Treatment of HER2-positive Colorectal Cancer as First Line Treatment in the Metastatic Setting
Clinicaltrials.gov identifier:
NCT05253651
Treatment
People with HER2-positive colorectal cancer who have not yet received treatment in the metastatic setting
Study Contact Information:
For additional information, please contact:
Seagen Trial Information Support at (866)333-7436 or [email protected]
Comparing a Combination of Drugs for Treatment of HER2-positive Colorectal Cancer as First Line Treatment in the Metastatic Setting
About the Study
This study is being done to decide if the drug Tukysa (Tucatinib) combined with other cancer drugs works better than the standard of care, which is chemotherapy treatment for people with a specific type of colorectal cancer called positive colorectal cancer. The study also aims to understand the side effects of the combination of these drugs in treatment.
The combination of drugs being used are Tukysa (Tucatinib), Herceptin (Trastuzumab), and mFOLFOX6, which is a combination of Oxaliplatin, Leucovorin, Levoleucovorin, and Fluorouracil.
What the Study Involves
People in this study will be divided at random into two groups:
Group 1
Patients will receive a combination of treatments.
- Tukysa will be received orally twice a day,
- Herceptin will be injected into the vein (intravenously) on cycle 1 day 1, then every three weeks after,
- and mFOLFOX6 will be given intravenously every 2 weeks.
Group 2
Patients will receive the standard of care treatment. They will receive either:
(1) mFOLFOX6 injected into the vein (intravenously) every 2 weeks,
(2) mFOLFOX6 intravenously every 2 weeks and Avastin (Bevacizumab) intravenously every 2 weeks, or
(3) mFOLFOX6 intravenously every 2 weeks and Erbitux (Cetuximab) intravenously on cycle 1 day 1, followed by another treatment every week.
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City: Kobe-shi RECRUITING
Facility: Kobe City Hospital Organization Kobe City Medical Center General Hospital
Contact Info:
Hisateru Yasui
Country: Japan
State: Other
City: Koto-ku RECRUITING
Facility: The Cancer Institute Hospital of JFCR
Contact Info:
Kensei Yamaguchi
Country: Japan
State: Other
City: Matsuyama-shi RECRUITING
Facility: NHO Shikoku Cancer Center
Contact Info:
Tomohiro Nishina
Country: Japan
State: Other
City: Osaka-shi RECRUITING
Facility: National Hospital Organization Osaka
Contact Info:
Takeshi Kato
Country: Japan
State: Other
City: Osaka-shi RECRUITING
Facility: Osaka General Medical Center (Kyuseiki Sogo Iryo C)
Contact Info:
Yujiro Nishizawa
Country: Japan
State: Other
City: Osakasayama-Shi RECRUITING
Facility: Kindai University Hospital
Contact Info:
Chiaki Inagaki
Country: Japan
State: Other
City: Sapporo-shi RECRUITING
Facility: National Hospital Organization Hokkaido Cancer Center
Contact Info:
Yoshito Komatsu
Country: Japan
State: Other
City: Suita-shi RECRUITING
Facility: Osaka University Hospital
Contact Info:
Taroh Satoh
Country: Japan
State: Other
City: Takatsuki-shi RECRUITING
Facility: Osaka Medical and Pharmaceutical University Hospital
Contact Info:
Toshifumi Yamaguchi
Country: Japan
State: Other
City: Yokohama RECRUITING
Facility: Kanagawa Cancer Center
Contact Info:
Nozomu Machida
Country: Korea, Republic of
State: Other
City: Incheon RECRUITING
Facility: Gachon University Gil Medical Center
Contact Info:
SunJin Sym
Country: Korea, Republic of
State: Other
City: Seoul RECRUITING
Facility: Korea University Anam Hospital
Contact Info:
SooHyeon Lee
Country: Korea, Republic of
State: Other
City: Seoul RECRUITING
Facility: Seoul National University Hospital
Contact Info:
Sae-Won Han
Country: Korea, Republic of
State: Other
City: Seoul RECRUITING
Facility: Severance Hospital, Yonsei University Health System
Contact Info:
Seung-Hoon Beom
Country: Korea, Republic of
State: Other
City: Seoul RECRUITING
Facility: Asan Medical Center - Oncology
Contact Info:
Sun Young Kim
Country: Korea, Republic of
State: Other
City: Seoul RECRUITING
Facility: Korea University Guro Hospital
Contact Info:
Sang Cheul Oh
Country: Korea, Republic of
State: Other
City: Seoul RECRUITING
Facility: Samsung Medical Center
Contact Info:
Seung Tae Kim
Country: Netherlands
State: Other
City: Amsterdam RECRUITING
Facility: Netherlands Cancer Institute
Contact Info:
Myriam Chalabi
Country: Netherlands
State: Other
City: Nieuwegein RECRUITING
Facility: St. Antonius Hospital
Contact Info:
Maartje Los
Country: Netherlands
State: Other
City: Venlo RECRUITING
Facility: VieCuri Medisch Centrum
Contact Info:
Hanneke Vestjens
Country: Norway
State: Other
City: Bergen RECRUITING
Facility: Haukeland Universitetssjukehus
Contact Info:
Inger Marie Loes
Country: Norway
State: Other
City: Oslo RECRUITING
Facility: Oslo University Hospital
Contact Info:
Jorgen Smeby
Country: Poland
State: Other
City: Gdansk RECRUITING
Facility: Katedra i Klinika Onkologii i Radioterapii
Contact Info:
Ewa Szutowicz
Country: Poland
State: Other
City: Konin RECRUITING
Facility: Przychodnia Lekarska KOMED Roman Karaszewski
Contact Info:
Boguslawa Karaszewska
Country: Poland
State: Other
City: Lodz RECRUITING
Facility: Salve Medica
Contact Info:
Monika Kukulska
Country: Poland
State: Other
City: Rzeszow RECRUITING
Facility: Mruk-Med - Sp. z o.o.
Contact Info:
Andrzej Mruk
Country: Poland
State: Other
City: Warsaw RECRUITING
Facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
Contact Info:
Lucjan Wyrwicz, MD
Country: Portugal
State: Other
City: Guarda RECRUITING
Facility: Hospital Sousa Martins
Contact Info:
Maria Ines Sequeira
Country: Portugal
State: Other
City: Lisboa RECRUITING
Facility: The Champalimaud Centre for the Unknown
Contact Info:
Nuno Couto
Country: Portugal
State: Other
City: Porto RECRUITING
Facility: Centro Hospitalar Universitario do Porto - Hospital Geral de Santo Antonio
Contact Info:
Sergio Azevedo
Country: Slovakia
State: Other
City: Bratislava RECRUITING
Facility: Narodny Onkologicky Ustav
Contact Info:
Stefan Porsok
Country: Spain
State: Other
City: Alicante RECRUITING
Facility: Hospital General Universitario Alicante
Contact Info:
Ana Lucia Yuste Izquierdo
Country: Spain
State: Other
City: Barcelona RECRUITING
Facility: Hospital Universitari Vall d'Hebron
Contact Info:
Maria Elena Elez Fernandez
Country: Spain
State: Other
City: Barcelona RECRUITING
Facility: Hospital Clinic de Barcelona
Contact Info:
Joan Maurel Santasusana
Country: Spain
State: Other
City: Barcelona RECRUITING
Facility: Institut Catala d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
Contact Info:
Cristina Santos Vivas
Country: Spain
State: Other
City: Cordoba RECRUITING
Facility: Hospital Universitario Reina Sofia
Contact Info:
Gema Guadalupe Pulido Cortijo
Country: Spain
State: Other
City: Lleida RECRUITING
Facility: Hospital Universitari Arnau de Vilanova
Contact Info:
Maria Antonia Salud Salvia
Country: Spain
State: Other
City: Madrid RECRUITING
Facility: Hospital General Universitario Gregorio Maranon
Contact Info:
Pilar Garcia Alfonso
Country: Spain
State: Other
City: Madrid RECRUITING
Facility: Hospital Universitario Ramon y Cajal
Contact Info:
Maria Reyes Ferreiro Monteagudo
Country: Spain
State: Other
City: Madrid RECRUITING
Facility: Hospital Universitario 12 de Octubre
Contact Info:
Cristina Gravalos Castro
Country: Spain
State: Other
City: Madrid RECRUITING
Facility: Hospital Universitario La Paz
Contact Info:
Nuria Rodriguez Salas
Country: Spain
State: Other
City: Malaga RECRUITING
Facility: Hospital Regional Universitario de Malaga - Hospital General
Contact Info:
Julia Alcaide Garcia
Country: Spain
State: Other
City: Ourense RECRUITING
Facility: Complejo Hospitalario Universitario de Ourense (CHOU)
Contact Info:
Ana Fernandez Montes
Country: Spain
State: Other
City: Oviedo RECRUITING
Facility: Hospital Universitario Central de Asturias
Contact Info:
Paula Jimenez Fonseca
Country: Spain
State: Other
City: Pamplona RECRUITING
Facility: Complejo Hospitalario de Navarra
Contact Info:
Ruth Vera Garcia
Country: Spain
State: Other
City: Santander RECRUITING
Facility: Hospital Universitario Marques de Valdecilla
Contact Info:
Fernando Rivera Herrero
Country: Spain
State: Other
City: Sevilla RECRUITING
Facility: Hospital Universitario Virgen del Rocio
Contact Info:
Manuel Jesus Valladares Ayerbes
Country: Spain
State: Other
City: Valencia RECRUITING
Facility: Consorcio Hospital General Universitario de Valencia (CHGUV)
Contact Info:
Maria Jose Safont Aguilera
Country: Spain
State: Other
City: Zaragoza RECRUITING
Facility: Hospital Universitario Miguel Servet
Contact Info:
Vicente Alonso Orduna
Country: Switzerland
State: Other
City: Winterthur RECRUITING
Facility: Kantonsspital Winterthur (KSW)
Contact Info:
Sabina Schacher
Country: Switzerland
State: Other
City: Zurich RECRUITING
Facility: Universitatsspital Zurich
Contact Info:
Ralph Fritsch
Country: Taiwan
State: Other
City: Kaohsiung City RECRUITING
Facility: Chang Gung Memorial Hospital - Kaohsiung
Contact Info:
Hong-Hwa Chen
Country: Taiwan
State: Other
City: Tainan RECRUITING
Facility: National Cheng-Kung University Hospital
Contact Info:
Yu-Min Yeh
Country: Taiwan
State: Other
City: Taipei RECRUITING
Facility: National Taiwan University Hospital
Contact Info:
Kun-Huei Yeh
Country: Taiwan
State: Other
City: Taipei City RECRUITING
Facility: Taipei Veterans General Hospital
Contact Info:
Hao-Wei Teng
Country: Taiwan
State: Other
City: Taoyuan RECRUITING
Facility: Chang Gung Memorial Hospital - Linkou
Contact Info:
Hung-Chih Hsu
Country: United Kingdom
State: Other
City: Bristol RECRUITING
Facility: University Hospitals Bristol and Weston NHS Foundation Trust
Contact Info:
Stephen John Falk
Country: United Kingdom
State: Other
City: Cambridge RECRUITING
Facility: Cambridge University Hospitals NHS Foundation Trust
Contact Info:
Karen McAdam
Cheryl Palmer
Country: United Kingdom
State: Other
City: Glasgow RECRUITING
Facility: The Beatson West of Scotland Cancer Centre
Contact Info:
Janet Graham
Country: United Kingdom
State: Other
City: Leeds RECRUITING
Facility: Leeds Teaching Hospitals Trust
Contact Info:
Jenny Seligmann
Country: United Kingdom
State: Other
City: London RECRUITING
Facility: Guy's and St Thomas' NHS Foundation
Contact Info:
Paul Ross
Country: United Kingdom
State: Other
City: London RECRUITING
Facility: The Royal Marsden NHS Foundation Trust (RM)
Contact Info:
David Cunningham
Country: United Kingdom
State: Other
City: London RECRUITING
Facility: Imperial College Healthcare NHS Trust
Contact Info:
Harpreet Wasan
Country: United Kingdom
State: Other
City: Manchester RECRUITING
Facility: The Christie NHS Foundation Trust
Contact Info:
Saifee Mullamitha
Country: United Kingdom
State: Other
City: Newcastle upon Tyne RECRUITING
Facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust
Contact Info:
Michelle Louise Cunnell
Country: United Kingdom
State: Other
City: Surrey RECRUITING
Facility: The Royal Marsden NHS Foundation Trust (RM)
Contact Info:
David Cunningham
People 18 years or older who:
- have colorectal or rectal cancer which is or not able to be removed through surgery who have not yet received treatment in the setting
- have cancer determined by a tissue-based test
- can provide a sample of your tumor tissue before starting the study
- have cancer able to be measured by XRAY showing that the cancer has progressed in a location that was already treated or an area of cancer that has not previously been treated
- have no evidence of cancer that has spread to the brain
- have previously treated brain metastases that are not causing symptoms
People who have:
- received prior treatment for their colorectal cancer
- received radiation therapy within the 14 days prior to enrollment
- received prior treatment with anti-HER2 therapy
- had a hole that developed through the small or large intestine (GI perforation/damage) within 12 months before starting the trial
- an ongoing Grade 3 or higher neuropathy (damage to the nervous system)