drugset / Trial / NCT00570674
Abraxane in Combination With Carboplatin, Erbitux and IMRT for Locally Advanced Squamous Cancer of the Head and Neck
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purpose of the Phase I part of this research study is to determine the safest and most effective dose of Abraxane when given in combination with carboplatin and Erbitux during radiation therapy for head and neck cancer. The purpose of the Phase II part of this study is to determine the effects of the treatment on head and neck cancers, as well as to further study the safety of this treatment.
Timeline
- Start
- 2007-11
- Primary completion
- 2013-10
- Completion
- 2013-10
Outcome
Outcome not reported
Stopped: “The study did not continue to phase II due to the importance of HPV status as a prognostic factor to guide treatment decisions.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abraxane | Small molecule | 20 mg/m2 | Intravenous |
| Subject | Abraxane | Small molecule | 30 mg/m2 | Intravenous |
| Subject | Abraxane | Small molecule | 40 mg/m2 | Intravenous |
| Subject | Abraxane | Small molecule | 50 mg/m2 | Intravenous |
| Subject | Carboplatin | Small molecule | 1.5 unknown | Intravenous |
| Subject | Cetuximab | Monoclonal antibody | 250 mg/m2 | Intravenous |