11-20-2007, 10:41 PM
Summary This phase II trial was initiated to assess the efficacy and safety of oral vorinostat (Zolinza™, suberoylanilide hydroxamic
acid, SAHA) in patients with recurrent and/or metastatic head and neck cancer. Eligible patients must have recurrent and/or
metastatic head and neck cancer unresponsive to or intolerant of conventional chemotherapy. Patients must have measurable
disease, adequate hematologic, hepatic, and renal function, and be able to swallow capsules. Four or more weeks must have
elapsed since prior chemotherapy, radiation therapy, major surgery or investigational anticancer therapy, and patients must
have recovered from prior toxicities. Study endpoints included response rate, duration of stable disease and progression-free
survival. Thirteen patients were enrolled (9 males); 1 withdrew consent prior to starting therapy. Twelve patients received
oral vorinostat 400 mg once daily and were evaluable for response. The median age was 54 years (range 40–82). All patients
had received prior chemotherapy (including 10 with platinum- or taxane-based combination therapy), and 9 had prior radiation
therapy. No confirmed partial or complete responses were observed. One unconfirmed partial response was seen. Three patients
had stable disease ranging from 9 to 26 weeks. Nine patients discontinued due to progressive disease, two withdrew consent,
and one discontinued therapy for grade 3 anorexia. Grades 3–4 drug-related toxicities included thrombocytopenia (n = 3), anorexia (n = 2), and dehydration (n = 2). Oral vorinostat 400 mg qd was generally well tolerated but did not demonstrate efficacy as defined by tumor response
in this small group of heavily pre-treated patients.
Content Type Journal ArticleCategory PHASE II STUDIESDOI 10.1007/s10637-007-9075-2Authors
George R. Blumenschein, The University of Texas M.D. Anderson Cancer Center Department of Thoracic and Head and Neck Medical Oncology 1515 Holcombe Boulevard Houston TX 77030 USAMerrill S. Kies, The University of Texas M.D. Anderson Cancer Center Department of Thoracic and Head and Neck Medical Oncology 1515 Holcombe Boulevard Houston TX 77030 USAVassiliki A. Papadimitrakopoulou, The University of Texas M.D. Anderson Cancer Center Department of Thoracic and Head and Neck Medical Oncology 1515 Holcombe Boulevard Houston TX 77030 USACharles Lu, The University of Texas M.D. Anderson Cancer Center Department of Thoracic and Head and Neck Medical Oncology 1515 Holcombe Boulevard Houston TX 77030 USAAshok J. Kumar, The University of Texas M.D. Anderson Cancer Center Department of Thoracic and Head and Neck Medical Oncology 1515 Holcombe Boulevard Houston TX 77030 USAJustin L. Ricker, Merck Research Laboratories Upper Gwynedd PA USAJudy H. Chiao, Merck Research Laboratories Upper Gwynedd PA USACong Chen, Merck Research Laboratories Upper Gwynedd PA USAStanley R. Frankel, Merck Research Laboratories Upper Gwynedd PA USA
Journal Investigational New DrugsOnline ISSN 1573-0646Print ISSN 0167-6997 (Source: Investigational New Drugs)
Posted on Thu, 25 Oct 2007 15:06:32 +0100 at http://www.springerlink.com/content/jn239j6306784723/
Author: Investigational New Drugs
Comments: http://www.medworm.com/rss/comments.php?id=981884
acid, SAHA) in patients with recurrent and/or metastatic head and neck cancer. Eligible patients must have recurrent and/or
metastatic head and neck cancer unresponsive to or intolerant of conventional chemotherapy. Patients must have measurable
disease, adequate hematologic, hepatic, and renal function, and be able to swallow capsules. Four or more weeks must have
elapsed since prior chemotherapy, radiation therapy, major surgery or investigational anticancer therapy, and patients must
have recovered from prior toxicities. Study endpoints included response rate, duration of stable disease and progression-free
survival. Thirteen patients were enrolled (9 males); 1 withdrew consent prior to starting therapy. Twelve patients received
oral vorinostat 400 mg once daily and were evaluable for response. The median age was 54 years (range 40–82). All patients
had received prior chemotherapy (including 10 with platinum- or taxane-based combination therapy), and 9 had prior radiation
therapy. No confirmed partial or complete responses were observed. One unconfirmed partial response was seen. Three patients
had stable disease ranging from 9 to 26 weeks. Nine patients discontinued due to progressive disease, two withdrew consent,
and one discontinued therapy for grade 3 anorexia. Grades 3–4 drug-related toxicities included thrombocytopenia (n = 3), anorexia (n = 2), and dehydration (n = 2). Oral vorinostat 400 mg qd was generally well tolerated but did not demonstrate efficacy as defined by tumor response
in this small group of heavily pre-treated patients.
Content Type Journal ArticleCategory PHASE II STUDIESDOI 10.1007/s10637-007-9075-2Authors
George R. Blumenschein, The University of Texas M.D. Anderson Cancer Center Department of Thoracic and Head and Neck Medical Oncology 1515 Holcombe Boulevard Houston TX 77030 USAMerrill S. Kies, The University of Texas M.D. Anderson Cancer Center Department of Thoracic and Head and Neck Medical Oncology 1515 Holcombe Boulevard Houston TX 77030 USAVassiliki A. Papadimitrakopoulou, The University of Texas M.D. Anderson Cancer Center Department of Thoracic and Head and Neck Medical Oncology 1515 Holcombe Boulevard Houston TX 77030 USACharles Lu, The University of Texas M.D. Anderson Cancer Center Department of Thoracic and Head and Neck Medical Oncology 1515 Holcombe Boulevard Houston TX 77030 USAAshok J. Kumar, The University of Texas M.D. Anderson Cancer Center Department of Thoracic and Head and Neck Medical Oncology 1515 Holcombe Boulevard Houston TX 77030 USAJustin L. Ricker, Merck Research Laboratories Upper Gwynedd PA USAJudy H. Chiao, Merck Research Laboratories Upper Gwynedd PA USACong Chen, Merck Research Laboratories Upper Gwynedd PA USAStanley R. Frankel, Merck Research Laboratories Upper Gwynedd PA USA
Journal Investigational New DrugsOnline ISSN 1573-0646Print ISSN 0167-6997 (Source: Investigational New Drugs)
Posted on Thu, 25 Oct 2007 15:06:32 +0100 at http://www.springerlink.com/content/jn239j6306784723/
Author: Investigational New Drugs
Comments: http://www.medworm.com/rss/comments.php?id=981884