Frontiers in Oncology (Nov 2012)

An open-label, dose-finding study of the combination of satraplatin and gemcitabine in patients with advanced solid tumors

  • Eugenio eDonato Di Paola,
  • Eugenio eDonato Di Paola,
  • Silvia eAlonso,
  • Rosa eGiuliani,
  • Fabio eCalabrò,
  • Antonietta eD'Alessio,
  • Giovanni eRegine,
  • Linda eCerbone,
  • Laura eBianchi,
  • Andrea eMancuso,
  • Sabine eSperka,
  • Marcel eRozencweig,
  • Cora N Sternberg

DOI
https://doi.org/10.3389/fonc.2012.00175
Journal volume & issue
Vol. 2

Abstract

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PurposeSatraplatin is a third generation oral platinum, which has demonstrated antitumor activity. The aim of this Phase I study was to determine the maximum tolerated dose (MTD) of the combination of satraplatin and gemcitabine in patients previously treated with chemotherapy and in patients without prior chemotherapy.Patients and MethodsTwo separate MTDs were planned in 2 different patient groups (those with and without prior chemotherapy treatment). Dose escalations were planned in cohorts of 3 patients. Tumor measurements were obtained every 2 cycles. Assessment of response was performed according to Response Evaluation Criteria in Solid Tumors (RECIST criteria v.1.0).ResultsThirty subjects were enrolled. A MTD of gemcitabine 1000 mg/m2 d1 and 8 plus satraplatin 60 mg/m2 d1-3, every 21 days was determined in the prior chemotherapy group. No MTD could be determined for the no prior chemotherapy group treated with this schedule. Five patients completed 12 treatment cycles; 22 serious adverse events (SAE) were observed. Although not an entry criteria, overall confirmed response was observed in 17 (24%) evaluable patients (CR=1 and PR=3) and in 3/7 (43%) patients with measure prostate cancer lesions.ConclusionsIn this phase Ib study, the combination of satraplatin and gemcitabine demonstrated to be safe and efficacious in particular in patients with prostate cancer.

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