Phase I trial of fludarabine and paclitaxel in non-Hodgkin's lymphoma

Muhammad R. Abbasi, Joseph A. Sparano, Catherine Sarta, Peter H. Wiernik

Research output: Contribution to journalArticlepeer-review

3 Scopus citations


Fludarabine is an active agent in low-grade non-Hodgkin's lymphoma and chronic lymphocytic leukemia. Paclitaxel is also active in patients with refractory lymphoma, and preclinical data suggest an additive effect with fludarabine in vitro. We performed a phase I trial of fludarabine (25 mg/m2 d 1-3) plus a 3-h infusion of paclitaxel (125,150, or 175 mg/m2) on d 3 every 28 d in 13 patients with non-Hodgkin's lymphoma. The paclitaxel dose was escalated in cohorts of 3-4 patients using standard phase I design schema. Dose-limiting toxicity was defined as febrile neutropenia, platelet nadir less than 50,000/μL, or grade 3-4 nonhematologic toxicity. Thirteen patients were accrued to the study, 8 of these 13 patients (62%) had received prior chemotherapy. At the 125-, 150-, and 175-mg/m2 dose levels of paclitaxel, dose-limiting toxicity occurred in 1/4, 0/4, and 0/4 patients, respectively. The single patient with dose-limiting toxicity had febrile neutropenia. Partial response occurred in two of eight patients with low-grade lymphoma and none of five patients with other types of lymphoma. A paclitaxel dose of 175 mg/m2 given as a 3-h infusion on d 3 in conjunction with fludarabine (25 mg/m2 d 1-3 every 4 wk) is a well-tolerated regimen for non-Hodgkin's lymphoma. Further study will be required in order to determine whether the fludarabine-paclitaxel is more active than fludarabine alone in patients with low-grade lymphoma and chronic lymphocytic leukemia.

Original languageEnglish (US)
Pages (from-to)53-58
Number of pages6
JournalMedical Oncology
Issue number1
StatePublished - 2003
Externally publishedYes


  • Fludarabine
  • Non-Hodgkin's lymphoma
  • Paclitaxel
  • Phase I trial

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research


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