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Trial of Panitumumab Cisplatin, Fluourouracil and Docetaxel in Locally Advanced or Metastatic Gastric Cancer

7. oktober 2015 opdateret af: Hellenic Oncology Research Group

Phase I/II, Multicenter, Single-Arm Clinical Trial of Panitumumab in Combination With Cisplatin, Fluourouracil and Docetaxel (DCF) in Locally Advanced or Metastatic Cancer of the Stomach and Gastro-oesophageal Junction.

Investigators propose to study the effect of panitumumab when combined with an active regimen, such as DCF (Docetaxel/Cisplatin/Fluourouracil), in previously untreated patients with advanced cancer of the stomach.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Investigators propose a phase I/II study in order to evaluate the effect of panitumumab when combined with an active regimen, such as DCF (Docetaxel/Cisplatin/Fluourouracil), in chemotherapy - naive patients with advanced cancer of the stomach.

Investigators hypothesize that the addition of panitumumab to DCF regimen in advanced cancer of the stomach and gastroesophageal junction is feasible, well tolerated and could achieve an objective response rate of greater than 40%.

The 2-weekly schedule of DCF will be used as chemotherapy since a recently presented trial demonstrated a comparable efficacy but a more favourable toxicity profile comparable to the 3-weekly schedule.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

51

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Grækenland
      • Athens, Grækenland
        • 401 Military Hospital of Athens
      • Athens, Grækenland
        • Air Forces Military Hospital of Athens
      • Athens, Grækenland
        • "IASO" General Hospital of Athens
      • Chania, Grækenland
        • "Ag.Georgios" General Hospital of Chania
      • Heraklion, Grækenland
        • University Hospital of Crete, Dep of Medical Oncology Heraklion, Greece
      • Larissa, Grækenland
        • State General Hospital of Larissa
      • Piraeus, Grækenland
        • "Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
      • Thessaloniki, Grækenland
        • "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
      • Thessaloniki, Grækenland
        • Diabalkaniko General Hospital of Thessaloniki

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Histologically proven inoperable locally advanced or metastatic adenocarcinoma of the stomach (including adenocarcinoma of the gastrooesophageal junction)
  • Patient's age between 20 and 70 years old
  • Measurable disease defined by RECIST criteria
  • Patients with non-measurable disease could be enrolled in the phase I part of the study
  • ECOG performance status ≤ 1
  • Hgb ≥ 8g/dL, WBC ≥ 3 x 109/L , neutrophils count ≥ 1.5 x 109/L , platelets ≥100 x 109/L, Creatinine clearance ≥50 mL/min, Total bilirubin ≤ 1.5 X UNL, AST, ALT and ALP ≤ 2.5 x UNL
  • No prior chemotherapy or more than 6 months from adjuvant chemotherapy or chemo-radiation
  • Estimated life expectancy more than 3 months
  • Written informed consent

Exclusion Criteria:

  • Gastrointestinal bleeding
  • Clinically relevant, symptomatic excessive amounts of ascites resulting in patient's discomfort
  • CNS metastases
  • History of hypersensitivity to fluoropyrimidines, docetaxel or platinum compounds
  • Any previous chemotherapy or radiotherapy for advanced disease
  • Patient pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment
  • Patient (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment
  • Known hypersensitivity reaction to the component of the treatment
  • Active infection or malnutrition or bowel obstruction
  • Legal incapacity or limited legal capacity
  • Definite contraindications for the use of corticosteroids
  • History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan
  • Chronic inflammation of the bowel
  • Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment
  • Medical or psychological condition which in the opinion of the investigator would not permit the subject to complete the study or sign meaningful informed consent
  • A second primary tumor other than non-melanoma skin cancer or in situ cervical cancer

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
Panitumumab plus DCF
Medicin: Pazopanib
Andre navne:
  • Pazopanib: 800 mg én gang dagligt i op til 2 år fra datoen for første dosis

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective response rate
Tidsramme: Every 8 weeks
Patients will be followed for disease evaluation every eight (8) weeks from the first day of chemotherapy until the first documentation of disease progression
Every 8 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression Free Survival
Tidsramme: 1 year
Patients will be evaluated from the date of the first chemotherapy cycle until the date of first documented progression or date of death from any cause, whichever came first
1 year
Overall Survival
Tidsramme: 1 year
Patients will be evaluated for overall survival from the date of the first chemotherapy cycle until the date of death from any cause
1 year
Maximum Tolerated Dose of the combination
Tidsramme: Up to 4 weeks
Patients will be evaluated for toxicity profil on Day 1 of the first two chemotherapy cycle (cycle repeated every 2 weeks)
Up to 4 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hellenic Oncology Research Group

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2011

Primær færdiggørelse (Faktiske)

1. januar 2015

Studieafslutning (Faktiske)

1. januar 2015

Datoer for studieregistrering

Først indsendt

2. oktober 2012

Først indsendt, der opfyldte QC-kriterier

25. oktober 2012

Først opslået (Skøn)

30. oktober 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

8. oktober 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. oktober 2015

Sidst verificeret

1. oktober 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CT/09.10

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Mavekræft

Kliniske forsøg med Pazopanib

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Sweden

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner