A phase II trial of docetaxel and erlotinib as first-line therapy for elderly patients with androgen-independent prostate cancer

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A phase II trial of docetaxel and erlotinib as first-line therapy for elderly patients with androgen-independent prostate cancer

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dc.contributor.author Gross, Mitchell en_US
dc.contributor.author Higano, Celestia en_US
dc.contributor.author Pantuck, Allan en_US
dc.contributor.author Castellanos, Olga en_US
dc.contributor.author Green, Erica en_US
dc.contributor.author Nguyen, Koo en_US
dc.contributor.author Agus, David B. en_US
dc.date.accessioned 2010-04-21T15:54:05Z
dc.date.available 2010-04-21T15:54:05Z
dc.date.issued 2007 en_US
dc.identifier.citation Gross M, Higano C, Pantuck A, et al. A phase II trial of docetaxel and erlotinib as first-line therapy for elderly patients with androgen-independent prostate cancer. BMC Cancer. 2007;7(1):142. en_US
dc.identifier.other 10.1186/1471-2407-7-142 en_US
dc.identifier.uri http://www.biomedcentral.com/1471-2407/7/142 en_US
dc.identifier.uri http://hdl.handle.net/1773/15759
dc.description.abstract Background: Docetaxel is the standard first-line agent for the treatment of androgen-independent prostate cancer (AIPC). The combination of docetaxel with molecularly targeted therapies may offer the potential to increase the efficacy and decrease the toxicity of cytotoxic chemotherapy for prostate cancer. Previous studies demonstrate activation of the human epidermal growth factor receptor (EGFR) in prostate cancer. Erlotinib is a specific inhibitor of the tyrosine-kinase activity of EGFR. The goal of this study is to determine the anti-cancer activity docetaxel combined with erlotinib for the treatment of elderly subjects with AIPC. Methods: This is a multi-institutional Phase II study in patients with histologically confirmed adenocarcinoma of the prostate and age [greater than or equal to] 65 years. Patients were requred to have progressive disease despite androgen-deprivation therapy as determined by: (1) measurable lesions on cross-sectional imaging; (2) metastatic disease by radionucleotide bone imaging; or (3) elevated prostate specific antigen (PSA). Treatment cycles consisted of docetaxel 60 mg/m2 IV on day 1 and erlotinib 150 mg PO days 1-21. Patients with responding or stable disease after 9 cycles were eligible to continue on erlotinib alone as maintenance therapy. Results: Characteristics of 22 patients enrolled included: median age 73.5 years (range, 65-80); median Karnofsky Performance Status 90 (range 70-100); median hemoglobin 12.1 g/dl (range, 10.0-14.3); median PSA 218.3 ng/ml (range, 9-5754). A median of 6 treatment cycles were delivered per patient (range 1-17). No objective responses were observed in 8 patients with measurable lesions (0%, 95% CI 0-31%). Bone scan improvement and PSA decline was seen in 1 patient (5%, 95% CI 0.1-25%). Five of 22 patients experienced [greater than or equal to] 50% decline in PSA (23%, 95% CI 8-45%). Hematologic toxicity included grade 3 neutropenia in 9 patients and neutropenic fever in 2 patients. Common non-hematologic toxicities ([greater than or equal to] grade 3) included fatigue, anorexia, and diarrhea. Conclusion: Docetaxel/erlotinib can be delivered safely in elderly patients with AIPC. Anti-cancer disease activity appears generally comparable to docetaxel when used as monotherapy. Hematologic and nonhematologic toxicity may be increased over docetaxel monotherapy. Prospective randomized studies would be required to determine if the toxicity of docetaxel and erlotinib justifies its use in this setting. en_US
dc.description.sponsorship This study was supported by NIH Prostate SPORE P50 CA92131 to DBA. Phase One Foundation to MEG and DBA. en_US
dc.language.iso en_US en_US
dc.title A phase II trial of docetaxel and erlotinib as first-line therapy for elderly patients with androgen-independent prostate cancer en_US
dc.type Article en_US


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