Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Combination Chemotherapy Plus Bevacizumab in Treating Patients With Advanced Colorectal Cancer

20. juni 2013 oppdatert av: Eastern Cooperative Oncology Group

Phase II Trial of Fluorouracil (5-FU), Leucovorin (LV), Irinotecan (CPT-11) and Bevacizumab (Anti-VEGF) in Previously Untreated Patients With Advanced Colorectal Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bevacizumab may stop the growth of colorectal cancer by stopping blood flow to the tumor.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus bevacizumab in treating patients who have advanced colorectal cancer.

Studieoversikt

Status

Fullført

Forhold

Tykktarmskreft

Intervensjon / Behandling

Detaljert beskrivelse

OBJECTIVES: I. Determine the progression-free survival at 7 months of patients with previously untreated advanced colorectal cancer treated with fluorouracil, leucovorin calcium, irinotecan, and bevacizumab. II. Determine the response rate and overall survival of this patient population treated with this regimen. III. Determine the toxicity of this treatment regimen in these patients.

OUTLINE: This is a multicenter study. Patients receive irinotecan IV over 90 minutes, leucovorin calcium IV, and fluorouracil IV once weekly for 4 weeks. Patients also receive bevacizumab IV over 30-90 minutes once every 2 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 1 year.

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
- Arizona
  - Scottsdale, Arizona, Forente stater, 85259-5404
    - CCOP - Scottsdale Oncology Program
- California
  - Duarte, California, Forente stater, 91010-3000
    - Cancer Center and Beckman Research Institute, City of Hope
  - Palo Alto, California, Forente stater, 94304
    - Veterans Affairs Medical Center - Palo Alto
  - Stanford, California, Forente stater, 94305-5408
    - Stanford University Medical Center
- Colorado
  - Denver, Colorado, Forente stater, 80209-5031
    - CCOP - Colorado Cancer Research Program, Inc.
- Delaware
  - Wilmington, Delaware, Forente stater, 19899
    - CCOP - Christiana Care Health Services
- District of Columbia
  - Washington, District of Columbia, Forente stater, 20307-5000
    - Walter Reed Army Medical Center
  - Washington, District of Columbia, Forente stater, 20060
    - MBCCOP-Howard University Cancer Center
- Florida
  - Gainesville, Florida, Forente stater, 32608-1197
    - Veterans Affairs Medical Center - Gainsville
  - Miami, Florida, Forente stater, 33125
    - Veterans Affairs Medical Center - Miami
  - Tampa, Florida, Forente stater, 33612-9497
    - H. Lee Moffitt Cancer Center and Research Institute
  - Tampa, Florida, Forente stater, 33612
    - Veterans Affairs Medical Center - Tampa (Haley)
- Georgia
  - Atlanta, Georgia, Forente stater, 30322
    - Emory University Hospital - Atlanta
  - Decatur, Georgia, Forente stater, 30033
    - Veterans Affairs Medical Center - Atlanta (Decatur)
- Illinois
  - Chicago, Illinois, Forente stater, 60611-3013
    - Robert H. Lurie Comprehensive Cancer Center, Northwestern University
  - Chicago, Illinois, Forente stater, 60611
    - Veterans Affairs Medical Center - Lakeside Chicago
  - Decatur, Illinois, Forente stater, 62526
    - CCOP - Central Illinois
  - Evanston, Illinois, Forente stater, 60201
    - CCOP - Evanston
  - Peoria, Illinois, Forente stater, 61602
    - CCOP - Illinois Oncology Research Association
  - Urbana, Illinois, Forente stater, 61801
    - CCOP - Carle Cancer Center
- Indiana
  - Indianapolis, Indiana, Forente stater, 46202-5289
    - Indiana University Cancer Center
  - Indianapolis, Indiana, Forente stater, 46202
    - Veterans Affairs Medical Center - Indianapolis (Roudebush)
- Iowa
  - Cedar Rapids, Iowa, Forente stater, 52403-1206
    - CCOP - Cedar Rapids Oncology Project
  - Des Moines, Iowa, Forente stater, 50309-1016
    - CCOP - Iowa Oncology Research Association
  - Iowa City, Iowa, Forente stater, 52242-1009
    - Holden Comprehensive Cancer Center at the University of Iowa
- Kansas
  - Wichita, Kansas, Forente stater, 67218
    - Veterans Affairs Medical Center - Wichita
- Louisiana
  - New Orleans, Louisiana, Forente stater, 70121
    - CCOP - Ochsner
  - New Orleans, Louisiana, Forente stater, 70112
    - MBCCOP - LSU Health Sciences Center
- Maryland
  - Baltimore, Maryland, Forente stater, 21231-2410
    - Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Massachusetts
  - Boston, Massachusetts, Forente stater, 02215
    - Beth Israel Deaconess Medical Center
  - Boston, Massachusetts, Forente stater, 02111
    - New England Medical Center Hospital
- Michigan
  - Ann Arbor, Michigan, Forente stater, 48106
    - CCOP - Ann Arbor Regional
  - Kalamazoo, Michigan, Forente stater, 49007-3731
    - CCOP - Kalamazoo
- Minnesota
  - Duluth, Minnesota, Forente stater, 55805
    - CCOP - Duluth
  - Minneapolis, Minnesota, Forente stater, 55417
    - Veterans Affairs Medical Center - Minneapolis
  - Minneapolis, Minnesota, Forente stater, 55455
    - University of Minnesota Cancer Center
  - Rochester, Minnesota, Forente stater, 55905
    - Mayo Clinic Cancer Center
  - Saint Louis Park, Minnesota, Forente stater, 55416
    - CCOP - Metro-Minnesota
- Nebraska
  - Omaha, Nebraska, Forente stater, 68131
    - CCOP - Missouri Valley Cancer Consortium
  - Omaha, Nebraska, Forente stater, 68105
    - Veterans Affairs Medical Center - Omaha
- Nevada
  - Las Vegas, Nevada, Forente stater, 89106
    - CCOP - Southern Nevada Cancer Research Foundation
- New Jersey
  - East Orange, New Jersey, Forente stater, 07018-1095
    - Veterans Affairs Medical Center - East Orange
  - Hackensack, New Jersey, Forente stater, 07601
    - CCOP - Northern New Jersey
  - New Brunswick, New Jersey, Forente stater, 08901
    - Cancer Institute Of New Jersey
- New York
  - Albany, New York, Forente stater, 12208
    - Veterans Affairs Medical Center - Albany
  - Bronx, New York, Forente stater, 10461
    - Albert Einstein Comprehensive Cancer Center
  - Bronx, New York, Forente stater, 10466
    - MBCCOP-Our Lady of Mercy Cancer Center
  - Brooklyn, New York, Forente stater, 11209
    - Veterans Affairs Medical Center - Brooklyn
  - New York, New York, Forente stater, 10016
    - NYU School of Medicine's Kaplan Comprehensive Cancer Center
  - New York, New York, Forente stater, 10010
    - Veterans Affairs Medical Center - New York
  - Rochester, New York, Forente stater, 14642
    - University of Rochester Cancer Center
- North Dakota
  - Fargo, North Dakota, Forente stater, 58122
    - CCOP - Merit Care Hospital
- Ohio
  - Cleveland, Ohio, Forente stater, 44195
    - Cleveland Clinic Taussig Cancer Center
  - Cleveland, Ohio, Forente stater, 44106-5065
    - Ireland Cancer Center
  - Cleveland, Ohio, Forente stater, 44106
    - Veterans Affairs Medical Center - Cleveland
  - Columbus, Ohio, Forente stater, 43206
    - CCOP - Columbus
  - Toledo, Ohio, Forente stater, 43623-3456
    - CCOP - Toledo Community Hospital Oncology Program
- Oklahoma
  - Tulsa, Oklahoma, Forente stater, 74136
    - CCOP - Sooner State
- Pennsylvania
  - Danville, Pennsylvania, Forente stater, 17822-2001
    - CCOP - Geisinger Clinic and Medical Center
  - Philadelphia, Pennsylvania, Forente stater, 19111
    - Fox Chase Cancer Center
  - Philadelphia, Pennsylvania, Forente stater, 19102-1192
    - Hahnemann University Hospital
  - Philadelphia, Pennsylvania, Forente stater, 19104-4283
    - University of Pennsylvania Cancer Center
  - Philadelphia, Pennsylvania, Forente stater, 19104-9104
    - University of Pennsylvania Health Systems
  - Pittsburgh, Pennsylvania, Forente stater, 15213-3489
    - University of Pittsburgh Cancer Institute
  - Pittsburgh, Pennsylvania, Forente stater, 15240
    - Veterans Affairs Medical Center - Pittsburgh
  - Wynnewood, Pennsylvania, Forente stater, 19096
    - CCOP - MainLine Health
- South Dakota
  - Sioux Falls, South Dakota, Forente stater, 57105-1080
    - CCOP - Sioux Community Cancer Consortium
- Tennessee
  - Nashville, Tennessee, Forente stater, 37232-6838
    - Vanderbilt-Ingram Cancer Center
  - Nashville, Tennessee, Forente stater, 37212
    - Veterans Affairs Medical Center - Nashville
- Wisconsin
  - Madison, Wisconsin, Forente stater, 53792-6164
    - University of Wisconsin Comprehensive Cancer Center
  - Madison, Wisconsin, Forente stater, 53705
    - Veterans Affairs Medical Center - Madison
  - Marshfield, Wisconsin, Forente stater, 54449
    - CCOP - Marshfield Medical Research and Education Foundation
  - Milwaukee, Wisconsin, Forente stater, 53226
    - Medical College of Wisconsin
  - Milwaukee, Wisconsin, Forente stater, 53295
    - Veterans Affairs Medical Center - Milwaukee (Zablocki)
Puerto Rico
- - San Juan, Puerto Rico, 00927-5800
    - MBCCOP - San Juan
  - San Juan, Puerto Rico, 00927-5800
    - Veterans Affairs Medical Center - San Juan
Sør-Afrika
- - Pretoria, Sør-Afrika, 0001
    - Pretoria Academic Hospitals

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 confirmed advanced or metastatic adenocarcinoma of the colon and rectum Surgically unresectable disease Measurable disease Disease outside the prior radiotherapy port and/or progressive disease within the previously irradiated volume

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 No hemorrhagic events within the past 6 months Hepatic: Bilirubin normal SGOT normal INR no greater than 1.5 Renal: Creatinine no greater than 1.5 times upper limit of normal Cardiovascular: No thromboembolic events within the past 6 months Pulmonary: No evidence of pneumonia Other: No known hypersensitivity to recombinant humanized murine monoclonal antibodies No evidence of significant active infection (e.g., peritonitis or wound abscess) Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent sargramostim (GM-CSF) Chemotherapy: At least 12 months since prior fluorouracil-based adjuvant chemotherapy No prior adjuvant irinotecan Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 2 weeks since prior radiotherapy and recovered Surgery: See Disease Characteristics Other: No prior therapy for advanced disease No concurrent therapeutic anticoagulation except for low-dose coumadin for maintenance of indwelling catheters

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Behandling

Samarbeidspartnere og etterforskere

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

Sponsor

Eastern Cooperative Oncology Group

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

Studiestol: Bruce J. Giantonio, MD, Presbyterian Medical Center

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

Gray R, Giantonio BJ, O'Dwyer PJ, et al.: The safety of adding angiogenesis inhibition into treatment for colorectal, breast, and lung cancer: the Eastern Cooperative Oncology Group's (ECOG) experience with bevacizumab (anti-VEGF). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-825, 2003.
Giantonio BJ, Chen HX, Catalano PJ, et al.: Bowel perforation and fistula formation in colorectal cancer patients treated on Eastern Cooperative Oncology Group (ECOG) studies E2200 and E3200. [Abstract] J Clin Oncol 22 (Suppl 14): A-3017, 199s, 2004.
Giantonio BJ, Levy DE, O'dwyer PJ, Meropol NJ, Catalano PJ, Benson AB 3rd; Eastern Cooperative Oncology Group. A phase II study of high-dose bevacizumab in combination with irinotecan, 5-fluorouracil, leucovorin, as initial therapy for advanced colorectal cancer: results from the Eastern Cooperative Oncology Group study E2200. Ann Oncol. 2006 Sep;17(9):1399-403. doi: 10.1093/annonc/mdl161. Epub 2006 Jul 27.
Giantonio BJ, Levy D, O'Dwyer PJ, et al.: Bevacizumab (anti-VEGF) plus IFL (irinotecan, fluorouracil, leucovorin) as front-line therapy for advanced colorectal cancer (advCRC): results from the Eastern Cooperative Oncology Group (ECOG) Study E2200. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1024, 2003.
Giantonio BJ, Levy D, Catalano PJ, et al.: Incorporating angiogenesis inhibition with bevacizumab (anti-VEGF) into frontline chemotherapy with irinotecan (CPT-11), fluorouracil and leucovorin (FU/LV) for advanced colorectal cancer (advCRC): a toxicity analysis of ECOG study E2200. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-503, 2002.

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. november 2000

Studiet fullført (Faktiske)

1. september 2006

Datoer for studieregistrering

Først innsendt

6. desember 2000

Først innsendt som oppfylte QC-kriteriene

11. februar 2004

Først lagt ut (Anslag)

12. februar 2004

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

24. juni 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. juni 2013

Sist bekreftet

1. september 2006

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

CDR0000068328
ECOG-E2200

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. .