A Phase I Study of Pegylated Liposomal Doxorubicin Hydrochloride (Caelyx™) in Combination with Cyclophosphamide and Vincristine as Second-Line Treatment of Patients with Small-Cell Lung Cancer Academic Article uri icon

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  • The purpose of this study was to determine the recommended phase II dose of liposomal doxorubicin (Caelyx ; Doxil in the United States) in combination with cyclophosphamide and vincristine for previously treated patients with good performance status with relapsed or refractory small-cell lung cancer. Twenty-one eligible patients were enrolled between November 1999 and September 2001 and received liposomal doxorubicin 25-40 mg/m2, cyclophosphamide 750-1000 mg/m2, and vincristine 1.2 mg/m2 intravenously (I.V.) every 21 days. At doses of liposomal doxorubicin 40 mg/m2, cyclophosphamide 750 mg/m2, and vincristine 1.2 mg/m2 I.V., 1 of 6 patients had dose-limiting neutropenia and fever in cycle 2 and 2 of 6 developed grade 3 hand-foot syndrome during cycle 3. Therefore, the recommended phase II doses are liposomal doxorubicin 35 mg/m2, cyclophosphamide 750 mg/m2, and vincristine 1.2 mg/m2 I.V. every 21 days. Antitumor activity was seen at all dose levels. This combination is well tolerated and has evidence of antitumor activity. A phase II evaluation is ongoing.


  • Leighl, Natasha B
  • Burkes, Ronald L
  • Dancey, Janet E
  • Lopez, Pedro G
  • Higgins, Brian P
  • David Walde, PL
  • Rudinskas, Leona C
  • Rahim, Yasmin H
  • Rodgers, Angela
  • Pond, Gregory
  • Shepherd, Frances A

publication date

  • September 2003