Inproceedings: An article in a conference proceedings.
Abstract (Abstract): shot summary in a article that contain essentials elements presented during a scientific conference, lecture or from a poster.
Phase I study of the oral platinum agent satraplatin (S) in sequential combination with capecitabine (C) in patients with advanced solid tumours.
Title of the conference
2008 ASCO Annual Meeting
Chicago, Illinois, May 30-June 3 2008
Journal of Clinical Oncology
Background: S is a novel, oral platinum (P) analogue with a preclinical safety and activity profile comparable to carboplatin. C is an oral pro-drug of 5'-DFUR approved as single agent or in combination with other cytotoxic agents for the treatment of breast and colon cancer. A sequential administration schedule of S and C was assessed in an open-label phase Ib study in adult patients (pts) with advanced solid tumours. Methods: S was given QD to fasting pts from d1 to 5, C BID from d8 to 21 of a 4-week cycle. The starting daily doses were S 60 mg/m2 and C 1,650 mg/m2 (825 BID). Prophylactic oral 5HT 3 antagonists and steroids were given 30-60 min before S. Three to six pts were entered per dose level (DL). The maximum tolerated dose (MTD) was one dose level below the dose at which >2 of 3 or >2 of 6 pts experienced dose-limiting toxicities (DLTs). Eligibility criteria included ECOG PS <2, adequate renal/liver function, <2 lines of prior chemotherapies (CTs) for advanced disease, lack of resistance to approved P and/or fluoropyrimidine compounds, absence of clinical situations significantly affecting oral absorption. Results: 38 pts with a variety of solid tumours (20 prostate, 7 ovarian, 4 gastrointestinal, 7 other) entered the study at 4 Swiss centres (SAKK-SENDO phase I network). All pts but 1 (hormone-resistant prostate cancer) had received prior CTs, including P compounds in 13 pts. Dose-limiting thrombocytopenia G3-4 occurred in 2/6 pts at DL S 80 mg/m2 and C 1,650 mg/m2. The MTD and thus the RD was determined at S 70 mg/m2 and C 2,000 mg/m2, with DLT nausea G3 and long-lasting moderate neutropenia in 1/6 pts. Main non-haematological toxicities were nausea, anorexia, diarrhoea and mild to moderate fatigue. In 24 pts evaluated, 2 confirmed partial responses (PR) were seen in P-sensitive ovarian cancer, 1 PR and 4 stable diseases (SD) in prostate cancer pts. Conclusions: The phase II RD of the sequential combination has been defined at S 70 mg/m2 and C 2,000 mg/m2 (1,000 BID). Preliminary results suggest that the sequential administration of S and C represents a well tolerated and convenient oral treatment for pts with advanced solid tumours.
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