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Hepatic Arterial Infusion With FOLFOX Alone or in Combination With IV Chemotherapy in Colon Cancer With Liver Metastasis

22. august 2017 opdateret af: Jordan Waypa, Western Regional Medical Center

Phase 2 Study of Hepatic Arterial Infusion With Oxaliplatin, Folinic Acid and 5 Fluorouracil Alone or in Combination With Intravenous Chemotherapy in Heavily Pre-Treated Patients With Liver-Predominant Metastasis From Colorectal Cancer

In this study, Hepatic Arterial Infusion will be combined with systemic therapy for patients with liver-only or liver-predominant metastases who have failed at least one line of systemic chemotherapy.

Studieoversigt

Detaljeret beskrivelse

In this phase II study, investigators will combine the HAI with systemic therapy for patients with liver-only or liver-predominant metastases who have failed at least one line of systemic chemotherapy. We hypothesize that combination therapy will be able to convert some patients to surgical resection candidates, or/and to overcome chemo-resistance of liver metastases to systemic i.v. chemotherapy for some clinically fit, heavily pre-treated patients

Undersøgelsestype

Interventionel

Fase

  • Fase 2

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Performance status ECOG 0-2 and a life expectancy of >3 months.
  2. Patients were required to have measurable disease in the liver, defined as lesions measuring >1 cm in largest diameter on spiral-computed tomography (CT) or magnetic resonance imaging (MRI)
  3. Histologically confirmed metastatic advanced solid tumors involving the liver, liver replacement less than 70%
  4. No bevacizumab (avastin) use within 4 weeks prior to enrollment.
  5. Absence of portal vein thrombosis
  6. Not a surgical candidate or patients refuse surgery
  7. Loss of response to at least two lines of systemic chemotherapy including FU, Oxaliplatin or irinotecan in metastatic setting
  8. An asymptomatic extra-hepatic disease is allowed, provided that the extent of the metastatic disease in the liver represented the bulk of the metastatic disease.
  9. History of liver-directed therapy is eligible at the investigator's discretion.
  10. Adequate renal function with a calculated creatinine clearance greater than 60 mL/min.
  11. Hepatic function as follows: Total Bilirubin ≤3 mg/dL, AST ≤5 times upper normal reference value, or ALT ≤ 5 times upper normal reference value.
  12. Adequate bone marrow function (ANC ≥1500 cells/uL; PLT ≥ 100,000 cells/uL) before each therapy.
  13. At least three weeks from previous immunotherapy, chemotherapy or radiotherapy before being enrolled in this study.
  14. All females in childbearing age MUST have a negative serum HCG test unless patients have prior hysterectomy. Women of childbearing potential must take adequate precautions to prevent pregnancy during treatment.
  15. Patient consent must be obtained prior to entrance onto study

Exclusion Criteria:

  1. Clinical or radiographic evidence of moderate amount of ascites.
  2. History of cirrhosis with Child-Pugh class B or C.
  3. Pregnant or lactating females.
  4. Inability to complete informed consent process and adhere to protocol treatment plan and follow-up requirements.
  5. Patients receiving any other investigational agents.
  6. Patients with bleeding diathesis (clinical bleeding, prothrombin time =/> 1.5 X upper institutional normal value, INR =/> 1.5, activated partial thromboplastin time aPTT =/> 1.5 X upper institutional normal value), active gastric or duodenal ulcer.
  7. History of thrombophilia, recurrent DVTs, diagnosis of phospholipid syndrome.
  8. Past or current history of malignancy other than colon cancer with the exception of treated non-melanoma skin cancer or carcinoma in situ of the cervix, or other cancers cured by local therapy alone and a DFS ≥5 years.
  9. Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements.
  10. Patients with clinically significant cardiovascular disease: myocardial infarction or unstable angina within 6 months, New York Heart Association Grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, unstable angina pectoris, clinically significant peripheral vascular disease
  11. Patients have untreated brain metastasis or leptomeningeal metastases requiring immediate intervention.

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: Hepatic Artery Infusion
Hepatic Arterial Infusion (HAI) with the drugs Oxaliplatin, Folinic Acid and 5 Fluorouracil
infusion over 12 hours via HAI
Andre navne:
  • Eloxatin®
as a 2-hour infusion via HAI on day 2
Andre navne:
  • Leucovorin
Following Folinic Acid as a continuous infusion over 48 hours on days 2, 3
Andre navne:
  • 5-FU

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Determine response rate
Tidsramme: one year
one year

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Jiaxin Niu, MD, Western Regional Medical Center

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. december 2012

Primær færdiggørelse (Forventet)

1. december 2013

Studieafslutning (Forventet)

1. december 2013

Datoer for studieregistrering

Først indsendt

12. juni 2013

Først indsendt, der opfyldte QC-kriterier

19. januar 2015

Først opslået (Skøn)

26. januar 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. august 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. august 2017

Sidst verificeret

1. august 2017

Mere information

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 .

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