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.
Study Sites
Arizona
Glendale
Palo Verde Cancer Specialist
Contact: Deepak Nayak (602)978-6255 [email protected]
Phoenix
Mayo Clinic Arizona
Contact: Raquel Hawkins (480)574-2602 [email protected]
California
Anaheim
Pacific Cancer Medical Center
Contact: Elizabeth Brown [email protected]
Los Angeles
Los Angeles Cancer Network
Contact: Tania Biswas (213)977-1214 [email protected]
Los Angeles
Kaiser Permanente Southern California
Contact: Susan Nottmeier (626)372-5186 [email protected]
Santa Rosa
Saint Joseph Heritage Medical Group
Contact: Teresa Lund [email protected]
Colorado
Denver
Rocky Mountain Cancer Centers
Contact: Jennifer Hege [email protected]
Florida
Miami Beach
Mount Sinai Medical Center
Contact: Ana Lacombe (305)674-2625 x55860 [email protected]
Pensacola
Woodlands Medical Specialists
Contact: Leslie Bellamy (850)696-4423 [email protected]
Kentucky
Lexington
Baptist Health Lexington
Contact: Shelby Gambrell (859)639-7930 [email protected]
Louisville
Norton Cancer Institute
Contact: Christine Johnson (502)394-3650 [email protected]
Minnesota
Rochester
Mayo Clinic Rochester
Contact: Kathleen Wittenberger (507)293-2512 [email protected]
Saint Louis Park
HealthPartners Institute
Contact: Delaney Anderson (952)993-8379 [email protected]
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 [email protected]
North Carolina
Durham
Duke University Medical Center
Contact: Sabina Wlazlo Cascalherio (919)613-4812 [email protected]
Pinehurst
FirstHealth of the Carolinas
Contact: Julie Williams (910)715-1992 [email protected]
Oregon
Portland
Providence Portland Medical Center
Contact: Mary McCormick (503)216-3116 [email protected]
South Dakota
Sioux Falls
Avera Cancer Institute
Contact: Heidi Nickles (605)322-3295 [email protected]
Texas
Dallas
Texas Oncology - Baylor Sammons Cancer Center
Contact: Jonathan Huntzinger (214)370-1000 [email protected]
Houston
MD Anderson Cancer Center / University of Texas
Contact: Tracy Trevino (713)792-0622 [email protected]
McKinney
Texas Oncology - McKinney
Contact: Christy DeCastro (214)491-5945 [email protected]
Paris
Texas Oncology - Paris
Contact: Sue Crumpler (903)785-0031 [email protected]
Virginia
Roanoke
Oncology and Hematology Association of SW VA DBA Blue Ridge Cancer Care
Contact: Natasha Holt (540)808-1704 [email protected]
Washington
Everett
Providence Regional Medical Center Everett
Principal Investigator: Ajay Kundra
Vancouver
Northwest Cancer Specialists, P.C.
Contact: Susan Papenfuse (390)449-6521 [email protected]
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)