A Randomized Open-Labeled Phase II Study of Combretastatin A-4 Phosphate in Combination With Paclitaxel and Carboplatin to Evaluate the Safety and Efficacy in Subjects With Advanced Imageable Malignancies
This is a phase II study evaluating the safety and efficacy of Combretastatin A4 Phosphate
(CA4P) combined with carboplatin and paclitaxel. Treatment is for a maximum of 6
consecutive 21-day cycles. Patients are randomized onto one of two CA4P dosing arms (45 or
63 mg/m2). CA4P is administered on days 1, 8 and 15 of each cycle. Carboplatin and
paclitaxel (AUC 6 and 200 mg/m2, respectively) are administered on day 2 of each cycle. At
least 2 DCE-MRI scans will be performed to evaluate the change in tumor blood flow following
treatment with CA4P.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess safety of the CA4P-paclitaxel-carboplatin combination in advanced imageable malignancies
From first administration of study drug through approximately 30 days following last dose of study drug
Yes
United States: Food and Drug Administration
CA4P-212
NCT00113438
March 2005
February 2007
Name | Location |
---|---|
Huntsman Cancer Institute | Salt Lake City, Utah 84112 |