Phase 1 trial of gemcitabine with bortezomib in elderly patients with advanced solid tumors

Satya V. Bommakanti, Arkadiusz Z. Dudek, Amit Khatri, Mark N. Kirstein, Purvi D. Gada

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7 Scopus citations


Bortezomib, a proteasome inhibitor, has synergistic antitumor activity with gemcitabine, an antimetabolite, in preclinical and clinical studies. The safety of this combination has not yet been established in elderly patients; therefore, this dose-escalation study was designed to assess the maximum-tolerated dose of bortezomib and gemcitabine in patients aged 70 years or older with advanced-stage solid tumors. Patients and Methods: Gemcitabine was administered intravenously (800 to 1000 mg/m 2) over 30 minutes on days 1 and 8, followed 60 minutes later by bortezomib administered as an intravenous push over 3 to 5 seconds (1.0 to 1.8 mg/m 2) on a 21-day cycle. This study used a standard phase 1 dose-escalation design with 3 or 6 patients per dose level. Results: Seventeen patients with stage IV solid tumors were treated. Median age was 73 years (range: 70 to 87 y). All patients had an Eastern Cooperative Oncology Group (ECOG) performance status less than 2. Median number of earlier chemotherapy regimens was 2 (range: 0 to 6). Dose-limiting toxicities were seen in 2 of 8 patients enrolled at the second dose level of gemcitabine (1000 mg/m 2) and bortezomib (1.0 mg/m 2), which consisted of grade ≥3 lower extremity edema, thrombocytopenia, fatigue, and dehydration. The most common grade ≥3 toxicities included thrombocytopenia (n=9), neutropenia (n=6), and anemia (n=5). Partial response (n=3) or disease stabilization (n=3) was seen in 6 of 14 evaluable patients. Conclusions: Concurrent weekly gemcitabine (800 mg/m 2) and bortezomib (1 mg/m 2) is the recommended schedule for future phase 2 trials in elderly patients with stage IV solid tumors.

Original languageEnglish (US)
Pages (from-to)597-602
Number of pages6
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Issue number6
StatePublished - Dec 1 2011


  • bortezomib
  • cancer
  • clinical trial
  • elderly
  • gemcitabine

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