A randomized phase II/III trial of a tumor vascular disrupting agent fosbretabulin tromethamine (CA4P) with carboplatin (C) and paclitaxel (P) in anaplastic thyroid cancer (ATC): Final survival analysis for the FACT trial
| Autor: | Charles Lu, S. Lu, Shanthi Marur, S. M. Karandikar, R. Ben-Yosef, Lisa Licitra, Scot C. Remick, J. Balkissoon, H. Koussis, Barbara J. Gitlitz, Ann Wild Gramza, Fadlo R. Khuri, Barbara Jarzab, Frank G. Ondrey, Rossella Elisei, Julie Ann Sosa, Bryan R. Haugen, Chandrasekhar Bal |
|---|---|
| Rok vydání: | 2011 |
| Předmět: |
Oncology
PHASE II/III TRIAL Cancer Research medicine.medical_specialty Combination therapy Fosbretabulin Tromethamine business.industry medicine.disease Carboplatin Surgery law.invention chemistry.chemical_compound chemistry Paclitaxel Randomized controlled trial law Internal medicine medicine Anaplastic thyroid cancer business Survival analysis |
| Zdroj: | Journal of Clinical Oncology. 29:5502-5502 |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.2011.29.15_suppl.5502 |
| Popis: | 5502 Background: CA4P, a vascular disrupting agent (VDA), has shown clinical activity as monotherapy in patients with ATC. Results include a durable CR in a phase I trial and a median survival of 4.7 months with 34% of patients alive at 6 months and 23% of patients alive at 1-year in a Phase 2 trial. Interim results previously presented from this phase II/III study evaluating CA4P in combination with carboplatin (C) + paclitaxel (P) in patients with ATC suggested a survival benefit with the combination therapy. Final survival and safety data are now available. Methods: This is a multicenter, open-label, 2:1 randomized trial for patients with histologically confirmed ATC. 80 out of 180 planned patients were randomized to receive up to 6 cycles of C + P with CA4P (CA4P Arm) or without CA4P (Control Arm). The targeted sample size of 180 patients was not reached due to slow enrollment. After 6 cycles of therapy, patients on the CA4P Arm without progression could continue to receive CA4P until disease progress... |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|