A Phase I/II Trial of Abraxane in Combination With Carboplatin, Erbitux and Intensity Modulated Radiation Therapy (IMRT)for Treatment of Locally Advanced Squamous Cancer of the Head and Neck
- Participants will receive radiation therapy, typically done Monday through Friday for
about seven weeks (participants will sign a separate consent form with the radiation
oncologist that will outline what to expect from this treatment).
- On the first week of the study (in the week prior to the start of radiation)
participants will receive one dose of Erbitux only. After that, they will receive all
three drugs (Erbitux, Abraxane and Carboplatin) weekly during the 7 weeks of radiation.
These drugs are given intravenously. Each participant will receive the same dose of
Erbitux and carboplatin. The dose of Abraxane will depend upon when the participant is
enrolled in the study and if the maximum tolerated dose has been established.
- Participants will be examined every week during the treatment. A physical exam will be
performed along with questions about general health and specific questions about any
problems the participant is experiencing.
- Blood tests will be done every week during treatment and include chemistry and
- Participants will be asked to return to the clinic within 8 to 10 weeks of finishing
the treatment. The following exams and procedures will be performed during this time:
physical exam; blood tests; imaging of the tumor; imaging of the chest and; neck
surgery (if the study doctors think that the participant may benefit from surgery to
remove lymph nodes in the neck).
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase I: To identify the maximally tolerated dose of Abraxane given with carboplatin and Erbitux plus concurrent IMRT.
Roy B. Tishler, MD
Dana-Farber Cancer Institute
United States: Institutional Review Board