplasmer
- Karsinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Karsinom, ikke-småcellet lunge
- Molekylære mekanismer for farmakologisk virkning
- Nukleinsyresyntesehemmere
- Enzymhemmere
- Antineoplastiske midler
- Folsyreantagonister
- Karboplatin
- Pemetrexed
Andre studie-ID-numre
- SCRI LUN 186
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
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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