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Cetuximab, Docetaxel, Cisplatin, and Radiation Therapy in Treating Patients With Locally Advanced Esophageal Cancer That Can Be Removed by Surgery

8. juni 2012 oppdatert av: Swiss Group for Clinical Cancer Research

Cetuximab in Combination With Radiation Therapy and Chemotherapy Prior to Surgery in Patients With Resectable, Locally Advanced Esophageal Carcinoma. A Multicenter Phase IB-II Trial

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab, docetaxel, and cisplatin together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase I/II trial is studying the side effects of cetuximab, docetaxel, cisplatin, and radiation therapy and to see how well they work in treating patients with locally advanced esophageal cancer that can be removed by surgery.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

OBJECTIVES:

Primary

  • Determine the safety of neoadjuvant radiotherapy in combination with cetuximab, docetaxel, and cisplatin in patients with resectable locally advanced esophageal cancer.

Secondary

  • Determine the feasibility and efficacy of this regimen in these patients.
  • Determine the duration of response and patterns of failure in patients treated with this regimen.

OUTLINE: This is a multicenter study.

  • Chemoimmunotherapy: Patients receive cetuximab IV over 1-2 hours once weekly in weeks 1-3 and docetaxel IV over 1 hour and cisplatin IV over 1 hour once in week 1. Treatment repeats every 3 weeks for 2 courses.

  • Chemoimmunotherapy and radiotherapy: Patients are sequentially assigned to 1 of 2 treatment levels.

    • Treatment level 1: Patients receive cetuximab IV over 1 hour once weekly, cisplatin IV over 1 hour once weekly, and undergo radiotherapy once daily, 5 days a week, in weeks 7-11.
    • Treatment level 2: Patients receive cetuximab, cisplatin, and radiotherapy as in treatment level 1. Patients also receive docetaxel IV over 1-2 hours once weekly in weeks 7-11.

Cohorts of 7-20 patients are treated at treatment level 1 or 2 sequentially, as long as no more than 2 of 7 patients experience dose-limiting toxicity (DLT), until the safe treatment level for future study is determined. The safe treatment level is defined as the level at which no more than 2 of 7 and no more than 6 of 20 patients experience DLT. At least 20 patients are treated at the safe treatment level.

  • Surgery: Between 4-8 weeks after completion of neoadjuvant chemoimmunotherapy and radiotherapy, patients undergo surgery.

After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.

Studietype

Intervensjonell

Registrering (Faktiske)

27

Fase

  • Fase 2
  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Sveits
      • St. Gallen, Sveits, CH-9007
        • Kantonsspital - St. Gallen
      • St. Gallen, Sveits, Ch-9016
        • Klinik Stephanshorn

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

18 år til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Histologically confirmed squamous cell carcinoma or adenocarcinoma of the thoracic esophagus

    • Carcinoma of the gastroesophageal junction (i.e., Siewert staging system type I disease) allowed

  • Locally advanced disease

    • Obstructive tumors are considered locally advanced disease

    • Meets 1 of the following staging criteria:

      • T3, N0 disease
      • T1-3, N1 disease
      • T4, N0-1 disease

  • Resectable disease

    • No T4 (unequivocal organ involvement) disease that cannot be resected with curative intent
  • No airway infiltration in case of tumors of the upper third of the thoracic esophagus
  • No cervical esophageal carcinoma
  • No distant metastasis, including stage M1a (celiac node involvement) by fine-needle aspiration or biopsy

PATIENT CHARACTERISTICS:

  • WHO performance status 0-1
  • Creatinine clearance > 60 mL/min
  • Bilirubin normal
  • Alkaline phosphatase ≤ 2.5 times upper limit of normal (ULN)
  • AST ≤ 1.5 times ULN
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 12 months after completion of study treatment
  • No other malignancy within the past 5 years except nonmelanomatous skin cancer or adequately treated in situ cervical cancer

  • No severe or uncontrolled cardiovascular disease including, but not limited to, any of the following:

    • New York Heart Association class III or IV congestive heart failure
    • Unstable angina pectoris
    • Myocardial infarction within the past 3 months
    • Significant arrhythmias
  • No psychiatric disorder that would preclude study compliance
  • No active uncontrolled infection
  • No serious underlying medical condition that, in the opinion of the investigator, would interfere with study participation (e.g., uncontrolled diabetes mellitus or active autoimmune disease)
  • No peripheral neuropathy > grade 1
  • No contraindications to corticosteroids
  • No known hypersensitivity to any component of the study drugs

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy
  • No prior radiotherapy to the chest
  • No participation in another clinical trial within the past 30 days
  • No other concurrent experimental drugs or anticancer therapy
  • No concurrent drugs contraindicated for use with the study drugs

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)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Determine the safety of neoadjuvant radiotherapy in combination with cetuximab, docetaxel, and cisplatin
Tidsramme: Until treatment ends
Determine the safety of neoadjuvant radiotherapy in combination with cetuximab, docetaxel, and cisplatin
Until treatment ends

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Determine the feasibility and efficacy of the study's regimen
Tidsramme: Until trial ends
Determine the feasibility and efficacy of this regimen in these patients.
Until trial ends
Determine the duration of response and patterns of failure
Tidsramme: Until trial ends
Determine the duration of response and patterns of failure in patients treated with this regimen
Until trial ends

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Swiss Group for Clinical Cancer Research

Etterforskere

  • Studiestol: Thomas Ruhstaller, MD, Cantonal Hospital of St. Gallen

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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. januar 2007

Primær fullføring (Faktiske)

1. november 2008

Studiet fullført (Faktiske)

1. november 2008

Datoer for studieregistrering

Først innsendt

7. mars 2007

Først innsendt som oppfylte QC-kriteriene

7. mars 2007

Først lagt ut (Anslag)

9. mars 2007

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

11. juni 2012

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. juni 2012

Sist bekreftet

1. juni 2012

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • SAKK 75/06
  • EU-20702

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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