Abraxane in Combination With Carboplatin, Erbitux and IMRT for Locally Advanced Squamous Cancer of the Head and Neck
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.
Squamous Cell Carcinoma of the Head and Neck
Basaloid Squamous Cell Carcinoma
Adenosquamous Cell Carcinoma
Radiation: Intensity Modulated Radiation Therapy
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Phase I: To identify the maximally tolerated dose of Abraxane given with carboplatin and Erbitux plus concurrent IMRT. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Phase II: To evaluate the efficacy by evaluating 2-year-disease-free survival. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To evaluate the safety and tolerability of the combination of Abraxane, carboplatin and Erbitux. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- To estimate the overall response rate to ACE-RT. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To estimate 2-year overall survival. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To evaluate functional outcome at 2 years with respect to speech, swallowing and overall quality of life. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||November 2007|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Dose will vary depending upon when enrolled on trial. Given as an infusion.Drug: Erbitux
One dose is given prior to the start of radiation, then weekly by infusion.Drug: Carboplatin
Given weekly as an infusion.Radiation: Intensity Modulated Radiation Therapy
Monday through Friday for about seven weeks.
- 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 hematology tests.
- 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).