Riluzole in Combination With mFOLFOX6 and Bevacizumab in Treating Patients With Metastatic Colore⦠(NCT04761614) | Clinical Trial Compass
CompletedPhase 1
Riluzole in Combination With mFOLFOX6 and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer
United States13 participantsStarted 2021-04-02
Plain-language summary
This phase I trial is to find out the best dose, possible benefits, and/or side effects of riluzole and how well it works in combination with standard of care mFOLFOX6 and bevacizumab in treating patients with colorectal cancer that has spread to other places in the body (metastatic). Riluzole is a well-tolerated oral medication that has demonstrated it may make chemotherapy work better. Chemotherapy drugs, such as oxaliplatin, leucovorin calcium and fluorouracil, work in different ways to stop the growth of \[cancer/tumor\] cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab is an antibody that targets the blood vessel by blocking the activity of a protein called vascular endothelial growth factor alpha (VEGF-A). It helps to make the mFOLFOX6 more effective. Giving riluzole, mFOLFOX6, and bevacizumab may kill more tumor cells compared to mFOLFOX6 and bevacizumab alone in treating patients with colorectal cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients with metastatic colorectal cancer, who are appropriate candidates to receive mFOLFOX6/bevacizumab. Patients who progressed on FOLFOX-based regimen are allowed
* Willingness to undergo both pre-treatment and post-treatment tumor tissue biopsies (pre-treatment tumor tissue will be sent to pathology lab to confirm metastatic colorectal cancer as the standard of care)
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Age \>= 18 years
* Absolute neutrophil count \>= (ANC) 1,500/ul
* Platelets \>= 100,000/ul
* Hemoglobin \>= 9 g/dl
* Serum total bilirubin \< 1.5 x ULN
* Serum albumin \>= 2.5 g/dl
* If no liver involvement, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 1.5 x ULN. If liver involvement, AST and ALT =\< 3.0 x ULN
* Ability to understand and the willingness to sign a written informed consent document
* A male subject of fathering potential must use an adequate method of contraception to avoid conception throughout the study (and for up to 12 weeks after the last dose of study drug) to minimize the risk of pregnancy. If the partner is pregnant or breastfeeding, the subject must use a condom
* Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the last dose of study drug to minimize the risk of pregnancy. WOCBP must have a negative serum or urine pregnancy test within 72 hours before the stā¦
What they're measuring
1
Dose limiting toxicities (DLTs)
Timeframe: Up to 4 weeks (2 cycles of treatment) (1 cycle = 14 days)