Dose finding study of the combination of satraplatin and gemcitabine in patients with advanced solid tumors

e13534 Background: The potential advantage of combining satraplatin (S) a novel oral platinum with Gem is attractive. MTD and DLT of combination S and Gem in patients (pts) with advanced solid tumors was evaluated. Methods: Cohorts of 3–6 pts (modified Fibonacci) received escalating doses of i.v. Gem on days (d) 1, 8 and 15 Q 28 d followed by oral S on d 1–5. Seventeen pts with metastatic solid tumors were separated into 2 groups: A) Pts that had progressed following cytotoxic therapy and B) Pts who had received no prior chemotherapy. Starting dose was Gem 800 mg in both groups, S 40 mg and 60 mg for A and B respectively. Results: Group A. 6 previously treated pts with 1 or 2 regimens (3 prostate, 1 hepatocarcinoma, 1 bladder and 1 thymic ca) received 25 cycles, median 2 (2–12). 2 DLTs (G3 transaminases) were observed in 6 pts treated at level 1. Other G3 major toxicities were: thrombocytopenia (1 pt) and diarrhea (1 pt). 2 pts had PSA declines, with TTP of 630 days in 1 of them. Group B. 11 pts with no prior chemotherapy (4 hepatocarcinoma, 4 pancreas, 1 renal, 1 unknown origin and 1 gallbladder), received 38 cycles, median 2 (1–12). 1 DLT (G3 diarrhea) was observed in 8 pts treated at level 1 (2 not evaluable; received Gem d1 only), DLT (G3 thrombocytopenia) was observed in 3 pts treated at level 2 (Gem 1000, S 60). Other G3 toxicities were: thrombocytopenia (3 pts) and neutropenia (3 pts). 1 CR (pancreas) and 1 PR (gallbladder) were observed. Gem d8 or d15 was omitted in 11 of 17 pts during the 1st cycle. Conclusions: In this study the combination of S and Gem showed a clinically acceptable toxicity profile with promising antitumor activity. However, since in cycle 1, it was not possible to administer Gem on both d8 and d15 on 11 occasions, a 2nd study was initiated with S d1–3 and Gem d1 and 8 given on a Q 21 d schedule. Sponsored by GPC Biotech No significant financial relationships to disclose.