A phase II study of flavopiridol in patients with advanced renal cell carcinoma: Results of Southwest Oncology Group Trial 0109

Peter J. Van Veldhuizen, James R. Faulkner, Primo N Lara, Paul H. Gumerlock, J. Wendall Goodwin, Shaker R. Dakhil, Howard M. Gross, Robert C. Flanigan, E. David Crawford

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27 Scopus citations


Purpose: Flavopiridol is a cyclin-dependent kinase inhibitor that prevents cell cycle progression and tumor growth. In initial phase I studies, encouraging responses were seen in advanced renal cell cancer (RCC). In a phase II study of flavopiridol given as a 72-h continuous infusion every 2 weeks in RCC, a response rate of 6% was seen but with considerable grade 3 or 4 asthenia, diarrhea, and thrombosis. Subsequently, an alternative 1-h bolus schedule was reported to have enhanced tolerability in a phase I trial. We therefore conducted a phase II study of this bolus regimen. Methods: A total of 38 patients with advanced RCC were entered into this multi-institutional phase II study. Flavopiridol (50 mg/m2 per day) was administered by bolus intravenous injection daily for three consecutive days, repeated every 3 weeks. Results: Out of 34 eligible patients, one complete response and three partial responses were observed, for an overall response rate of 12% (95% CI 3-27%). Of the 34 patients, 14 (41%) had stable disease (SD). The probability of not failing treatment by 6 months was 21% (95% CI 9-35%). Median overall survival time was 9 months (95% CI 8-18 months). The most common grade 3 or 4 toxicities were diarrhea (35%) and tumor pain (12%) along with anemia, dyspnea, and fatigue (9% each). Conclusions: Flavopiridol at this dose and schedule is feasible with an acceptable toxicity profile. Flavopiridol has some modest biologic activity against advanced RCC, as evidenced by its single-agent objective response and SD rates.

Original languageEnglish (US)
Pages (from-to)39-45
Number of pages7
JournalCancer Chemotherapy and Pharmacology
Issue number1
StatePublished - Jul 2005



  • Cyclin-dependent kinase inhibitor
  • Flavopiridol
  • Renal cell neoplasm

ASJC Scopus subject areas

  • Cancer Research
  • Pharmacology
  • Oncology

Cite this

Van Veldhuizen, P. J., Faulkner, J. R., Lara, P. N., Gumerlock, P. H., Goodwin, J. W., Dakhil, S. R., Gross, H. M., Flanigan, R. C., & Crawford, E. D. (2005). A phase II study of flavopiridol in patients with advanced renal cell carcinoma: Results of Southwest Oncology Group Trial 0109. Cancer Chemotherapy and Pharmacology, 56(1), 39-45. https://doi.org/10.1007/s00280-004-0969-9