Phase I/II study on docetaxel, gemcitabine and prednisone in castrate refractory metastatic prostate cancer. Cancer chemotherapy and pharmacology [Cancer Chemother Pharmacol] Journal article | | Title | Phase I/II study on docetaxel, gemcitabine and prednisone in castrate refractory metastatic prostate cancer. | | Author(s) | Buch-Hansen TZ, Bentzen L, Hansen S, Hoeyer M, Jensen NV, Saxe C, Sengeloev L | | Institution | Department of Oncology, Herlev University Hospital, Herlev Ringvej 75, 2730, Herlev, Denmark, trzebu01@heh.regionh.dk. | | Source | Cancer Chemother Pharmacol 2009 Oct 31. | | Abstract | PURPOSE: We assessed the efficacy and toxicity of a fixed dose of docetaxel and prednisone, combined with escalating doses of gemcitabine (DGP). The primary endpoint was PSA response.
METHODS: Fifteen patients were enrolled in the phase I and 50 patients entered the phase II. Patients were given DGP, maximum of eight courses, until progression or unacceptable toxicity. Docetaxel 75 mg/m(2) was administered intravenously day 1, gemcitabine was given day 1 and 8 in doses increasing from 600 to 1,000 mg/m(2) every third week. Patients had castrate refractory metastatic prostate cancer (CRMPC), adequate function of liver, kidney and bone marrow; ECOG performance status </=2 and were chemotherapy-naïve.
RESULTS: Median age was 64 range (49-77). Twenty-one (42%) were PS 0, 26 (52%) were PS 1 and 3 (6%) were PS 2. The median pre-treatment PSA was 448 (12-4.580). No dose limiting toxicity was observed even with the highest dose level in the phase I part of the study. In the phase II part, PSA response was observed in 37 (74%) patients. Twenty-four (48%) patients had measurable disease; 12 (50%) had partial remission, 5 (21%) had stable disease, 7 (29%) were not evaluable. Time to progression (TTP) was 7.9 months and overall survival (OS) was 13.9 months. Thirty-seven patients (74%) developed neutropenia, non-haematological toxicity was modest.
CONCLUSIONS: The PSA response rate was promising and the toxicity of DGP was manageable; however OS was comparable to results of treatment with single agent docetaxel. | | Language | ENG | | Pub Type(s) | JOURNAL ARTICLE
| | PubMed ID | 19882157 |
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