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Standard Therapy With or Without Surgery and Mitomycin C in Treating Patients With Advanced Limited Peritoneal Dissemination of Colon Cancer

21. januar 2012 opdateret af: Walter Reed Army Medical Center

Pilot / Phase III Randomized Trial Comparing Standard Systemic Therapy to Cytoreduction + Hyperthermic Intraperitoneal Mitomycin C + Standard Systemic Therapy in Patients With Limited Peritoneal Dissemination of Colon Adenocarcinoma

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Heating mitomycin C to several degrees above normal body temperature and infusing it into the area around the tumor may kill more tumor cells. Giving mitomycin C after surgery may kill any remaining tumor cells. It is not yet known whether standard therapy is more effective with or without surgery followed by mitomycin C.

PURPOSE: This randomized phase III trial is studying standard therapy with or without surgery and mitomycin C in treating patients with advanced limited peritoneal dissemination of colon cancer

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

Primary

  • To compare the overall survival (OS) of patients with advanced limited peritoneal dissemination of colon adenocarcinoma treated with systemic therapy with vs without cytoreduction surgery and hyperthermic intraperitoneal mitomycin C.
  • To compare the relative OS at 1 year of patients treated with these regimens.

Secondary

  • To compare the progression-free survival (PFS) of patients treated with these regimens.
  • To compare the relative PFS at 1 year of patients treated with these regimens.
  • To compare the quality of life of patients treated with these regimens.
  • To compare the toxicity burden of these regimens in these patients.
  • To compare the OS and PFS according to patients' peritoneal surface tumor genotype for the NAD(P)H (quinone oxidoreductase 1 [NQO1] 609C >T polymorphism [wild type vs heterozygous/homozygous mutant]) in patients treated with these regimens.
  • To compare circulating tumor cells in patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to presentation (synchronous vs metachronous carcinomatosis), ECOG performance status (0 vs 1), disease volume (measurable vs non-measurable), prior first-line therapy for advanced disease (chemo-naïve vs prior first-line therapy), planned chemotherapy (oxaliplatin vs irinotecan vs fluorouracil/leucovorin calcium vs capecitabine), and planned biologic therapy (bevacizumab vs cetuximab vs none). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive standard systemic therapy, at the discretion of patients' oncologist, comprising combinations of fluorouracil, leucovorin calcium, irinotecan hydrochloride, oxaliplatin, and/or capecitabine (including FOLFOX4, mFOLFOX6, CapeOx, or FOLFIRI) with or without bevacizumab (beginning 4-6 weeks after major surgery) or cetuximab*. Treatment repeats in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may crossover to arm II.

NOTE: *For patients with KRAS wild-type tumors.

  • Arm II: Patients undergo cytoreduction surgery and hyperthermic intraperitoneal mitomycin C over 45-90 minutes. Beginning 8 weeks after surgery, patients receive standard systemic therapy as in arm I. Treatment with systemic therapy repeats for 6 courses in the absence of disease progression or unacceptable toxicity.

Blood and tissue samples may be collected from patients for correlative studies.

Patients complete SF-36 Health Survey; Functional Assessment of Cancer Therapy-Colorectal (FACT-C); Feeling Sad, Down, or Depressed (CES-D); and a Brief Pain Inventory quality-of-life questionnaires at baseline and then periodically during study.

After completion of study therapy, patients are followed up periodically for 5 years.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

340

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21229
        • St. Agnes Hospital Cancer Center
    • North Carolina
      • Winston-Salem, North Carolina, Forenede Stater, 27157-1096
        • Wake Forest University Comprehensive Cancer Center

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed colon adenocarcinoma meeting the following criteria:

    • Newly diagnosed disease
    • Advanced disease
    • Confirmed synchronous or metachronous limited peritoneal disease dissemination
    • No appendiceal or rectal cancer
    • No signet ring cell type

  • Disease amenable to complete cytoreduction surgery as indicated by:

    • Peritoneal Cancer Index (PCI) ≤ 20 by helical CT scan and/or staging laparoscopy
    • No parenchymal hepatic metastases
    • No clinical (jaundice), biochemical (abnormally elevated serum bilirubin and/or alkaline phosphatase), or radiological (by ultrasound, CT scan, or MRI) biliary obstruction
    • No symptomatic malignant ascites requiring palliative paracentesis
    • Small volume of disease in the gastro-hepatic ligament defined by a < 5 cm mass in the epigastric region on cross-sectional imaging
    • No cross-sectional imaging findings indicative of multi-segmental (> 1 site) small bowel obstruction, small bowel loops matted together, or gross disease of the small bowel mesentery characterized by distortion, thickening, or loss of mesenteric vascular clarity
    • No clinical or radiological evidence of hematogenous or distant nodal (retroperitoneal, pelvic, mediastinal, peri-portal, or peri-aortic) metastasis

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • ANC > 1,200/mm³
  • WBC > 4,000/mm³
  • Platelet count 150,000/mm³

  • INR ≤ 1.5

    • Patients on therapeutic anticoagulant for unrelated medical condition such as atrial fibrillation or anti-thrombocyte treatment allowed provided treatment can be withheld for operation
  • Total serum bilirubin ≤ 1.5 mg/dL (> 1.5 mg/dL for patients with Gilbert syndrome)
  • Alkaline phosphatase < 2.5 times upper limit of normal (ULN)
  • AST < 1.5 times ULN
  • Serum creatinine normal
  • BUN normal
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

  • No history of severe congestive heart failure or severe pulmonary disease

    • Patients who are status post-revascularization procedures with satisfactory cardiac function are eligible
  • No acute myocardial infarction within the past 6 months
  • No significant history of a medical problem or co-morbidity (e.g., severe congestive heart failure or active ischemic heart disease) that would preclude a major abdominal operation
  • No concurrent second malignancy requiring systemic therapy
  • No psychiatric or addictive disorders, or other conditions that would preclude the patient from meeting the study requirements

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

  • No prior second-line systemic treatment for metastatic colon adenocarcinoma

    • Patients who received prior adjuvant therapy for colon adenocarcinoma and/or prior first-line systemic therapy for metastatic colon adenocarcinoma are eligible

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
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Arm I
Patients receive standard systemic therapy, at the discretion of patients' oncologist, comprising combinations of fluorouracil, leucovorin calcium, irinotecan hydrochloride, oxaliplatin, and/or capecitabine (including FOLFOX4, mFOLFOX6, CapeOx, or FOLFIRI), bevacizumab, or cetuximab. Treatment repeats in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may crossover to arm II.
Biologisk: bevacizumab
Givet IV
Medicin: oxaliplatin
Givet IV
Medicin: leucovorin calcium
Givet IV
Medicin: fluorouracil
Givet IV
Biologisk: cetuximab
Givet IV
Medicin: irinotecan hydrochlorid
Givet IV
Medicin: FOLFOX regime
Givet IV
Medicin: FOLFIRI regimen
Given IV
Medicin: capecitabine
Given IV
Eksperimentel: Arm II
Patients undergo cytoreduction surgery and hyperthermic intraperitoneal mitomycin C over 45-90 minutes. Beginning 8 weeks after surgery, patients receive standard systemic therapy as in arm I. Treatment with systemic therapy repeats for 6 courses in the absence of disease progression or unacceptable toxicity.
Biologisk: bevacizumab
Givet IV
Medicin: oxaliplatin
Givet IV
Medicin: leucovorin calcium
Givet IV
Medicin: fluorouracil
Givet IV
Biologisk: cetuximab
Givet IV
Medicin: irinotecan hydrochlorid
Givet IV
Medicin: FOLFOX regime
Givet IV
Medicin: FOLFIRI regimen
Given IV
Medicin: capecitabine
Given IV
Medicin: mitomycin C
Given intraperitoneally
Procedure: therapeutic conventional surgery
Patients undergo cytoreductive surgery

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Samlet overlevelse (OS)

Sekundære resultatmål

Resultatmål
Livskvalitet
Progressionsfri overlevelse (PFS)
Toxicity burden
Circulating tumor cells
Comparison of OS and PFS according to patients' peritoneal surface tumor genotype for the NAD(P)H

Samarbejdspartnere og efterforskere

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

Sponsor

Walter Reed Army Medical Center

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Alexander Stojadinovic, MD, Walter Reed Army 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. august 2010

Primær færdiggørelse (Forventet)

1. maj 2014

Datoer for studieregistrering

Først indsendt

21. juli 2010

Først indsendt, der opfyldte QC-kriterier

21. juli 2010

Først opslået (Skøn)

22. juli 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. januar 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. januar 2012

Sidst verificeret

1. januar 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CDR0000681540
  • WRAMC-8214

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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