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Bevacizumab Plus Fluorouracil and Leucovorin in Treating Patients With Locally Advanced or Metastatic Stage IV Colorectal Cancer That Has Progressed After Standard Chemotherapy

18. juni 2013 oppdatert av: National Cancer Institute (NCI)

A Multicenter Study of the Anti-VEGF Monoclonal Antibody Bevacizumab (Avastin®) Plus 5-Fluorouracil/Leucovorin in Patients With Metastatic Colorectal Cancers That Have Progressed After Standard Chemotherapy

RATIONALE: Bevacizumab may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy such as fluorouracil and leucovorin use different ways to stop tumor cells from dividing so they stop growing or die. Combining bevacizumab with fluorouracil and leucovorin may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining bevacizumab with fluorouracil and leucovorin in treating patients who have locally advanced or metastatic stage IV colorectal cancer that has progressed after standard chemotherapy.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

OBJECTIVES:

  • Determine the response rate of patients treated with bevacizumab, fluorouracil, and leucovorin calcium for stage IV colorectal cancer that has progressed after standard chemotherapy.
  • Determine the time to progression and overall survival of patients treated with this regimen.
  • Determine the safety of administering "bolus" and continuous infusion fluorouracil and leucovorin calcium in patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study. Patients receive 1 of 2 treatment regimens.

  • Regimen I: Patients receive bevacizumab IV on days 1, 15, 29, and 42 (every 2 weeks) and leucovorin calcium (CF) IV over 2 hours and fluorouracil (5-FU) IV bolus on days 1, 8, 15, 22, 29, and 36.
  • Regimen II: Patients receive bevacizumab as in regimen I and CF IV over 2 hours and 5-FU IV bolus followed by a continuous infusion over 22 hours on days 1, 2, 15, 16, 29, 30, 43, and 44.

For both regimens, courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed for tumor response and survival.

PROJECTED ACCRUAL: Various NCI-designated Clinical Cancer Centers and other medical institutions across the United States will participate in this study. A total of 35-125 patients will be accrued for this study within 3 months.

Studietype

Intervensjonell

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • Alaska
      • Anchorage, Alaska, Forente stater, 99519-6604
        • Providence Alaska Medical Center
    • California
      • Los Angeles, California, Forente stater, 90033-0804
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Los Angeles, California, Forente stater, 90024
        • Jonsson Comprehensive Cancer Center, UCLA
    • Colorado
      • Aurora, Colorado, Forente stater, 80010
        • University of Colorado Cancer Center at University of Colorado Health Sciences Center
    • Connecticut
      • New Haven, Connecticut, Forente stater, 06520-8028
        • Yale Comprehensive Cancer Center
    • District of Columbia
      • Washington, District of Columbia, Forente stater, 20007
        • Lombardi Cancer Center
    • Georgia
      • Atlanta, Georgia, Forente stater, 30342-1701
        • CCOP - Atlanta Regional
    • Illinois
      • Chicago, Illinois, Forente stater, 60611
        • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
      • Maywood, Illinois, Forente stater, 60153
        • Loyola University Medical Center
    • Iowa
      • Iowa City, Iowa, Forente stater, 52242-1009
        • Holden Comprehensive Cancer Center
      • Sioux City, Iowa, Forente stater, 51101-1733
        • Siouxland Hematology-Oncology
    • Kansas
      • Wichita, Kansas, Forente stater, 67214-3882
        • CCOP - Wichita
    • Maine
      • Bangor, Maine, Forente stater, 04401
        • Cancer Care of Maine
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48106
        • Saint Joseph Mercy Health System
    • Minnesota
      • Duluth, Minnesota, Forente stater, 55805
        • St. Mary's/Duluth Clinic Cancer Center
    • Mississippi
      • Jackson, Mississippi, Forente stater, 39216-4505
        • University of Mississippi Medical Center
    • Montana
      • Billings, Montana, Forente stater, 59101
        • CCOP - Montana Cancer Consortium
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89106
        • Southern Nevada Cancer Research Foundation
    • New Hampshire
      • Lebanon, New Hampshire, Forente stater, 03756-0002
        • Norris Cotton Cancer Center
    • New York
      • Buffalo, New York, Forente stater, 14263-0001
        • Roswell Park Cancer Institute
      • New York, New York, Forente stater, 10021
        • New York Weill Cornell Cancer Center at Cornell University
    • North Carolina
      • Durham, North Carolina, Forente stater, 27710
        • Duke Comprehensive Cancer Center
      • Winston-Salem, North Carolina, Forente stater, 27157-1082
        • Comprehensive Cancer Center at Wake Forest University
    • North Dakota
      • Fargo, North Dakota, Forente stater, 58122
        • Meritcare Roger Maris Cancer Center
    • Ohio
      • Cleveland, Ohio, Forente stater, 44106-5065
        • Ireland Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73104
        • University of Oklahoma Health Sciences Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • Abramson Cancer Center of the University of Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19107-5541
        • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
    • South Dakota
      • Sioux Falls, South Dakota, Forente stater, 57104
        • Sioux Valley Clinics - Oncology
    • Vermont
      • Burlington, Vermont, Forente stater, 05401
        • Fletcher Allen Health Care - University Health Center Campus
    • Virginia
      • Richmond, Virginia, Forente stater, 23298-0037
        • Massey Cancer Center
    • Washington
      • Seattle, Washington, Forente stater, 98109
        • Seattle Cancer Care Alliance
      • Seattle, Washington, Forente stater, 98101
        • CCOP - Virginia Mason Research Center

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 og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed colorectal adenocarcinoma

    • Stage IV (metastatic) disease
    • Not curable by surgery or radiotherapy

  • Must have received prior standard chemotherapy regimens, including oxaliplatin and irinotecan, and meet both of the following criteria:

    • Disease progression during or after irinotecan-based chemotherapy for metastatic disease OR relapsed disease within 6 months after adjuvant irinotecan-based therapy
    • Disease progression during or after oxaliplatin-based chemotherapy for metastatic disease OR relapsed disease within 6 months after adjuvant oxaliplatin-based therapy
  • No brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • Not specified

Hematopoietic

  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9 g/dL (transfusion allowed)
  • No evidence of bleeding diathesis or coagulopathy

Hepatic

  • Bilirubin no greater than 1.5 mg/dL
  • AST less than 5 times upper limit of normal (ULN)
  • Alkaline phosphatase less than 5 times ULN
  • PT and INR no greater than 1.5 times ULN
  • PTT no greater than ULN

Renal

  • Creatinine no greater than 1.5 times ULN
  • Proteinuria less than grade 1 OR
  • Proteinuria less than 500 mg/24 hours

Cardiovascular

  • No prior stroke
  • No uncontrolled high blood pressure
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No myocardial infarction within the past 6 months
  • No New York Heart Association class III or IV heart disease
  • No thromboembolism within the past 6 months

Other

  • Chemonaive
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 3 months after study participation
  • No significant traumatic injury within the past 6 weeks
  • No prior allergic reaction attributed to compounds of similar chemical or biological composition to bevacizumab or other study agents
  • No active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No serious nonhealing wound (including wounds healing by secondary intention), ulcer, or bone fracture

  • No CNS disease, including either of the following:

    • Primary brain tumor
    • Seizures not controlled with standard medical therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 8 weeks since prior monoclonal antibody therapy
  • No prior bevacizumab

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • Not specified

Radiotherapy

  • At least 4 weeks since prior major radiotherapy (e.g., chest or bone palliative radiotherapy)

Surgery

  • More than 6 weeks since prior major surgical procedure or open biopsy
  • More than 7 days since prior fine needle aspiration or core biopsy
  • No concurrent surgery

Other

  • Recovered from prior therapy
  • At least 3 weeks since prior cytotoxic agents

  • No concurrent therapeutic anticoagulation

    • Prophylactic anticoagulation of venous access devices allowed provided PT/INR or PTT criteria are met
  • No concurrent chronic aspirin (greater than 325 mg/day) or nonsteroidal anti-inflammatory drugs
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational or commercial agents for the malignancy

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Masking: Ingen (Open Label)

Samarbeidspartnere og etterforskere

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

Sponsor

National Cancer Institute (NCI)

Etterforskere

  • Hovedetterforsker: Helen X. Chen, MD, NCI - Investigational Drug Branch

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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. august 2003

Studiet fullført (Faktiske)

1. juli 2007

Datoer for studieregistrering

Først innsendt

6. august 2003

Først innsendt som oppfylte QC-kriteriene

6. august 2003

Først lagt ut (Anslag)

7. august 2003

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

20. juni 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. juni 2013

Sist bekreftet

1. april 2004

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CDR0000320506
  • CTEP-TRC-0301

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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