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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
CA4P 60mg/m squared for Days 1, 8, 15 for 6 cycles
200mg/m squared on Day 1
6 AUC on Day 1 following paclitaxel
Overall Survival
Time frame: From randomization to date last known alive
To Determine Progression Free Survival
Time frame: from randomization through end of study visit
To Determine Percentage of 1 Year Survival
Time frame: from randomization through end of study visit
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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
...and 31 more locations