Cancer Chemotherapy and Pharmacology

, Volume 68, Issue 5, pp 1119–1124

Phase I trial of metronomic oral vinorelbine in patients with advanced cancer

  • Lakshmi Rajdev
  • Abdissa Negassa
  • Qun Dai
  • Gary Goldberg
  • Kathy Miller
  • Joseph A. Sparano
Original Article



Antitubulin agents exhibit antiangiogenic effects in vitro and in vivo. We evaluated the safety and feasibility of administering a metronomic schedule of oral vinorelbine designed to optimize its antiangiogenic effects.


Patient with advanced cancer who had progressive disease after standard therapy received oral vinorelbine 3 times weekly (i.e., Monday, Wednesday, Friday) at the 6 dose levels ranging from 20 mg (1 week on, 1 week off) to 50 mg (3 weeks on, 1 week off) in cohorts of 3–6 patients at each dose level using a standard phase I design. Dose-limiting toxicity (DLT) during cycle 1 included: (1) neutrophil nadir < 500/μL attributed to therapy, (2) platelet nadir < 50,000/μL attributed to therapy, (3) grade 3–4 non-hematologic toxicity attributed to therapy, and (4) neutropenia associated with grade 2 fever (i.e., febrile neutropenia).


Nineteen patients received 50 cycles of therapy (range 1–11 cycles) at 6 dose levels. There were no dose-limiting toxic events. There were no consistent changes in serum TIE-2 or VCAM-1 levels, or urinary VEGF. One patient with renal cell carcinoma had stable disease for 9 months, and another patient with metastatic prostate cancer had a 70% decline in serum prostate-specific antigen, which lasted 4 months.


Oral vinorelbine may be given using a metronomic schedule, 50 mg thrice weekly for three of 4 weeks, with minimal toxicity in patients with advanced cancer.


Metronomic Oral Vinorelbine Advanced cancer 


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Copyright information

© Springer-Verlag 2011

Authors and Affiliations

  • Lakshmi Rajdev
    • 1
  • Abdissa Negassa
    • 2
  • Qun Dai
    • 3
  • Gary Goldberg
    • 4
  • Kathy Miller
    • 5
  • Joseph A. Sparano
    • 1
    • 4
  1. 1.Department of OncologyAlbert Einstein College of Medicine and Cancer Center, Montefiore Medical CenterBronxUSA
  2. 2.Department of Epidemiology and Population Health, Division of BiostaticsAlbert Einstein College of Medicine and Cancer CenterBronxUSA
  3. 3.Department of Medical OncologyStaten Island University HospitalStaten IslandUSA
  4. 4.Department of Obstetrics, Gynecology, and Women’s Health, Division of Gynecologic OncologyAlbert Einstein College of Medicine and Cancer Center, Montefiore Medical CenterBronxUSA
  5. 5.Department of Medicine, Division of Hematology/OncologyIndiana University School of MedicineIndianapolisUSA

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