Our prediction tool for phase I clinical trial drug-related toxicity is designed to estimate a patient’s baseline risk of developing serious drug-related toxicity (SDRT) in the first cycle of the trial. This tool is to be used before a decision is made about a given patient’s participation in phase I cancer trials.
This tool should be used only for patients who do not have leukemia or lymphoma and who are entering trials where they will be treated with cytotoxic or molecularly targeted agents, alone or in combination. The tool should not be used for patients entering clinical trials testing vaccines, radiation therapy, or loco-regional therapy (therapy that affects only a specific area rather than the whole body [systemic]), or for patients on dedicated organ dysfunction trials.
In addition, patients must:
- Be 18 years of age or more
- Have solid tumors
- Have an absolute neutrophil count of at least 1 x 109/L
- Have a hemoglobin level of at least 8 g/dL
- Have a platelet count of at least 75 x 109/L
- Have aspartate aminotransferase (AST) equal to or less than 5 x upper limit of normal (ULN), alanine aminotransferase (ALT) equal to or less than 5 x ULN, and total bilirubin equal to or less than 2 x ULN
Results produced by this tool are based on data from more than 3,100 patients enrolled in 127 phase I trials sponsored by the National Cancer Institute’s Cancer Therapeutics Evaluation Program (CTEP). All results must be understood in the context of each patient’s specific treatment plan. If you are a patient, we recommend that you use this tool ONLY in consultation with your physician.
Use our Serious Drug-Related Toxicity in Phase I Clinical Trials prediction tool.