Phase I Study of the Cyclin-Dependent Kinase Inhibitor Flavopiridol in Combination With Paclitaxel in Patients With Advanced Solid Tumors

Paclitaxel was administered at a fixed dose, as either a 24- or 3-hour infusion on day 1, followed by a 24-hour infusion of flavopiridol on day 2

Gary K. Schwartz; Eileen O’Reilly; David Ilson; Leonard Saltz; Sunil Sharma; William Tong; Peter Maslak; Maxine Stoltz; Larry Eden; Pam Perkins; Sandra Endres; John Barazzoul; David Spriggs; David Kelsen

2002

Scholarcy highlights

  • Paclitaxel was administered at a fixed dose, as either a 24- or 3-hour infusion on day 1, followed by a 24-hour infusion of flavopiridol on day 2
  • Dose-limiting neutropenia developed with 24-hour paclitaxel doses of 135 and 100 mg/m2 and flavopiridol doses of 10 and 20 mg/m2, respectively
  • With 3-hour paclitaxel escalated to 135 mg/m2, dose-limiting neutropenia and pulmonary toxicity occurred when flavopiridol was escalated to 94 mg/m2
  • At a 3-hour paclitaxel dose of 175 mg/m2, dose-limiting pulmonary toxicity occurred in only one patient at flavopiridol doses under 94 mg/m2
  • Clinical activity was observed in patients with esophagus, lung, and prostate cancer, including patients who had progressed on paclitaxel
  • The recommended phase II doses will be a 3-hour infusion of paclitaxel at 175 mg/m2 on day 1 followed by a 24-hour infusion of flavopiridol at 70 mg/m2 on day 2
  • Toxicities are manageable and clinical activity is promising

Need more features? Save interactive summary cards to your Scholarcy Library.