Trametinib and Trifluridine and Tipiracil Hydrochloride in Treating Patients With Colon or Rectal Cancer That is Advanced, Metastatic, or Cannot Be Removed by Surgery
NCT03317119 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26
Last updated 2024-04-08
Summary
This phase I trial studies the side effects and best dose of trametinib and trifluridine and tipiracil hydrochloride in treating patients with colon or rectal cancer that has spread to other places in the body (advanced/metastatic) or cannot be removed by surgery. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as trifluridine and tipiracil hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving trametinib and trifluridine and tipiracil hydrochloride may prevent cancer cells from dividing and work better in treating patients with colon and rectal cancer.
Conditions
- Metastatic Colon Carcinoma
- Metastatic Colorectal Carcinoma
- Metastatic Rectal Carcinoma
- RAS Family Gene Mutation
- Stage III Colon Cancer AJCC v7
- Stage III Colorectal Cancer AJCC v7
- Stage III Rectal Cancer AJCC v7
- Stage IIIA Colon Cancer AJCC v7
- Stage IIIA Colorectal Cancer AJCC v7
- Stage IIIA Rectal Cancer AJCC v7
- Stage IIIB Colon Cancer AJCC v7
- Stage IIIB Colorectal Cancer AJCC v7
- Stage IIIB Rectal Cancer AJCC v7
- Stage IIIC Colon Cancer AJCC v7
- Stage IIIC Colorectal Cancer AJCC v7
- Stage IIIC Rectal Cancer AJCC v7
- Stage IV Colon Cancer AJCC v7
- Stage IV Colorectal Cancer AJCC v7
- Stage IV Rectal Cancer AJCC v7
- Stage IVA Colon Cancer AJCC v7
- Stage IVA Colorectal Cancer AJCC v7
- Stage IVA Rectal Cancer AJCC v7
- Stage IVB Colon Cancer AJCC v7
- Stage IVB Colorectal Cancer AJCC v7
- Stage IVB Rectal Cancer AJCC v7
Interventions
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- DRUG
-
Trametinib
Given PO
- DRUG
-
Trifluridine and Tipiracil Hydrochloride
Given PO
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
City of Hope Medical Center
lead OTHER
Principal Investigators
-
Marwan G Fakih · City of Hope Medical Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-04-11
- Primary Completion
- 2023-07-14
- Completion
- 2023-07-14
- FDA Drug
- Yes
Countries
- United States
Study Locations
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