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 clinicaltrials@seagen.com
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.
Study Sites
Arizona
Glendale
Palo Verde Cancer Specialist
Contact: Deepak Nayak (602)978-6255 dnayak@pvcancer.com
Phoenix
Mayo Clinic Arizona
Contact: Raquel Hawkins (480)574-2602 hawkins.raquel@mayo.edu
California
Anaheim
Pacific Cancer Medical Center
Contact: Elizabeth Brown elizabethg@pacificcancer.com
Los Angeles
Los Angeles Cancer Network
Contact: Tania Biswas (213)977-1214 tania.biswas@lahomg.com
Los Angeles
Kaiser Permanente Southern California
Contact: Susan Nottmeier (626)372-5186 susan.l.nottmeier@kp.org
Santa Rosa
Saint Joseph Heritage Medical Group
Contact: Teresa Lund teresa.lund@stjoe.org
Colorado
Denver
Rocky Mountain Cancer Centers
Contact: Jennifer Hege jennifer.hege@usoncology.com
Florida
Miami Beach
Mount Sinai Medical Center
Contact: Ana Lacombe (305)674-2625 x55860 ana.lancombe@msmc.com
Pensacola
Woodlands Medical Specialists
Contact: Leslie Bellamy (850)696-4423 lbellamy@woodlandsmed.com
Kentucky
Lexington
Baptist Health Lexington
Contact: Shelby Gambrell (859)639-7930 shelby.gambrell@bhsi.com
Louisville
Norton Cancer Institute
Contact: Christine Johnson (502)394-3650 christine.johnson@nortonhealthcare.org
Minnesota
Rochester
Mayo Clinic Rochester
Contact: Kathleen Wittenberger (507)293-2512 wittenberger.kathleen@mayo.edu
Saint Louis Park
HealthPartners Institute
Contact: Delaney Anderson (952)993-8379 delaney.anderson@parknicollet.com
Missouri
Kansas City
MidAmerica Cancer Center, LLC
Principal Investigator: Jaswinder Singh
New York
New York
Memorial Sloan Kettering Cancer Center
Contact: Jill Weiss (646)888-4327 weissj2@mskcc.org
North Carolina
Durham
Duke University Medical Center
Contact: Sabina Wlazlo Cascalherio (919)613-4812 sabina.wlazlo@duke.edu
Pinehurst
FirstHealth of the Carolinas
Contact: Julie Williams (910)715-1992 jcwilliams@firsthealth.org
Oregon
Portland
Providence Portland Medical Center
Contact: Mary McCormick (503)216-3116 mary.mccormick@providence.org
South Dakota
Sioux Falls
Avera Cancer Institute
Contact: Heidi Nickles (605)322-3295 heidi.nickles@avera.org
Texas
Dallas
Texas Oncology - Baylor Sammons Cancer Center
Contact: Jonathan Huntzinger (214)370-1000 jonathan.huntzinger@usoncology.com
Houston
MD Anderson Cancer Center / University of Texas
Contact: Tracy Trevino (713)792-0622 tltrevino@mdanderson.org
McKinney
Texas Oncology - McKinney
Contact: Christy DeCastro (214)491-5945 christy.decastro@usoncology.com
Paris
Texas Oncology - Paris
Contact: Sue Crumpler (903)785-0031 sue.crumpler@usoncology.com
Virginia
Roanoke
Oncology and Hematology Association of SW VA DBA Blue Ridge Cancer Care
Contact: Natasha Holt (540)808-1704 natasha.holt@usoncology.com
Washington
Everett
Providence Regional Medical Center Everett
Principal Investigator: Ajay Kundra
Vancouver
Northwest Cancer Specialists, P.C.
Contact: Susan Papenfuse (390)449-6521 susan.papenfuse@usoncology.com
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)