Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Study of Cetuximab With Radiation Followed by Consolidation Chemotherapy for NSCLC

7. Dezember 2016 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

40

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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
Arzneimittel: 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.
Andere Namen:
  • Erbitux, C225

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Gesamtüberleben (OS)
Zeitfenster: Bis zu 36 Monate
Bis zu 36 Monate

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Progression-free Survival (PFS)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: approx. 5 years
EGFR (epidermal growth factor receptor) gene mutation status and Akt, pAkt, and MAPKinase in participant tumor tissue.
approx. 5 years

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Pittsburgh

Mitarbeiter

Bristol-Myers Squibb

Ermittler

  • Hauptermittler: Athanassios Argiris, MD, University of Pittsburgh

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juni 2006

Primärer Abschluss (Tatsächlich)

1. Februar 2012

Studienabschluss (Tatsächlich)

1. Februar 2012

Studienanmeldedaten

Zuerst eingereicht

26. Juni 2007

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

26. Juni 2007

Zuerst gepostet (Schätzen)

27. Juni 2007

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

1. Februar 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. Dezember 2016

Zuletzt verifiziert

1. Dezember 2016

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 05-106
  • NCT00492206 (Registrierungskennung: ClinicalTrials.gov)

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren