Trials / Completed
CompletedNCT00095927
Randomized Amifostine For SCCHN
Phase II, Randomized Study of Concomitant Chemoradiation Using Weekly Carboplatinum/Paclitaxel With (Arm A) or Without (Arm B) Daily Subcutaneous Amifostine in Patients With Newly Diagnosed Locally Advanced Squamous Cell Cancer of the Head and Neck
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 58 (actual)
- Sponsor
- Dana-Farber Cancer Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This research study is studying a drug called Amifostine as a treatment for squamous cell carcinoma in the head and/or neck area.
Detailed description
Amifostine is a drug that is used to treat moderate to severe xerostomia (dry mouth) for those who receive radiation therapy for head and neck cancer. It was approved by the FDA for use intravenously. This study plans to examine the effects of xerostomia when Amifostine is used subcutaneously (by injection). Amifostine has been seen to be effective when used to combat the effects of dry mouth, but also has some side effects which are listed later in this consent form. The purpose of this study is to examine the effectiveness of twice a day radiation therapy given with chemotherapy consisting of carboplatin and paclitaxel (Taxo 1). This study will examine the effectiveness of adding Amifostine in the hopes of reducing the side effects of radiation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Amifostine | Given subcutaneously |
| DRUG | Carboplatin | Given IV |
| DRUG | Paclitaxel | Given IV |
| RADIATION | radiation | Given once daily for 4 weeks and then twice daily for 2 weeks. |
Timeline
- Start date
- 2003-05-01
- Primary completion
- 2007-06-01
- Completion
- 2008-06-01
- First posted
- 2004-11-09
- Last updated
- 2017-01-04
Locations
9 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00095927. Inclusion in this directory is not an endorsement.