Abstract | PURPOSE: 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/m(2) days 1 and 8 plus satraplatin 60 mg/m(2) 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:
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Authors | Eugenio Donato Di Paola, Silvia Alonso, Rosa Giuliani, Fabio Calabrò, Antonietta D'Alessio, Giovanni Regine, Linda Cerbone, Laura Bianchi, Andrea Mancuso, Sabine Sperka, Marcel Rozencweig, Cora N Sternberg |
Journal | Frontiers in oncology
(Front Oncol)
Vol. 2
Pg. 175
( 2012)
ISSN: 2234-943X [Electronic] Switzerland |
PMID | 23189269
(Publication Type: Journal Article)
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