BACKGROUND: Satraplatin is an oral platinum with potential advantages over other platinum agents. This study investigated the combination of satraplatin and docetaxel in a phase 1 study of patients with advanced solid tumor malignancies followed by a phase 1b study in men with chemotherapy naïve metastatic castrate-resistant prostate cancer (CRPC). METHODS: In this single institution phase 1/1b study, patients received docetaxel on day 1 and satraplatin on days 1-5 of a 21-day cycle ± granulocyte colony stimulating factor (GCSF). For phase 1b, prednisone 10 mg daily was added. RESULTS: Twenty-nine patients received treatment. Based on 3 dose limiting toxicities (DLT) (grade 4 neutropenia) in 13 patients at dose levels 1 and -1 (docetaxel 60 mg/m(2) plus satraplatin 40 mg/m(2) and docetaxel 60 mg/m(2) plus satraplatin 50 mg/m(2)) GCSF was administered with subsequent cohorts. A dose level of docetaxel 60 mg/m(2) plus satraplatin 50 mg/m(2) with GCSF was the starting dose level for phase 1b. At the highest dose in the phase 1b (docetaxel 75 mg/m(2) plus satraplatin 50 mg/m(2)) there were no DLTs. CONCLUSION: The combination of satraplatin and docetaxel is feasible in solid tumor malignancies. In advanced malignancies, the recommended phase 2 dose is docetaxel 60 mg/m(2) IV day 1 with satraplatin 40 mg/m(2)/d PO days 1-5, without G-CSF, and Docetaxel 70 mg/m(2) IV day 1 with Satraplatin 50 mg/m(2)/day PO days 1-5, with G-CSF support, repeated in 3-week cycles. For patients with CRPC the recommended phase 2 dose is docetaxel 75 mg/m(2) IV day 1 with satraplatin 50 mg/m(2)/d PO days 1--5, with G-CSF and prednisone 10 mg daily, repeated in 3-week cycles.
BACKGROUND:Satraplatin is an oral platinum with potential advantages over other platinum agents. This study investigated the combination of satraplatin and docetaxel in a phase 1 study of patients with advanced solid tumor malignancies followed by a phase 1b study in men with chemotherapy naïve metastatic castrate-resistant prostate cancer (CRPC). METHODS: In this single institution phase 1/1b study, patients received docetaxel on day 1 and satraplatin on days 1-5 of a 21-day cycle ± granulocyte colony stimulating factor (GCSF). For phase 1b, prednisone 10 mg daily was added. RESULTS: Twenty-nine patients received treatment. Based on 3 dose limiting toxicities (DLT) (grade 4 neutropenia) in 13 patients at dose levels 1 and -1 (docetaxel 60 mg/m(2) plus satraplatin 40 mg/m(2) and docetaxel 60 mg/m(2) plus satraplatin 50 mg/m(2)) GCSF was administered with subsequent cohorts. A dose level of docetaxel 60 mg/m(2) plus satraplatin 50 mg/m(2) with GCSF was the starting dose level for phase 1b. At the highest dose in the phase 1b (docetaxel 75 mg/m(2) plus satraplatin 50 mg/m(2)) there were no DLTs. CONCLUSION: The combination of satraplatin and docetaxel is feasible in solid tumor malignancies. In advanced malignancies, the recommended phase 2 dose is docetaxel 60 mg/m(2) IV day 1 with satraplatin 40 mg/m(2)/d PO days 1-5, without G-CSF, and Docetaxel 70 mg/m(2) IV day 1 with Satraplatin 50 mg/m(2)/day PO days 1-5, with G-CSF support, repeated in 3-week cycles. For patients with CRPC the recommended phase 2 dose is docetaxel 75 mg/m(2) IV day 1 with satraplatin 50 mg/m(2)/d PO days 1--5, with G-CSF and prednisone 10 mg daily, repeated in 3-week cycles.
Authors: Marc Trudeau; Gavin Stuart; Hal Hirte; Pierre Drouin; Marie Plante; Paul Bessette; Helene Dulude; David Lebwohl; Bryn Fisher; Lesley Seymour Journal: Gynecol Oncol Date: 2002-02 Impact factor: 5.482
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Authors: Eelco Fokkema; Harry J M Groen; Marco N Helder; Elisabeth G E de Vries; Coby Meijer Journal: Biochem Pharmacol Date: 2002-06-01 Impact factor: 5.858
Authors: L R Kelland; G Abel; M J McKeage; M Jones; P M Goddard; M Valenti; B A Murrer; K R Harrap Journal: Cancer Res Date: 1993-06-01 Impact factor: 12.701
Authors: Cora N Sternberg; Daniel P Petrylak; Oliver Sartor; J Alfred Witjes; Tomasz Demkow; Jean-Marc Ferrero; Jean-Christophe Eymard; Silvia Falcon; Fabio Calabrò; Nicholas James; Istvan Bodrogi; Peter Harper; Manfred Wirth; William Berry; Michael E Petrone; Thomas J McKearn; Mojtaba Noursalehi; Martine George; Marcel Rozencweig Journal: J Clin Oncol Date: 2009-10-05 Impact factor: 44.544