An Open‐label Phase 1 Dose‐escalation Clinical Trial of a Single Intravenous Administration of Gemcitabine in Dogs with Advanced Solid Tumors

摘要: Background A broad range of gemcitabine dosages have been used in dogs. Hypothesis/Objectives To determine maximally tolerated dose (MTD), dose-limiting toxicity (DLT), and preliminary antitumor activity intravenous administration dogs with advanced solid tumors. Animals Twenty-two client-owned dogs. Methods Dogs cancer were prospectively enrolled an open-label Phase 1 study gemcitabine. Gemcitabine was administered as a 30-minute bolus starting at 800 mg/m2, using escalation 50 mg/m2 increments 3 per level. MTD established based on the number experiencing DLT assessed after cycle. Treatment continued until disease progression or unacceptable toxicosis. Additional to better characterize tolerability, assess extent duration excretion. Results Twenty-two treated 4 levels, ranging from 800 950 mg/m2. Neutropenia identified DLT. 900 mg/m2. consisting grade febrile neutropenia observed 950 mg/m2 2 dogs. There no nonhematologic DLTs. Twenty received multiple doses, none had evidence severe toxicosis any their subsequent treatments. At 900 mg/m2, complete 5 partial responses measurable tumors. The amount excreted urine decreased over time, undetectable first 24 hours. Conclusions Clinical Importance The recommended for future studies is weekly In chemotherapy-naive tumor this level merits further evaluation.