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Combination Chemotherapy in Treating Patients With Liver Metastases From Colorectal Cancer

12. juli 2016 opdateret af: Alliance for Clinical Trials in Oncology

PHASE III STUDY OF HEPATIC ARTERY FLOXURIDINE (FUDR), LEUCOVORIN (LV), AND DEXAMETHASONE (DEX) VERSUS SYSTEMIC 5-FLUOROURACIL (5-FU) AND LEUCOVORIN (LV) AS TREATMENT FOR HEPATIC METASTASES FROM COLORECTAL CANCER

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which chemotherapy regimen is more effective for metastatic colorectal cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of intrahepatic floxuridine, leucovorin, and dexamethasone with that of systemic fluorouracil and leucovorin in treating patients who have unresectable liver metastases from colorectal cancer.

Studieoversigt

Detaljeret beskrivelse

OBJECTIVES:

  • Compare the efficacy, toxicity, and cost of hepatic artery infusion of floxuridine, leucovorin calcium (CF), and dexamethasone vs IV fluorouracil and IV CF after resection of primary disease in patients with hepatic metastases secondary to colorectal cancer.
  • Compare the quality of life of patients treated with these regimens.
  • Measure the level of thymidylate synthase present in liver metastases, and correlate these levels with objective response and survival in patients treated with these regimens.
  • Assess the p53 mutations, and correlate findings with objective response and survival in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, percentage of liver involvement on CT scan or MRI (less than 30% vs 30% to under 70%), prior chemotherapy (none vs adjuvant chemotherapy comprising fluorouracil (5-FU) and leucovorin calcium (CF) or 5-FU, CF, and levamisole (LEV) completed at least 1 year before study vs adjuvant chemotherapy comprising 5-FU with or without LEV completed at least 6 months before study), and synchronous disease (yes vs no). Patients are randomized to 1 of 2 treatment arms.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

135

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

    • New South Wales
      • Westmead, New South Wales, Australien, 2145
        • Westmead Hospital
    • Iowa
      • Cedar Rapids, Iowa, Forenede Stater, 52403-1206
        • CCOP - Cedar Rapids Oncology Project
      • Des Moines, Iowa, Forenede Stater, 50309
        • John Stoddard Cancer Center at Iowa Methodist Medical Center
      • Des Moines, Iowa, Forenede Stater, 50309-1016
        • CCOP - Iowa Oncology Research Association
      • Des Moines, Iowa, Forenede Stater, 50316-2301
        • Iowa Lutheran Hospital
      • Des Moines, Iowa, Forenede Stater, 50314
        • Mercy Cancer Center at Mercy Medical Center-Des Moines
    • Nebraska
      • Papillion, Nebraska, Forenede Stater, 68128-4157
        • Midlands Cancer Center at Midlands Community Hospital
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87131
        • MBCCOP - University of New Mexico HSC
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44109
        • MetroHealth Medical Center
    • Pennsylvania
      • Hershey, Pennsylvania, Forenede Stater, 17033-0850
        • Penn State Cancer Institute at Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, Forenede Stater, 19111-2497
        • Fox Chase Cancer Center
    • Wisconsin
      • Green Bay, Wisconsin, Forenede Stater, 54307-3453
        • CCOP - St. Vincent Hospital Cancer Center, Green Bay
      • Lima, Peru, 34
        • Instituto De Enfermedades Neoplasicas
      • San Juan, Puerto Rico, 00936-7344
        • San Juan City Hospital

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

16 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Unresectable liver metastases secondary to colorectal cancer

    • Less than 70% liver involvement on CT scan or MRI
    • Liver biopsy required before study unless 1 of the following conditions are met:

      • Carcinoembryonic antigen greater than 30
      • 5 or more liver metastases visible on CT scan or MRI
      • Greater than 50% to under 70% liver involvement on CT scan or MRI
  • Histologically proven primary colorectal cancer that is resected or appears resectable on CT scan and physical exam

    • Documentation of previously resected primaries must be based on pathologic results of the resected tumor
    • Histological documentation of synchronous disease must be based on 1 of the following:

      • Biopsy of primary colorectal tumor before study
      • Suspicious lesion on barium enema, colonoscopy, or sigmoidoscopy, and a liver biopsy positive for adenocarcinoma consistent with the primary colorectal tumor
  • Measurable disease

    • Clearly defined liver mass measuring at least 2 cm or at least 3 liver masses on CT scan or MRI
  • No evidence of extrahepatic disease on CT scan and physical exam
  • No portal vein occlusion or ascites

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Hepatic:

  • Bilirubin no greater than 2 times normal

Other:

  • No other malignancy within the past 5 years except inactive nonmelanomatous skin cancer, carcinoma in situ of the cervix, or grade 1 bladder cancer
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

Chemotherapy:

  • At least 1 year since prior adjuvant chemotherapy comprising fluorouracil (5-FU) and leucovorin calcium (CF) or 5-FU, CF, and levamisole (LEV)
  • At least 6 months since prior adjuvant chemotherapy comprising 5-FU with or without LEV
  • No other prior chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent hormonal therapy except for nondisease-related conditions, e.g.:

    • Steroids for adrenal failure
    • Insulin for diabetes
    • Intermittent dexamethasone as an antiemetic

Radiotherapy:

  • No prior radiotherapy to the liver

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm I - laparotomy + conventional surgery + chemotherapy

Patients undergo laparotomy for placement of a hepatic artery catheter and then subcutaneous placement of a hepatic artery infusion pump. Patients with unresected primary disease also undergo resection at the time of catheter and pump placement. Beginning within 1-2 weeks after surgery, patients receive floxuridine, dexamethasone, and leucovorin calcium (CF) via continuous hepatic artery infusion on days 1-14. Treatment for patients continues every 4 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life and medical resource utilization are assessed at baseline, every 3 months for 1 year, and then at 18 months.

Patients are followed every 3 months.

Eksperimentel: Arm II - conventional surgery + chemotherapy

Patients receive CF IV and fluorouracil IV on days 1-5. Patients with unresected primary disease undergo resection within 3-4 weeks before initiation of chemotherapy.

Treatment for patients continues every 4 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life and medical resource utilization are assessed at baseline, every 3 months for 1 year, and then at 18 months.

Patients are followed every 3 months.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Samlet overlevelse
Tidsramme: Op til 5 år
Op til 5 år
Tid til progression
Tidsramme: Op til 5 år
Op til 5 år

Samarbejdspartnere og efterforskere

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

Samarbejdspartnere

Efterforskere

  • Studiestol: Nancy E. Kemeny, MD, Memorial Sloan Kettering Cancer Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

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. januar 1996

Primær færdiggørelse (Faktiske)

1. marts 2006

Studieafslutning (Faktiske)

1. august 2006

Datoer for studieregistrering

Først indsendt

1. november 1999

Først indsendt, der opfyldte QC-kriterier

26. januar 2003

Først opslået (Skøn)

27. januar 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

13. juli 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juli 2016

Sidst verificeret

1. juli 2016

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 .

Kliniske forsøg med Kolorektal cancer

Kliniske forsøg med fluorouracil

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