NCT00507429

Study of Combretastatin and Paclitaxel/Carboplatin in the Treatment of Anaplastic Thyroid Cancer

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]

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Mateon Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anaplastic Thyroid Cancer

Interventions

Type	Name	Description
DRUG	CA4P	CA4P 60mg/m squared for Days 1, 8, 15 for 6 cycles
DRUG	paclitaxel	200mg/m squared on Day 1
DRUG	carboplatin	6 AUC on Day 1 following paclitaxel

Timeline

• Start date: 2007-08-01
• Primary completion: 2011-10-01
• Completion: 2011-11-01
• First posted: 2007-07-26
• Last updated: 2014-06-09
• Results posted: 2014-06-09

Locations

41 sites across 12 countries: United States, Belarus, Bulgaria, Egypt, India, Israel, Italy, Poland, Romania, Russia, Ukraine, United Kingdom