Patients With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy

Last updated: May 28, 2015
Sponsor: Bayer
Overall Status: Completed

Phase

3

Condition

Metastatic Cancer

Colorectal Cancer

Treatment

N/A

Clinical Study ID

NCT01103323
14387
2009-012787-14
  • Ages > 18
  • All Genders

Study Summary

This is a randomized, double-blind, placebo-controlled multi-center phase III study to evaluate efficacy and safety of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed on/after all approved drugs for CRC

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histological or cytological documentation of adenocarcinoma of the colon or rectum

  • Progression during or within 3 months following the last administration of approvedstandard therapies. Patients treated with oxaliplatin in an adjuvant setting shouldhave progressed during or within 6 months of completion of adjuvant therapy

  • Patients with measurable or non measurable disease

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of </= 1

  • Life expectancy of at least 3 months

  • Adequate bone marrow, liver and renal function

Exclusion

Exclusion Criteria:

  • Unstable/uncontrolled cardiac disease

  • History of arterial or venous thrombotic or embolic events

  • Symptomatic metastatic brain or meningeal tumors

  • Patients with evidence or history of bleeding diathesis

  • Interstitial lung disease - Persistent proteinuria >/= grade 3

  • Unresolved toxicity > grade 1 attributed to any prior therapy/procedure excludingalopecia and oxaliplatin induced neurotoxicity </= Grade 2

Study Design

Total Participants: 760
Study Start date:
April 01, 2010
Estimated Completion Date:
January 31, 2014

Study Description

All participants received Best Supportive Care. Acronyms used in Adverse events section: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE), International Normalized Ratio (INR), Central nervous system (CNS), Acute respiratory distress syndrome (ARDS), Cranial nerves (CN), Disseminated Intravascular Coagulation (DIC), Cardiac troponin T (cTnT).

Abbreviation used in Results section: Data Monitoring Committee (DMC). Adverse event collection will be covered in Adverse events section.

Connect with a study center

  • Buenos Aires, Ciudad Auton. de Buenos Aires C1122AAL
    Argentina

    Site Not Available

  • Rosario, Santa Fe S2000PBJ
    Argentina

    Site Not Available

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    San Miguel de Tucumán, Tucuman T4000GTB
    Argentina

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  • San Miguel de Tucumán, Tucuman T4000GTB
    Argentina

    Site Not Available

  • Capital Federal-Buenos Aires, C1426ANZ
    Argentina

    Site Not Available

  • Concord, New South Wales 2139
    Australia

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  • St Leonards, New South Wales 2065
    Australia

    Site Not Available

  • Woolloogabba, Queensland 4102
    Australia

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  • Woodville South, South Australia 5011
    Australia

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  • Footscray, Victoria 3011
    Australia

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  • Parkville, Victoria 3050
    Australia

    Site Not Available

  • Bruxelles - Brussel, 1200
    Belgium

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  • Edegem, 2650
    Belgium

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  • Leuven, 3000
    Belgium

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  • Roeselare, 8800
    Belgium

    Site Not Available

  • Salvador, Bahia 41830-492
    Brazil

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  • Fortaleza, Ceará 60160-230
    Brazil

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  • Belo Horizonte, Minas Gerais 30110-090
    Brazil

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    Ijuí, Rio Grande do Sul 98700-000
    Brazil

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  • Ijuí, Rio Grande do Sul 98700-000
    Brazil

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  • Vancouver, British Columbia V5Z 4E6
    Canada

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  • Winnipeg, Manitoba R2H 2A6
    Canada

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  • Moncton, New Brunswick E1C 6Z8
    Canada

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  • London, Ontario N6A 4L6
    Canada

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  • Mississauga, Ontario L5M 2N1
    Canada

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  • Oshawa, Ontario L1G 2B9
    Canada

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  • Toronto, Ontario M4N 3M5
    Canada

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  • Montreal, Quebec H3T 1E2
    Canada

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  • Quebec, G1R 2J6
    Canada

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  • Guangzhou, Guangdong 510060
    China

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  • Nanjing, Jiangsu 210009
    China

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  • Qingdao, Shandong 266100
    China

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  • Beijing, 100021
    China

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  • Changchun, 130021
    China

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  • Chongqing, 400038
    China

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  • Fuzhou, 350025
    China

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  • Ha'erbin, 150040
    China

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  • Hanghzou, 310009
    China

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  • Shanghai, 200001
    China

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  • Tianjin, 300060
    China

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  • Brno, 65 653
    Czech Republic

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  • Hradec Kralove, 500 05
    Czech Republic

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  • Olomouc, 775 20
    Czech Republic

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  • Praha, 18081
    Czech Republic

    Site Not Available

  • Avignon, 84000
    France

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  • Le Mans Cedex 2, 72015
    France

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  • Lille Cedex, 59020
    France

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  • Marseille, 13005
    France

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  • Montpellier, 34298
    France

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  • Paris, 75651
    France

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  • Reims, 51092
    France

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  • Rennes, 35042
    France

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  • Strasbourg Cedex, 67085
    France

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  • Freiburg, Baden-Württemberg 79106
    Germany

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  • Karlsruhe, Baden-Württemberg 76137
    Germany

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  • Mannheim, Baden-Württemberg 68167
    Germany

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  • Stuttgart, Baden-Württemberg 70199
    Germany

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    München, Bayern 81377
    Germany

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  • München, Bayern 81925
    Germany

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  • Hannover, Niedersachsen 30625
    Germany

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  • Oldenburg, Niedersachsen 26133
    Germany

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  • Essen, Nordrhein-Westfalen 45122
    Germany

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    Köln, Nordrhein-Westfalen 50931
    Germany

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  • Köln, Nordrhein-Westfalen 50924
    Germany

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  • Leverkusen, Nordrhein-Westfalen 51375
    Germany

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  • Porta Westfalica, Nordrhein-Westfalen 32457
    Germany

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  • Trier, Rheinland-Pfalz 54290
    Germany

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  • Dresden, Sachsen 01307
    Germany

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  • Halle, Sachsen-Anhalt 06120
    Germany

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  • Magdeburg, Sachsen-Anhalt 39104
    Germany

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  • Berlin, 13125
    Germany

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  • Budapest, 1082
    Hungary

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  • Debrecen, 4032
    Hungary

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  • Nyiregyhaza, 4400
    Hungary

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  • Szeged, 6725
    Hungary

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  • Ashkelon, 7830604
    Israel

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  • Beer Sheva, 8410101
    Israel

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  • Haifa, 3109601
    Israel

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  • Holon,
    Israel

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  • Jerusalem, 9112001
    Israel

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  • Petach Tikva, 4941492
    Israel

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  • Rehovot, 7610001
    Israel

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  • Tel Aviv, 6423906
    Israel

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  • Tel Hashomer, 5262000
    Israel

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  • Zrifin, 6093000
    Israel

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  • Brescia, 25124
    Italy

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  • Genova, 16132
    Italy

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  • Milano, 20162
    Italy

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  • Modena, 41124
    Italy

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  • Napoli, 80131
    Italy

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  • Pisa, 56126
    Italy

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  • Reggio Emilia, 42100
    Italy

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  • Roma, 00168
    Italy

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  • Nagoya, Aichi 464-8681
    Japan

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  • Kashiwa, Chiba 277-8577
    Japan

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  • Matsuyama, Ehime 791-0280
    Japan

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  • Sapporo, Hokkaido 060-8648
    Japan

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  • Osakasayama, Osaka 589-8511
    Japan

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  • Takatsuki, Osaka 569-8686
    Japan

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  • Hidaka, Saitama 350-1298
    Japan

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  • Kita-Adachigun, Saitama 362-0806
    Japan

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  • Sunto, Shizuoka 411-8777
    Japan

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  • Shimotsuke, Tochigi 329-0498
    Japan

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  • Utsunomiya, Tochigi 320-0834
    Japan

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  • Bunkyo-ku, Tokyo 113-8519
    Japan

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  • Chuo-ku, Tokyo 104-0045
    Japan

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  • Koto-ku, Tokyo 135-8550
    Japan

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  • Mitaka, Tokyo 181-8611
    Japan

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  • Chiba, 260-8717
    Japan

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  • Fukuoka, 812-8582
    Japan

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  • Kochi, 781-8555
    Japan

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  • Kumamoto, 860-8556
    Japan

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  • Osaka, 540-0006
    Japan

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  • Amsterdam, 1081 HV
    Netherlands

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  • Hoofddorp, 2134 TM
    Netherlands

    Site Not Available

  • Leeuwarden, 8901 BR
    Netherlands

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  • Leiden, 2333 ZA
    Netherlands

    Site Not Available

  • Aveiro, 3810-096
    Portugal

    Site Not Available

  • Coimbra, 3030-075
    Portugal

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  • Lisboa, 1649-035
    Portugal

    Site Not Available

  • Porto, 4099-001
    Portugal

    Site Not Available

  • Hospitalet de Llobregat, Barcelona 08907
    Spain

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  • Sabadell, Barcelona 08208
    Spain

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  • Barcelona, 08035
    Spain

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  • Madrid, 28041
    Spain

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    Málaga, 29010
    Spain

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  • Málaga, 29010
    Spain

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  • Sevilla, 41013
    Spain

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  • Chur, Graubünden 7000
    Switzerland

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    Genève, 1211
    Switzerland

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  • Genève, 1211
    Switzerland

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  • Ankara, 06500
    Turkey

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  • Instanbul, 34662
    Turkey

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  • Istanbul, 34390
    Turkey

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  • Izmir, 35100
    Turkey

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  • Beverly Hills, California 90211
    United States

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  • Los Angeles, California 90033
    United States

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  • Mission Hills, California 91345
    United States

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  • Orange, California 92868
    United States

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  • Redlands, California 92374
    United States

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  • Santa Maria, California 93454
    United States

    Site Not Available

  • Aventura, Florida 33180
    United States

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  • Jacksonville, Florida 32224
    United States

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  • Peoria, Illinois 61615-7828
    United States

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  • Cedar Rapids, Iowa 52403
    United States

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  • New Orleans, Louisiana 70121
    United States

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  • Ann Arbor, Michigan 48106
    United States

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  • Rochester, Minnesota 55905
    United States

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  • St. Cloud, Minnesota 56303
    United States

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  • Jefferson City, Missouri 65109
    United States

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  • Neptune, New Jersey 07754
    United States

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  • New York, New York 10011
    United States

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  • Fargo, North Dakota 58122
    United States

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  • Toledo, Ohio 43623
    United States

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  • Scranton, Pennsylvania 18510
    United States

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  • Charleston, South Carolina 29414
    United States

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  • Sumter, South Carolina 29150
    United States

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  • Dallas, Texas 75390-9110
    United States

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  • Salt Lake City, Utah 84106
    United States

    Site Not Available

  • Green Bay, Wisconsin 54303
    United States

    Site Not Available

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