A Phase Ib/II Study of the Safety and Pharmacology of Nilotinib to Prevent Paclitaxel-Induced Peripheral Neuropathy in Patients with Breast Cancer
This phase Ib/II trial studies the side effects and best dose of nilotinib in preventing paclitaxel-induced peripheral neuropathy in stage I-III breast cancer patients who are receiving paclitaxel therapy. Chemotherapy is the usual or ?standard? treatment for breast cancer. It kills cancer cells and lowers the chance that the cancer will come back. Sometimes, this treatment can cause numbness and tingling, especially in the hands and feet. This is called chemotherapy-induced peripheral neuropathy. This study aims to test the safety and effectiveness, both good and bad, of taking nilotinib in preventing chemotherapy-induced peripheral neuropathy.
• Men or Women with a known diagnosis of breast cancer stages I-III.
• Be eligible for weekly or dose dense single agent paclitaxel therapy based on physician assessment.
• Have an Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
⁃ Patients with ECOG scores of 3 or greater typically do not receive chemotherapeutic intervention.
• Leukocytes \>= 2,000/uL.
• Absolute neutrophil count \>= 1,500/uL.
• Platelets \>= 100,000/uL.
• Total bilirubin =\< upper limit of normal (ULN).
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional upper limit of normal.
• Creatinine within normal institutional limits OR \>= 50 mL/min for patients with creatinine levels above institutional normal.
• Corrected QT interval (QTc) \< 450 milliseconds.
• If a female subject is with child bearing potential, she must have a negative pregnancy test at screening.
• Female subjects of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation and for 3 months after completion of study treatment administration. Adequate contraception includes methods such as oral contraceptives, double barrier method (condom plus spermicide or diaphragm), or abstaining from sexual intercourse.
• Be willing and able to understand and sign the written informed consent document.