Evaluation of Cetuximab (ERBITUX) and Concurrent Carboplatin, Paclitaxel & Radiotherapy in the Management of Patients With Advanced Locoregional Squamous Cell Carcinomas of the Head and Neck (GCC 0442)
The purpose of this study is to evaluate the response of the tumor to the treatment regimen that will be used in this study. This study will also test the safety of cetuximab (C225), given with chemotherapy and radiation therapy. We also want to see what effects (good and bad) cetuximab, chemotherapy, and radiation therapy have head & neck cancer.
C225 has been designed to stop the growth of the tumor by blocking certain chemical pathways that lead to tumor cell growth. In prior studies with head & neck cancer patients, C225 has delayed tumor growth and provided relief of symptoms in some patients.
Cancer of Head and Neck
Drug: Erbitux, Paclitaxel & Carboplatin
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Evaluation of Cetuximab (ERBITUX) and Concurrent Carboplatin, Paclitaxel & Radiotherapy in the Management of Patients With Advanced Locoregional Squamous Cell Carcinomas of the Head and Neck|
- The Primary Endpoint is the Local Regional Control Rate Assessed 3 Months Post Completion of Radiation Therapy. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]The local regional control rate was assessed 3 months post completion of radiation therapy based on either MRI or CT and clinical exam.
- Local Regional Control at 2 Years [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Overall Survival and Disease-free Survival [ Time Frame: 3 years (overall) 2 years disease-free ] [ Designated as safety issue: Yes ]
- Pathological Response to Cetuximab [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Adding CTX to weekly PC and daily RT. CBC and Chemistry panel blood testing
- Percentage of Participants With Grade 3 Toxicities of Cetuximab [ Time Frame: 9 weeks ] [ Designated as safety issue: Yes ]
One of the more serious side effects of cetuximab therapy is the incidence of acne-like rash. This rash rarely leads to dose reductions or termination of therapy. It is generally reversible.
Further severe infusion reactions include but are not limited to: fevers, chills, rigors, urticaria, pruritis, rash, hypotension, N/V, HA, bronchospasm, dyspnea, wheezing, angioedema, dizziness, anaphylaxis, and cardiac arrest. Therefore, pretreatment with diphenhydramine 30-60 min. before administration is standard of care. Other common side effects include photosensitivity, hypomagnesemia due to magnesium wasting, and less commonly pulmonary and cardiac toxicity.
- Clinical Complete Response Rate of This Regimen in the Population [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]What is the the complete response (CR) rate at the completion of therapy.
|Study Start Date:||December 2004|
|Study Completion Date:||May 2012|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Experimental: Cetuximab comparison for Head and Neck Cancer
To report the mature data of a prospective Phase II trial designed to evaluate the efficacy of an epidermal growth factor receptor inhibitor cetuximab (CTX) added to the concurrent therapy of weekly paclitaxel/carboplatin (PC) and daily radiation therapy (RT).
Both chemotherapy and radiation will be given on a weekly basis (see interventions for details).
Drug: Erbitux, Paclitaxel & Carboplatin
Paclitaxel, 40 mg/m2/week,
1-hour infusion (weeks 2-9.Paclitaxel will be administered on a weekly schedule at a dose of 40mg/m2 IV by 1-hour infusion prior to cetuximab dose.
Cetuximab: 400 mg/m2 IV (initial dose) week 1 then 250 mg/m2 IV weekly for 8 weeks weeks 2-9). Cetuximab will be administered 400mg/m2 IV on Day 1, then the first 250 mg/m2 IV dose will be given on day 8 (week 2) prior to carboplatin dose.
Carboplatin, AUC=2/week as a 30 minute infusion after cetuximab infusion (weeks 2-9)Carboplatin will be administered at a dose of AUC = 2/week IV bolus each week and will be administered prior to head and neck irradiation dose. (Carboplatin: AUC=2/week x 8 weeks (weeks 2-9)
Other Name: Taxol, ErbituxRadiation: Radiation
XRT=Radiotherapy 1.8 Gy radiation/day, 5 days a week for a total of 70.2 Gy.(weeks 2-9) - IMRT is allowed
Primary Objective- To evaluate whether the addition of Cetuximab (C225) in combination with chemotherapy and radiation can cause an enhanced anti-tumor effect resulting in improving local regional control of patients with locally advanced, unresectable squamous cell carcinoma of head and neck. (SCCHN).
OVERVIEW OF STUDY DESIGN Open label, non-randomized, single arm trial.
P = Paclitaxel will be administered on a weekly schedule at a dose of 40mg/m2 IV by 1-hour infusion prior to cetuximab dose. This will be administered for a total of 8 weeks (from weeks 2-9)
C225 = Cetuximab: 400 mg/m2 IV will be given as the initial OR loading dose in week 1 and then 250 mg/m2 IV weekly will be given for 8 weeks (weeks 2-9).
C = Carboplatin will be given at a dose of AUC=2/week - will be administered as a 30 minute infusion after cetuximab infusion (weeks 2-9)
RT = Radiation therapy will be delivered at 1.8 Gy fraction/day, 5 days a week for a total of 70.2 Gy. RT will be given from weeks 2-9.
Note: Sequence of administration will be paclitaxel followed by cetuximab followed by carboplatin followed by XRT.
Approximately 60 patients from MSGCC/BVAMC will participate in this study. Prior to entering the study the doctor will examine the patient and order blood tests ( which will be done by blood draw, approximately 2 tablespoons) and tests to measure the patients disease (scans). The patient will also be evaluated by a dietician who will follow the patient throughout the course of the therapy to help the patient meet his/her nutritional needs
|United States, Maryland|
|University of Maryland & Baltimore VA medical centre|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Mohan Suntharalingam, M.D||University of Maryland|