A Phase 3 Randomized, Double-blind Trial of Trilaciclib versus Placebo in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer
Some cancer treatments can suppress the production blood cells that we need to be healthy. One such cancer treatment used to treat colorectal cancer is a regimen that uses a combination of folinic acid (leucovorin), fluorouracil (5FU), irinotecan and oxaliplatin. While this is an effective treatment for colorectal cancer it has a serious side-effect called myelosuppression.
Myelosuppression is a condition in which bone marrow activity is suppressed resulting in fewer red and white blood cells as well as platelets. Red blood cells carry oxygen throughout our bodies. Fewer red cells lead to less oxygen in our tissues which causes fatigue, among other issues. White cells fight infection so fewer white cells makes us more susceptible to infections. Blood clots are formed by platelets. Fewer platelets can lead to bleeding issues. Chemotherapies that cause myelosuppression must be closely monitored. If blood counts drop too much, then the cancer treatment must be modified or changed. This can result in a less effective treatment for cancer. This study uses a drug called Trilaciclib to see if it is an effective option to treat CIM (chemo induced myelosuppression).
Due to the toxicity of FOLFOXIRI many clinicians limit its use to younger, generally healthier people. This limits treatment choices for older patients. Many clinical trials using FOLFOXIRI limit participants to those under 70 years of age. As the median age of colorectal diagnoses in men in the US is 68 and 72 for women, these people are not considered for this treatment regimen.
Currently, there are no approved treatments to prevent the cell damage leading to CIM. While there are therapies that help address CIM once they have occurred there are no current options to protect patients from the cell damage to begin with.
Trilaciclib is a highly potent and selective, reversible, CDK4/6 inhibitor. It is given intravenously (IV) before chemotherapy and is designed to preserve the cells from damage that leads to CIM. It also enhances anti-tumor activity. The objectives of this study are to assess the myelopreservation and anti-tumor effectiveness of Trilaciclib administered before FOLFOXIRI in patients with metastatic colorectal cancer.
If you are interested in more information on this study, please contact us. Refer to the study by the title listed above. You can also find information on this study by going to clinicaltrials.gov website and searching for NCT04607668.