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Pre-operation Chemo and Antibody Therapy Followed by Surgical Resection and Adjuvant Chemoradiation for Gastric Cancer

6. november 2015 oppdatert av: NYU Langone Health

Neoadjuvant Therapy of Gastric Cancer With Irinotecan, Cisplatin and Cetuximab Followed by Surgical Resection and Adjuvant Chemoradiation

This study intends to evaluate the feasibility and treatment efficacy of adding an antibody blocking the epidermal growth factor (EGF) pathway to a neoadjuvant approach with proven efficacy developed at New York University.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The overall objective of this study is the development of definitive treatments for patients with locally advanced gastric cancer. To this end, this trial is evaluating the feasibility and treatment efficacy of adding an antibody blocking the EGF pathway to a neoadjuvant approach with proven efficacy developed at New York University (NYU). The combination of Irinotecan and Cisplatin has been shown to be synergistic and active against gastric carcinoma. This trial therefore builds upon NYU previous experience with the neoadjuvant administration of Irinotecan combined with Cisplatin as well as the reported enhanced activity of Irinotecan, Cisplatin and External beam radiation when combined with Cetuximab to develop a novel neoadjuvant and adjuvant approach for the treatment of gastric and gastro-esophageal junction (GEJ) cancers. The program includes: 1) systemic combination of Irinotecan, Cisplatin and Cetuximab used as an induction, 2) followed by potentially curative gastrectomy or GEJ resection, and 3) post-operative chemoradiation as reported in the Intergroup study with the addition of Cetuximab.

Studietype

Intervensjonell

Registrering (Faktiske)

30

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • New York
      • New York, New York, Forente stater, 10016
        • NYU Cancer Center

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 og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Patients must have signed an approved informed consent.
  • must have histologically documented untreated gastric/GEJ carcinoma (clinical stage T3 N0 or T4, or any T with N1-N3 M0)
  • Patients with tumor tissue available for assessment of EGF receptor status by immuno-histochemistry (IHC).
  • Patients with Performance Status 0-2.
  • Patients, 18 years and older, 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.
  • Bone marrow function: absolute neutrophil count (ANC) at least 1,500/ul; platelets at least 100,000/ul.
  • Renal function: creatinine not greater than 1.5 x institutional upper limit of normal (ULN).
  • The PT and PTT should be within the range of normal values
  • Hepatic function: bilirubin not greater than 1.5 x ULN; aspartate aminotransferase (AST) not greater than 2.5 x ULN.

Exclusion Criteria:

  • Acute hepatitis or known HIV.
  • Active or uncontrolled infection.
  • Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, and congestive heart failure.
  • Prior therapy that affects or targets the EGF pathway.
  • Prior allergic reaction to chimerized or murine monoclonal antibody therapy or documented presence of human anti-mouse antibodies (HAMA).
  • Any concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s).

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: Induction/ surgery/ chemoRT
  1. Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.
  2. Surgery (starts 3-4 weeks after induction treatment).
  3. Chemoradiation treatment (starts 4-6 weeks after surgery):

weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days
Legemiddel: Cetuximab
Andre navn:
  • Erbitux
Legemiddel: Cisplatin
Andre navn:
  • Platinol-AQ
Fremgangsmåte: Kirurgi
Legemiddel: Irinotekan
Andre navn:
  • Camptosar
  • CPT-11
Stråling: Stråling
Legemiddel: 5-FU
Andre navn:
  • Fluorourocil

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Clinical Response Rate of an Induction Regimen Consisting of Irinotecan, Cisplatin and Cetuximab
Tidsramme: 4 months from the beginning of the induction regimen
Clinical response rate is defined as the percentage of patients who responded to the induction regimen. The response is determined based on endoscopic ultrasonography (EUS) staging pre-treatment and post-treatment, CT scans pre- and post- operatively, and initial clinical stage (based on these tests) compared with the pathologic stage. Any "down-staging" of T or N stage is considered to be a result of induction therapy and counted as a clinical response.
4 months from the beginning of the induction regimen

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Rate of Clearance of Nodal Involvement Among Patients Who Have Received the Induction Therapy
Tidsramme: 4 months from the beginning of the induction treatment
This is defined as the percentage of patients whose nodal involvement of cancer has been cleared based on surgery results.
4 months from the beginning of the induction treatment
Rate of Potentially Curative Surgery
Tidsramme: 4 months from the beginning of the induction treatment
This is defined as the percentage of patients who underwent curative surgery (surgery to remove all cancerous tissue).
4 months from the beginning of the induction treatment
Rate of "Down-staging" From Pre-operative Clinical Staging
Tidsramme: 4 months from the beginning of the induction treatment
This is defined as the percentage of patients who had a reduction from T3/T4 disease.
4 months from the beginning of the induction treatment
Safety of the Induction Regimen
Tidsramme: 4 months from the beginning of the induction
This describes the number of patients who experienced grade 3 and higher adverse events related to the regimen.
4 months from the beginning of the induction
Median Overall Survival (Induction Treatment and Curative Surgery)
Tidsramme: up to 5 years
This is the length of time from the start of treatment that half of the patients are still alive.
up to 5 years
Median Overall Survival (Adjuvant Therpary)
Tidsramme: up to 5 years
This is the length of time from the start of treatment that half of the patients are still alive.
up to 5 years

Samarbeidspartnere og etterforskere

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

Sponsor

NYU Langone Health

Samarbeidspartnere

Bristol-Myers Squibb
Eli Lilly and Company

Etterforskere

  • Hovedetterforsker: Theresa Ryan, MD, NYU Langone Health

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. juli 2005

Primær fullføring (Faktiske)

1. september 2011

Studiet fullført (Faktiske)

1. oktober 2015

Datoer for studieregistrering

Først innsendt

4. mars 2009

Først innsendt som oppfylte QC-kriteriene

4. mars 2009

Først lagt ut (Anslag)

6. mars 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

7. desember 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. november 2015

Sist bekreftet

1. november 2015

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 04-72 (H12637)
  • BMS #CA225112 (Annen identifikator: Bristol-Myers Squibb)

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