Adjuvant Cetuximab and Chemoradiotherapy Using Either Cisplatin or Docetaxel in Treating Patients With Resected Stage III or Stage IV Squamous Cell Carcinoma or Lymphoepithelioma of the Head and Neck
RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Cisplatin and docetaxel may make the tumor cells more sensitive to radiation therapy. Combining a monoclonal antibody with chemoradiotherapy and giving them after surgery may kill any remaining tumor cells.
PURPOSE: This randomized phase II trial is studying adjuvant cetuximab given together with chemoradiotherapy using cisplatin to see how well it works compared to adjuvant cetuximab given together with chemoradiotherapy using docetaxel in treating patients with resected stage III or stage IV squamous cell carcinoma (cancer) or lymphoepithelioma of the head and neck.
Head and Neck Cancer
Procedure: adjuvant therapy
Radiation: radiation therapy
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Randomized Trial Of Surgery Followed By Chemoradiotherapy Plus Cetuximab For Advanced Squamous Cell Carcinoma Of The Head and Neck|
- Disease-free survival [ Time Frame: From randomization to 2 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: From randomization to 2 years ] [ Designated as safety issue: No ]
- Treatment tolerance [ Time Frame: From start of treatment to end of treatment ] [ Designated as safety issue: Yes ]
- Frequency of toxicity (grade 5 and acute non-hematologic grade 4) [ Time Frame: From start of treatment to last follow-up ] [ Designated as safety issue: Yes ]
- Frequency of other acute and late toxicity [ Time Frame: From start of treatment to last follow-up ] [ Designated as safety issue: Yes ]
- Local-regional control [ Time Frame: From randomization to 2 years ] [ Designated as safety issue: No ]
- Correlation of EGFR (total and phosphorylated) pMAPK, pAKT, Stat-3, KI-67, COX-2, and cyclin B1 expression with local-regional control, and overall and disease-free survival [ Time Frame: From randomization to last follow-up ] [ Designated as safety issue: No ]
|Study Start Date:||April 2004|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
Experimental: Cetuximab, cisplatin and radiation therapy (RT)
Week1: Cetuximab loading dose. Weeks 2-7: 60 Gy (2 Gy/day) plus cetuximab and cisplatin weekly.
|Biological: cetuximab Drug: cisplatin Procedure: adjuvant therapy Radiation: radiation therapy|
Experimental: Cetuximab, docetaxel and RT
Week 1: Cetuximab loading dose. Weeks 2-7: 60Gy (2Gy/day) plus cetuximab and docetaxel weekly.
|Biological: cetuximab Drug: docetaxel Procedure: adjuvant therapy Radiation: radiation therapy|
- Compare disease-free survival of patients with resected stage III or IV squamous cell carcinoma or lymphoepithelioma of the head and neck treated with adjuvant cetuximab in combination with chemoradiotherapy comprising docetaxel vs cisplatin.
- Compare the safety and efficacy of these regimens in these patients.
- Compare locoregional control and overall survival rates in patients treated with these regimens.
- Correlate epidermal growth factor receptor (total and phosphorylated), pMAPK, pAKT, Stat-3, Ki-67, cyclo-oxygenase-2, and cyclin B1 expression with outcome in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Zubrod performance status (0 vs 1), risk category (positive margins vs high risk [i.e., ≥ 2 positive nodes or extracapsular nodal extension]) and use of intensity-modulated radiotherapy (no vs yes). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive cetuximab IV over 2 hours on day 1 (week 1). Patients then receive cetuximab IV over 1 hour and cisplatin IV over 1 hour before radiotherapy on days 8, 15, 22, 29, 36, and 43 (weeks 2-7). Patients undergo radiotherapy once daily, 5 days a week, beginning on day 8 for a total of 6 weeks (weeks 2-7).
- Arm II: Patients receive cetuximab and undergo radiotherapy as in arm I. Patients also receive docetaxel IV over 30 minutes before radiotherapy on days 8, 15, 22, 29, 36, and 43 (weeks 2-7).
Treatment in both arms continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 4 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 230 patients (115 per treatment arm) will be accrued for this study within approximately 29 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00084318
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|Principal Investigator:||Paul M. Harari, MD||University of Wisconsin, Madison|
|Study Chair:||Merrill S. Kies, MD||M.D. Anderson Cancer Center|
|Study Chair:||Jeffrey N. Myers, MD, PhD, FACS||M.D. Anderson Cancer Center|