drugset / Trial / NCT00113438
Safety and Effectiveness of Combretastatin A-4 Phosphate Combined With Chemotherapy in Advanced Solid Tumors
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a study evaluating the safety and effectiveness of Combretastatin A4 Phosphate (CA4P) combined with the chemotherapy drugs, carboplatin and paclitaxel. The full treatment and observation time should be about 5 months. During this time the patient should receive 18 CA4P infusions and 6 carboplatin followed by paclitaxel treatments. Patients will be randomized into one of two CA4P dose-level groups in order to recommend a preferred dose-level for future studies. At least 2 dynamic contrast enhanced-magnetic resonance imaging (DCE-MRI) scans will be conducted to monitor the blood flow through the tumor before and after treatment with CA4P.
Timeline
- Start
- 2005-03
- Primary completion
- 2007-02
- Completion
- 2007-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | fosbretabulin | Small molecule | 45 mg/m2 | Intravenous |
| Subject | fosbretabulin | Small molecule | 60 mg/m2 | Intravenous |
| Background | Carboplatin | Small molecule | — | — |
| Background | Paclitaxel | Small molecule | 200 mg/m2 | — |