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Study of Cetuximab With Radiation Followed by Consolidation Chemotherapy for NSCLC

7 dicembre 2016 aggiornato da: Ahmad Tarhini, University of Pittsburgh

A Phase II Study of Cetuximab in Combination With External Beam Radiation Followed By Consolidation Chemotherapy for Patients With Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

This is an open label, phase II study in which cetuximab with concurrent thoracic radiotherapy followed by consolidation chemotherapy with paclitaxel/carboplatin/cetuximab will be administered to subjects with locally advanced NSCLC.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This is a Phase II study to determine the overall survival for patients with locally advanced NSCLC treated with cetuximab with concurrent thoracic radiotherapy followed by consolidation chemotherapy with paclitaxel/carboplatin/cetuximab. This is a multicenter study including 36 subjects who will be males and females, both greater than 18 years of age. All subjects will initially receive radiation and cetuximab. Radiation will be given once a day (Monday-Friday) for approximately 6-8 weeks. During the course of radiation, cetuximab will be given intravenously once a week. Approximately 4-6 weeks after the last radiation dose, the subjects will be treated with chemotherapy, paclitaxel/carboplatin. Chemotherapy will be given intravenously once every 3 weeks for 3 cycles (1 cycle=3 weeks). Cetuximab intravenous administration will be continued throughout the entire study, once a week through week 26 including during chemotherapy.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

40

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Florida
      • Miami, Florida, Stati Uniti, 33136
        • Sylvester Comprehensive Cancer Center, University of Miami
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30322
        • Emory Winship Cancer Institute
    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21231
        • Sidney Kimmel Comprehensive Cancer Center at John Hopkins
    • Ohio
      • Steubenville, Ohio, Stati Uniti, 43952
        • UPMC Cancer Center -Teramana Cancer Center
    • Pennsylvania
      • Beaver, Pennsylvania, Stati Uniti, 15009
        • UPMC Cancer Center -Beaver
      • Clairton, Pennsylvania, Stati Uniti, 15025
        • UPMC Cancer Center - Clairton
      • Greensburg, Pennsylvania, Stati Uniti, 15601
        • UPMC Cancer Center - Oakbrook Commons
      • Greensburg, Pennsylvania, Stati Uniti, 15601
        • UPMC Cancer Center -Arnold Palmer Pavilion
      • Hershey, Pennsylvania, Stati Uniti, 17033
        • Penn State Cancer Institute, Penn State Milton S. Hershey Medical Center
      • Indiana, Pennsylvania, Stati Uniti, 15701
        • UPMC Cancer Center -Indiana
      • Johnstown, Pennsylvania, Stati Uniti, 15901
        • UPMC Cancer Center -John P. Murtha Pavilion
      • McKeesport, Pennsylvania, Stati Uniti, 15132
        • UPMC Cancer Center -McKeesport
      • Monroeville, Pennsylvania, Stati Uniti, 15146
        • UPMC Cancer Center -Haymaker Rd.
      • Monroeville, Pennsylvania, Stati Uniti, 15146
        • UPMC Cancer Center -Mosside Blvd.
      • Moon Township, Pennsylvania, Stati Uniti, 15108
        • UPMC Cancer Center -Sewickley Medical Center
      • Mt. Pleasant, Pennsylvania, Stati Uniti, 15666
        • UPMC Cancer Center -Mt. Pleasant
      • New Castle, Pennsylvania, Stati Uniti, 16105
        • UPMC Cancer Center -Jameson
      • New Castle, Pennsylvania, Stati Uniti, 16105
        • UPMC Cancer Center -New Castle
      • Pittsburgh, Pennsylvania, Stati Uniti, 15213
        • UPMC Presbyterian -Radiation Oncology
      • Pittsburgh, Pennsylvania, Stati Uniti, 15215
        • UPMC Cancer Center -Delafield Rd.
      • Pittsburgh, Pennsylvania, Stati Uniti, 15215
        • UPMC Cancer Center -St. Margaret
      • Pittsburgh, Pennsylvania, Stati Uniti, 15232
        • Universtity of Pittsburgh Cancer Institute -Hillman Cancer Center
      • Pittsburgh, Pennsylvania, Stati Uniti, 15232
        • UPMC Cancer Center -UPMC Shadyside
      • Pittsburgh, Pennsylvania, Stati Uniti, 15237
        • UPMC Cancer Center -Passavant
      • Pittsburgh, Pennsylvania, Stati Uniti, 15241
        • UPMC Cancer Center -Drake
      • Pittsburgh, Pennsylvania, Stati Uniti, 15243
        • UPMC Cancer Center -St. Clair
      • Seneca, Pennsylvania, Stati Uniti, 16346
        • UPMC Cancer Center -UPMC Northwest
      • Uniontown, Pennsylvania, Stati Uniti, 15401
        • UPMC Cancer Center -Robert Eberly Pavilion
      • Uniontown, Pennsylvania, Stati Uniti, 15401
        • UPMC Cancer Center -Uniontown
      • Washington, Pennsylvania, Stati Uniti, 15301
        • UPMC Cancer Center -Washington
      • Wexford, Pennsylvania, Stati Uniti, 15090
        • UPMC Cancer Center -Wexford

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed diagnosis of non-small cell lung cancer
  • Patients must have surgically unresectable stage IIIA disease or stage IIIB disease without malignant pleural/pericardial effusion
  • Patients must have measurable disease as per the RECIST criteria, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan. See section 9.2 for the evaluation of measurable disease.
  • Age >18 years. Lung cancer is extremely rare in children.
  • ECOG performance status 0-1 (Karnofsky >70%; see Appendix A).
  • If available, tumor tissue should be submitted for EGFR status by IHC and correlative studies.
  • Patients must have normal organ and marrow function as defined below:
  • leukocytes >3,000/μL
  • absolute neutrophil count >1,500/μL
  • platelets >100,000/μL
  • total bilirubin within normal institutional limits
  • AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal
  • creatinine within normal institutional limits OR
  • creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
  • The effects of cetuximab on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because EGFR inhibitors, chemotherapeutic agents and radiation therapy, as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Patients must either be not of child bearing potential or have a negative pregnancy test within 7 days of treatment. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
  • Willingness to sign an approved informed consent.

Exclusion Criteria:

  • Patients should not have received prior chest radiation therapy.
  • Patients with a history of pulmonary fibrosis are excluded from study.
  • Patients may not be receiving any other investigational agents.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin, paclitaxel, cetuximab or other agents used in the study.
  • History of any cancer other than NSCLC (except non-melanoma skin cancer or carcinoma in situ of the cervix) within the last five years.
  • Prior therapy with known specific inhibitors of the EGFR.
  • History of severe allergic reaction to prior therapy with monoclonal antibodies
  • Peripheral neuropathy of more than grade 1 in severity
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, significant history of uncontrolled cardiac disease ie. uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure,and cardiomyopathy with decreased ejection fraction, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant women are excluded from this study because carboplatin, paclitaxel, cetuximab and radiation therapy have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the above agents, breastfeeding should be discontinued if the mother is treated with the agents used in this study. These potential risks may also apply to other agents used in this study.
  • Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy. Therefore, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with carboplatin, paclitaxel and cetuximab or other agents administered during the study. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.
  • Active hepatitis.
  • History of pulmonary fibrosis.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Cetuximab

Cetuximab 400 mg/m2 IV week 0 only

External beam radiation weeks 1 - 7

Cetuximab 250 mg/m2 IV weekly thereafter weeks 1 - 7

Cetuximab 250 mg/m2 IV weekly weeks 8 - 26

Carboplatin AUC = 6 IV Paclitaxel 200 mg/m2 IV Every 3 weeks x 3 Cycles
Droga: Cetuximab
The initial dose of cetuximab is 400 mg/m2 intravenously administered over 120 minutes, followed by weekly infusions at 250 mg/m2 IV over 60 minutes. Subjects will receive cetuximab from week 0 through week 26.
Altri nomi:
  • Erbitux, C225

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Sopravvivenza globale (OS)
Lasso di tempo: Fino a 36 mesi
Fino a 36 mesi

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression-free Survival (PFS)
Lasso di tempo: Up to 36 months
Response and progression were evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]. Progressive Disease was defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Up to 36 months
Best Overall Response Rate (ORR) (Number of Participants)
Lasso di tempo: Up to 12 weeks after treatment initiation
The Best Overall Response is the best response (Complete Response, Partial Response, Stable Disease, Progressive Disease) recorded from the start of the study treatment until the disease progression/recurrence at end of study. Response and progression were evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]. Complete Response (CR) is the Disappearance of all target lesions and Partial Response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Up to 12 weeks after treatment initiation
EGFR (Epidermal Growth Factor Receptor) Gene Mutation and Akt, pAkt, and MAPKinase
Lasso di tempo: approx. 5 years
EGFR (epidermal growth factor receptor) gene mutation status and Akt, pAkt, and MAPKinase in participant tumor tissue.
approx. 5 years

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Pittsburgh

Collaboratori

Bristol-Myers Squibb

Investigatori

  • Investigatore principale: Athanassios Argiris, MD, University of Pittsburgh

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 giugno 2006

Completamento primario (Effettivo)

1 febbraio 2012

Completamento dello studio (Effettivo)

1 febbraio 2012

Date di iscrizione allo studio

Primo inviato

26 giugno 2007

Primo inviato che soddisfa i criteri di controllo qualità

26 giugno 2007

Primo Inserito (Stima)

27 giugno 2007

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

1 febbraio 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 dicembre 2016

Ultimo verificato

1 dicembre 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 05-106
  • NCT00492206 (Identificatore di registro: ClinicalTrials.gov)

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 .

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