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Brief Title: Study of Combretastatin and Paclitaxel/Carboplatin in the Treatment of Anaplastic Thyroid Cancer
Official Title: A Phase II/III Study to Evaluate the Safety and Efficacy of Combretastatin A-4 Phosphate in Combination With Paclitaxel and Carboplatin in Comparison With Paclitaxel and Carboplatin Against Anaplastic Thyroid Carcinoma [FACT]
Study ID: NCT00507429
Brief Summary: The purpose of the study is to determine the safety and efficacy of combretastatin combined with paclitaxel and carboplatin in the treatment of anaplastic thyroid cancer (ATC).
Detailed Description: Anaplastic thyroid carcinoma (ATC) is a high-grade neoplasm, characterized by an aggressive clinical course with brief survival, and refractoriness to currently available local and systemic modalities of treatment. There is no standard therapy for ATC, and no randomized comparative trials have been known to be conducted in this disease. One potential strategy is to combine the anti-tumor activity of the vascular disrupting agent combretastatin with conventional cytotoxic agents. This study will compare the overall survival of ATC patients treated with the triplet combination of combretastatin, paclitaxel, and carboplatin compared with the doublet treatment of paclitaxel and carboplatin.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
Yale University, School of Medicine, New Haven, Connecticut, United States
Winship Cancer Institute, Emory University, Atlanta, Georgia, United States
Sidney Kimmel Comprehensive Cancer Care Center at John Hopkins, Baltimore, Maryland, United States
University of Minnesota Otolaryngology Department, Minneapolis, Minnesota, United States
Ireland Cancer Center/Division od Hematology, Cleveland, Ohio, United States
Oregon Health and Science University, Portland, Oregon, United States
University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States
West Virginia University, Morgantown, West Virginia, United States
Belarus National Medical University, Minsk, , Belarus
Regional Oncology Dispensary with Inpatient Sector, Plodiv, , Bulgaria
Specialized Hospital for Active Treatment of Oncology, Sofia, , Bulgaria
Universtiy Multiprofile Hospital, ISUI, Clinic of Oncotherapy, Sofia, , Bulgaria
University Hospital, Cairo, Cairo, , Egypt
Mediciti Hospital, Hyderabaad, Andhra Pradesh, India
All India Institute of Medical Sciences, New Delhi, Delhi, India
Apollo Cancer Institute, New Delhi, Delhi, India
Kidwai Memorial Hospital, Bangalore, Karnataka, India
Shirdi Sai Baba Cancer Hospital, Manipal, Karnataka, India
Tata Memorial Centre, Mumbai, Maharashtra, India
Ruby Hall Clinic, Pune, Maharashtra, India
Christian Medial College, Vellore, Tamil Nadu, India
Telaviv Sourasky Medical Center, Head and Neck Service Division of Oncology, Tel-Aviv, , Israel
Lo Studio E la Cura, Milano, , Italy
INT Napoli Fondazione Pascale, Napoli, , Italy
Istituto Oncologico Veneto (IOV) - IRCCS, Padova, , Italy
Azienda Ospedaliero - Universitaria Pisana, Pisa, , Italy
Zaklad Medyczny Nuklearnej i Endykrynologii, Gliwice, , Poland
Klinika Nowotworow Glowy i Szyji, Warszawa, , Poland
Institutul Oncologic, Cluj-Napoca, , Romania
SC Meditech SRL, Craiova, , Romania
Centr of Medical Oncology, Iasi, , Romania
Clinical County Hospital Sibiu, Sibiu, , Romania
Emergency Clinical County Hospital "Sf. loan cel Nou", Suceava, , Romania
City Clinical Oncology Dispensary, Saint Petersburg, , Russian Federation
Ukrainian Academy of Medical Science, Lomonosova 33/43, Kiev, Ukraine
Regional Clinical Oncology Dispensary, Lvov, , Ukraine
Beatson Oncology Centre, Gartnavel General Hospital, Glasgow, Scotland, United Kingdom
Royal Marsden Hospital and Institute of Cancer Research, London, , United Kingdom
Southampton Hospital Oncology Centre, Southampton, , United Kingdom
Name: Julie A. Sosa, MD, FACS
Affiliation: Yale University School of Medicine, New Haven, CT
Role: PRINCIPAL_INVESTIGATOR