Phase I trial of fixed-dose rate gemcitabine in combination with bortezomib in advanced solid tumors

Thehang Luu, Warren Chow, Dean Lim, Marianna Koczywas, Paul Frankel, Mihaela Cristea, Kim Margolin, James H. Doroshow, George Somlo, Shikha Gaur, Yun Yen, Robert J. Morgan

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6 Citations (Scopus)

Abstract

Background: Bortezomib demonstrates synergism with gemcitabine via a fixed-dose rate (FDR). The aim of this phase I trial in solid tumors was to establish the maximum tolerated dose (MTD) and safety data for this combination. Patients and Methods: Twenty-nine patients with a median age of 63 (range 36-84) years and median Karnofsky Performance Status of 90 (range 60-100) were enrolled and treated with bortezomib (1.0 or 1.3 mg/m2) on days 1, 4, 8 and 11 and FDR gemcitabine (750, 1,000, or 1,250 mg/m2) on days 1 and 8 of each 21-day cycle. Response was evaluated every two cycles. Results: Dose-limiting toxicities were grade 4 thrombocytopenia and neutropenia and grade 3 liver function test abnormalities. The MTD was bortezomib 1 mg/m2 and FDR gemcitabine 1,250 mg/m2. The median number of cycles delivered was 3 (range 1-28). There was one partial response and six cases of stable disease. The median duration of response was 8.5 (range 3-20) months. Conclusion: FDR gemcitabine and bortezomib combination can be delivered effectively with acceptable toxicity.

Original languageEnglish
Pages (from-to)167-174
Number of pages8
JournalAnticancer Research
Volume30
Issue number1
Publication statusPublished - Jan 1 2010
Externally publishedYes

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Keywords

  • Bortezomib
  • Fixed-dose rate gemcitabine
  • Phase I
  • Solid tumors

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Luu, T., Chow, W., Lim, D., Koczywas, M., Frankel, P., Cristea, M., Margolin, K., Doroshow, J. H., Somlo, G., Gaur, S., Yen, Y., & Morgan, R. J. (2010). Phase I trial of fixed-dose rate gemcitabine in combination with bortezomib in advanced solid tumors. Anticancer Research, 30(1), 167-174.