Original Research ARTICLE

Front. Oncol., 22 November 2012 | http://dx.doi.org/10.3389/fonc.2012.00175

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

Eugenio Donato Di Paola1,2, Silvia Alonso1, Rosa Giuliani1, Fabio Calabrò1, Antonietta D’Alessio1, Giovanni Regine3, Linda Cerbone1, Laura Bianchi1, Andrea Mancuso1, Sabine Sperka4, Marcel Rozencweig5 and Cora N. Sternberg1*
  • 1Department of Medical Oncology, San Camillo and Forlanini Hospitals, Rome, Italy
  • 2Department of Science of Health, School of Medicine, University “Magna Graecia”, Catanzaro, Italy
  • 3Department of Radiology, San Camillo and Forlanini Hospitals Rome, Italy
  • 4Clinical Operations, Agennix AG, Heidelberg, Germany
  • 5GPC Biotech Inc., Princeton, NJ, USA

Purpose: Satraplatin 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 Methods: Two separate MTDs were planned in two different patient groups (those with and without prior chemotherapy treatment). Dose escalations were planned in cohorts of three patients. Tumor measurements were obtained every two cycles. Assessment of response was performed according to Response Evaluation Criteria in Solid Tumors (RECIST criteria v.1.0). Results: Thirty subjects were enrolled. A MTD of gemcitabine 1000 mg/m2 days 1 and 8 plus satraplatin 60 mg/m2 days 1–3, 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 (complete response, CR = 1 and partial response, PR = 3) and in 3/7 (43%) patients with measure prostate cancer lesions. Conclusions: In this phase Ib study, the combination of satraplatin and gemcitabine demonstrated to be safe and efficacious in particular in patients with prostate cancer.

Keywords: satraplatin, oral platinum, phase I study, prostate cancer, solid tumors, chemotherapy

Citation: Donato Di Paola E, Alonso S, Giuliani R, Calabrò F, D’Alessio A, Regine G, Cerbone L, Bianchi L, Mancuso A, Sperka S, Rozencweig M and Sternberg CN (2012) An open-label, dose-finding study of the combination of satraplatin and gemcitabine in patients with advanced solid tumors. Front. Oncol. 2:175. doi: 10.3389/fonc.2012.00175

Received: 17 August 2012; Paper pending published: 12 September 2012;
Accepted: 05 November 2012; Published online: 22 November 2012.

Edited by:

Ganesh V. Raj, University of Texas Southwestern Medical Center, USA

Reviewed by:

Scott T. Tagawa, Weill Cornell Medical College, USA
Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, USA

Copyright: © 2012 Donato Di Paola, Alonso, Giuliani, Calabrò, D’Alessio, Regine, Cerbone, Bianchi, Mancuso, Sperka, Rozencweig and Sternberg. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in other forums, provided the original authors and source are credited and subject to any copyright notices concerning any third-party graphics etc.

*Correspondence: Cora N. Sternberg, Department of Medical Oncology, San Camillo and Forlanini Hospitals, Padiglione Flajani, 1st Floor, Circonvallazione Gianicolense 87, 00152 Rome, Italy. e-mail: cstern@mclink.it