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Phase I trial of docetaxel and thalidomide: a regimen based on metronomic therapeutic principles Journal Investigational New Drugs Publisher Springer Netherlands ISSN 0167-6997 (Print) 1573-0646 (Online) Issue Volume 26, Number 4 / August, 2008 Category PHASE I STUDIES DOI 10.1007/s10637-008-9137-0 Pages 355-362 Subject Collection Medicine SpringerLink Date Saturday, May 10, 2008	Add to marked items Add to shopping cart Add to saved items Permissions & Reprints Recommend this article

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PHASE I STUDIES

Phase I trial of docetaxel and thalidomide: a regimen based on metronomic therapeutic principles
Sharon L. Sanborn¹, Matthew M. Cooney¹ , Afshin Dowlati¹, Joanna M. Brell¹, Smitha Krishnamurthi¹, Joseph Gibbons¹, Joseph A. Bokar¹, Charles Nock¹, Anne Ness¹ and Scot C. Remick²

(1)	Division of Hematology and Oncology, University Hospitals Case Medical Center, Case Comprehensive Cancer Center, 11100 Euclid Avenue, Lakeside 1200, Cleveland, OH 44106, USA

(2)	Mary Babb Randolph Cancer Center, West Virginia University, 1801 Health Sciences South, P.O. Box 9300, Morgantown, WV 26506, USA

Received: 25 February 2008 Accepted: 8 April 2008 Published online: 10 May 2008
Summary Purpose: Pre-clinical models have demonstrated the benefit of metronomic schedules of cytotoxic chemotherapy combined with anti-angiogenic compounds. This trial was undertaken to determine the toxicity of a low dose regimen using docetaxel and thalidomide. Patients and Methods: Patients with advanced solid tumors were enrolled. Thalidomide 100mg twice daily was given with escalating doses of docetaxel from 10 to 30mg/m²/week. One cycle consisted of 12 consecutive weeks of therapy. The maximal tolerated dose (MTD) was defined as the dose of thalidomide along with docetaxel that caused ≤grade 1 non-hematologic or ≤grade 2 hematologic toxicity for cycle one. Results: Twenty-six patients were enrolled. Dose-limiting toxicities (DLTs) were bradycardia, fatigue, fever, hyperbilirubinemia, leukopenia, myocardial infarction, and neutropenia. Prolonged freedom from disease progression was observed in 44.4% of the evaluable patients. Conclusions: This anti-angiogenic regimen was well tolerated and demonstrated clinical benefit. The recommended phase II dosing schedule is thalidomide 100mg twice daily with docetaxel 25mg/m²/week.
Keywords Metronomic - Docetaxel - Thalidomide - Angiogenesis - Phase I

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Matthew M. Cooney Email: matthew.cooney@UHhospitals.org