Docetaxel, Cetuximab and Cisplatin Followed by Radiation, Cetuximab and Cisplatin in Head and Neck Cancer
The purpose of this study is to determine if the addition of a unique targeted agent called Cetuximab (also known as "C225" and "Erbitux") can increase the effectiveness of standard treatment with chemotherapy and radiation.
Procedure: 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 II Trial of Docetaxel, Cetuximab (C225), and Cisplatin Followed by Radiation, Cetuximab, and Cisplatin in Locally Advanced Head and Neck Cancer|
- To evaluate the objective response rate with induction with cisplatin/docetaxel/cetuximab in subjects. [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- To evaluate the toxicities, objective response rate post chemoradiotherapy, time to progression, overall survival, local and distant failure rates. [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2005|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: Single Arm study
Induction chemotherapy consists of 3 cycles of cisplatin 75 mg/m2, on day 1, docetaxel 75 mg/m2, on day 1, and cetuximab weekly days 1,8,15, repeated every 21 days (cetuximab dose is 400 mg/m2 on day 1 and 250 mg/m2 on subsequent weekly treatments). After 3 cycles of induction, patients receive standard radiation 70 Gy/200 cGy/daily, 5 days/week with concurrent weekly cisplatin 30 mg/m2 and cetuximab 250 mg/m2. After completing radiation, patients receive cetuximab weekly as maintenance therapy for 6 months (see section 5 for detailed treatment plan and dose modifications)
Docetaxel 75 mg/m2 IV over 1 hour, day 1Drug: Cisplatin
Cisplatin 75 mg/m2 IV over 1-2 hours, day 1, 1 hour following completion of cetuximab infusion.Drug: Cetuximab
Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations (days 8 and 15 of cycle 1 and days 1,8,15 of cycles 2 and 3).
Other Name: (Erbitux or C225)Procedure: Radiation Therapy
Photon energies of 1.25 to 6 MV and/or appropriate electron energies for boosting the nodes are allowed. Photon energies>6 MV may be utilized when appropriate to boost target localized centrally.
This research study involves the use of a combination of two chemotherapies, cisplatin and docetaxel, which have been known to shrink head and neck cancers and are a commonly used treatment for this type of cancer. This combination will then be followed by radiation and more chemotherapy.
The purpose of this study is to see whether this combination of chemotherapy and radiation, with the addition of Cetuximab, can improve control of disease and collect information on what side effects this combination therapy may have. In addition, biologic factors (markers) will be studied that may help to predict and treat head and neck cancer patients in the future.
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Michael Gibson, MD||University of Pittsburgh|