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Using Genetic Polymorphisms to Predict the Efficacy and Toxicity - A Gastric Adenocarcinoma Study

3. mai 2016 oppdatert av: National Health Research Institutes, Taiwan

Using Genetic Polymorphisms of Drug Metabolism and Immunohistochemical Stain to Predict the Efficacy and Toxicity in Patients With Gastric Adenocarcinoma - A Phase II Study

This is an open-label, non-comparative phase II study of sequential capecitabine plus oxaliplatin followed by docetaxel plus capecitabine in patients with unresectable gastric adenocarcinoma.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

There are two primary objectives in different steps. In the first step, the primary objective of this study is to investigate the objective response rate in patients receiving sequential capecitabine plus oxaliplatin followed by docetaxel plus capecitabine in patients with unresectable gastric adenocarcinoma.

In the second step, the primary objective of this study is to screen the predictive biomarkers of three different chemotherapeutic drugs and also investigate the objective response rate in patients receiving sequential capecitabine plus oxaliplatin followed by docetaxel plus capecitabine in patients with unresectable gastric adenocarcinoma.

Studietype

Intervensjonell

Registrering (Faktiske)

51

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiesteder

  • Taiwan
    • Miaoli
      • Zhunan, Miaoli, Taiwan, 350
        • National Health Research Institutes

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

20 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Pathologically confirmed gastric adenocarcinoma.
  • At least one measurable lesion in a non-irradiated area.
  • No prior exposure to systemic chemotherapy for advanced gastric cancer.
  • For those have adjuvant chemotherapy after a curative gastrectomy, the last dosing of previous adjuvant chemotherapy should be at least 6 months before the start of this treatment.
  • Age > 20 years old.
  • ECOG Performance Status 2.
  • Life expectancy greater than 12 weeks.
  • Adequate bone marrow function :absolutely neutrophil count 1.5 x 109/L or WBC 4 x 109/L; Hemoglobin > 9 g/dl;platelet count 100 x 109/L.
  • Adequate liver function : ALT & AST 2.5 x ULN if without liver metastasis or 5 x ULN if with hepatic metastasis. Alkaline phosphatase 2.5 x ULN if without liver metastasis or 5 x ULN, if with hepatic and bone metastasis. Bilirubin < 2 x ULN
  • Adequate renal function :Creatinine < 1.5 x ULN.
  • Patients must be accessible for treatment and follow-up in the participating centers.

Exclusion Criteria:

  • Patient who are receiving concurrent radiotherapy, chemotherapy or other experimental therapy.(Previous radiotherapy is allowable if the last dose was given more than 2 weeks before the protocol treatment).
  • Major surgery within two weeks prior to entering the study.
  • Patients with CNS metastasis, including clinical suspicion.
  • Patients who are under active or uncontrolled infections.
  • Patients who had cardiac arrhythmia or myocardial infarction history 6 months before entry.
  • Patients with clinically detectable peripheral neuropathy > 2 on the CTC criteria
  • Patients with concomitant illness that might be aggravated by chemotherapy.
  • Patients who are pregnant or with breast feeding.
  • Other concomitant or previously malignancy within 5 yrs except for in situ cervix cancer or squamous cell carcinoma of the skin treated by surgery only.
  • Patients with hypersensitivity to any component of the chemotherapeutic regimen.
  • Mental status is not fit for clinical trial
  • Can not take study medication orally

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: chemotherapy

Chemotherapy:

Drug: Capecitabine, Oxaliplatin, Docetaxel Dosing Regimena: total of 6 cycles of modified XELOX regimen repeats every 2 weeks, and followed by 4 cycles of TX repeats every 3 weeks. After 10 cycles of treatment, patients may continue to treat with either of the regimen, preferably the one having the best efficacy.
Legemiddel: Capecitabine, Oxaliplatin, Docetaxel

Capecitabine: 500 mg film coated tablets; Oxaliplatin: 50 mg/ 10 ml; Docetaxel: 20 mg / 0.5ml vial.

Dosing Regimena: total of 6 cycles of modified XELOX regimen repeats every 2 weeks, and followed by 4 cycles of TX repeats every 3 weeks. After 10 cycles of treatment, patients may continue to treat with either of the regimen, preferably the one having the best efficacy.

Andre navn:
  • Capecitabine (Xeloda○R), company: Roche
  • Oxaliplatin (Eloxatin○R, company: Sanofi-Avantis
  • Docetaxel (Taxotere○R, company: Sanofi-Avantis

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Objective response rate
Tidsramme: Every 6 weeks
Tumor responses in measurable lesions are to be evaluated by the tumor response guidelines validated by the Response Evaluation Criteria in Solid Tumors (RECIST) Group . The new version 1.1 was published in 2009.
Every 6 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression-free survival
Tidsramme: Every 6 weeks
Be calculated as the duration between the first date of randomization and the date of disease recurrence or progression according to RECIST (failed), taking the status of tumor at the treatment has been completed as the reference, or death (failed), or the date of withdrawal (last contact date, censored), or the scheduled data analysis date (censored).
Every 6 weeks

Samarbeidspartnere og etterforskere

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

Sponsor

National Health Research Institutes, Taiwan

Samarbeidspartnere

Mackay Memorial Hospital
Taipei Veterans General Hospital, Taiwan
National Cheng-Kung University Hospital
Tri-Service General Hospital

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. mars 2012

Primær fullføring (Faktiske)

1. oktober 2014

Studiet fullført (Faktiske)

1. desember 2015

Datoer for studieregistrering

Først innsendt

5. mars 2012

Først innsendt som oppfylte QC-kriteriene

16. mars 2012

Først lagt ut (Anslag)

20. mars 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

4. mai 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. mai 2016

Sist bekreftet

1. oktober 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • T3211
  • 100CT202 (Annet stipend/finansieringsnummer: NRPB)

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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