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Efficacy and Safety of Palonosetron Hydrochloride in the Prevention of Nausea and Vomiting (ESPNV)

28. desember 2012 oppdatert av: Zhan Wang, Shanghai Changzheng Hospital

A Multi-center, Stratified Randomized, Controlled Study to Evaluate the Efficacy and Safety of Palonosetron Hydrochloride in the Prevention of Nausea and Vomiting Associated With Moderate and Highly Emetogenic Chemotherapy in China

This purpose of this study is to evaluate the efficacy and safety of single and repeated doses of palonosetron hydrochloride in preventing nausea and vomiting caused by moderate and highly emetogenic chemotherapy in patients.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Group I (Highly Emetogenic Chemotherapy): Patients that accepted chemotherapy including Cisplatin≥50mg/m2, Carmustine>250mg/m2, Cyclophosphamide>1500mg/m2, Dacarbazine>60mg/m2, Doxorubicin>60mg/m2, Epirubicin>90mg/m2, IFO≥10g/m2 or AC program.

Group II (Moderately Emetogenic Chemotherapy): Patients that accepted chemotherapy including any dose of Carboplatin, Daunorubicin, Oaliplatin, Irinotecan, or Doxorubicin<60mg/m2(not include liposomal doxorubicin), Epirubicin≤90mg/m2, Carmustine≤250mg/m2, Methotrexate≥250mg/m2, Cyclophosphamide≤1500mg/m2, Arabinoside>200mg/m2, IFO<10g/m2, Cisplatin≥50mg/m2.

Total subjects: 1000, single dose of palonosetron group of 500 patients, repeated doses of palonosetron group of 500 patients. According to the study subjects receiving highly emetogenic chemotherapy or moderately emetogenic chemotherapy, subjects are stratified randomize.

Studietype

Intervensjonell

Registrering (Faktiske)

599

Fase

  • Fase 4

Kontakter og plasseringer

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

Studiesteder

  • Kina
    • Anhui
      • Hefei, Anhui, Kina
        • Anhui Provincial Hospital
    • Beijing
      • Beijing, Beijing, Kina
        • Chinese Academy of Medical Sciences Cancer Hospital
      • Beijing, Beijing, Kina
        • Chinese PLA 301 Hospital
      • Beijing, Beijing, Kina
        • Chinese PLA 307 Hospital
      • Beijing, Beijing, Kina
        • Chinese PLA Navy General Hospital
    • Fujian
      • Fuzhou, Fujian, Kina
        • Fuzhou General hospital of Nanjing Military Command
    • Guangxi
      • Nanning, Guangxi, Kina
        • Guangxi Cancer Hospital
    • Hunan
      • Changsha, Hunan, Kina
        • The Second Xiangya Hospital of Central South University
    • Jiangsu
      • Changzhou, Jiangsu, Kina
        • The First People's Hospital of Changzhou
      • Nanjing, Jiangsu, Kina
        • Nanjing General Hospital of Nanjing Military Command
      • Suzhou, Jiangsu, Kina
        • The First Affiliated Hospital of Soochow University
      • Wuxi, Jiangsu, Kina
        • The Fourth People's Hospital of Wuxi
    • Shandong
      • Jinan, Shandong, Kina
        • Shandong Provincial Hospital
      • Jinan, Shandong, Kina
        • Shandong Cancer Hospital
      • Qingdao, Shandong, Kina
        • The Affiliated Hospital of Medical College Qingdao University
    • Shanghai
      • Shanghai, Shanghai, Kina
        • Shanghai Changzheng Hospital
      • Shanghai, Shanghai, Kina
        • Shanghai Xinhua hospital
    • Shanxi
      • Xian, Shanxi, Kina
        • Tangdu Hospital of Fourth Military Medical University

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 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Patients candidates to a chemotherapy treatment, with histologically or cytologically confirmed malignant disease;
  2. The concrete chemotherapy plan does not limited, group I (Highly Emetogenic Chemotherapy), group II (Moderately Emetogenic Chemotherapy);
  3. Male or female aged 18-75 years, ECOG≤2, estimates survival time≥3 months;
  4. WBC≥3.0×109/L, ANC≥1.5×109/L, PLT≥80×109/L, total bilirubin≤1.5×ULN(Normal value upper limit), AST and ALT≤2.5×ULN(With transferability liver cancer≤5×ULN), Cr and BUN≤1.5×ULN, electrolyte and electrocardiogram are normal, conforms to the chemotherapy adaptation;
  5. Patients have been apart from the previous chemotherapy to finish above 2 weeks (including 2 weeks);
  6. Patients that voluntarily sign the consent form.

Exclusion Criteria:

  1. Pregnancy, or patients during breast feeding;
  2. Patients have accepted any radiotherapy during the experimental period;
  3. Gastric outlet or intestinal obstruction;
  4. Patients have serious heart diseases, liver kidney diseases, or metabolism function disorder;
  5. Patients have epilepsy, or have been used psychotropic drug and calm drug;
  6. Received any drugs with potential anti-emetic efficacy, or experienced any vomiting, nausea or retching in the 24 hours prior to chemotherapy;
  7. Patients with transferability brain tumor, have vomiting caused by skull high pressure, or can not speak sickness situation and adverse reactions by self;
  8. Patients have known hypersensitivity to 5-HT3 antagonists;
  9. Patients have chemotherapy contraindications;
  10. Patients are participating, or have participated in other Clinical studies of new drugs within 2 weeks.

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: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: H PALO day 1
Highly Emetogenic Arm, Palonosetron 0.25mg IV*1 dose on day 1
Legemiddel: Palonosetron Hydrochloride
0.25 mg IV*1 dose on day 1, 30 minutes prior to the administration of the major chemotherapeutic agent.
Legemiddel: Palonosetron Hydrochloride
0.25mg IV*3 doses on days 1,3 and 5,30 minutes prior to the administration of the major chemotherapeutic agent.
Eksperimentell: H PALO day 1,3,5
Highly Emetogenic Arm, Palonosetron 0.25mg IV*3 doses on days 1,3 and 5
Legemiddel: Palonosetron Hydrochloride
0.25 mg IV*1 dose on day 1, 30 minutes prior to the administration of the major chemotherapeutic agent.
Legemiddel: Palonosetron Hydrochloride
0.25mg IV*3 doses on days 1,3 and 5,30 minutes prior to the administration of the major chemotherapeutic agent.
Aktiv komparator: M PALO day 1
Moderately Emetogenic Arm, Palonosetron 0.25mg IV*1 dose on day 1
Legemiddel: Palonosetron Hydrochloride
0.25 mg IV*1 dose on day 1, 30 minutes prior to the administration of the major chemotherapeutic agent.
Legemiddel: Palonosetron Hydrochloride
0.25mg IV*3 doses on days 1,3 and 5,30 minutes prior to the administration of the major chemotherapeutic agent.
Eksperimentell: M PALO day 1,3,5
Moderately Emetogenic Arm, Palonosetron 0.25mg IV*3 doses on days 1,3 and 5
Legemiddel: Palonosetron Hydrochloride
0.25 mg IV*1 dose on day 1, 30 minutes prior to the administration of the major chemotherapeutic agent.
Legemiddel: Palonosetron Hydrochloride
0.25mg IV*3 doses on days 1,3 and 5,30 minutes prior to the administration of the major chemotherapeutic agent.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Complete Response rate
Tidsramme: 2-7 days
defined as no emetic episode and no use of rescue medication
2-7 days

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Complete Response rate
Tidsramme: 0-24 hours, 0-7 days
defined as no emetic episode and no use of rescue medication
0-24 hours, 0-7 days

Samarbeidspartnere og etterforskere

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

Sponsor

Shanghai Changzheng Hospital

Samarbeidspartnere

JiangSu Chia-Tai Tianqin Pharmacy Co.Ltd

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 2011

Primær fullføring (Faktiske)

1. august 2012

Datoer for studieregistrering

Først innsendt

28. oktober 2011

Først innsendt som oppfylte QC-kriteriene

27. november 2011

Først lagt ut (Anslag)

30. november 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

31. desember 2012

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. desember 2012

Sist bekreftet

1. desember 2012

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • zhiruo

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