NCT00409565

A Phase II Trial of Cetuximab and Bevacizumab in Patients With Recurrent or Metastatic Head and Neck Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years – 98 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if the combination of two new drugs, cetuximab (Erbitux) and bevacizumab (Avastin) can increase the effectiveness of treatment for head and neck cancer. Cetuximab has recently been approved by the FDA for head and neck cancer (that is locally or regionally advanced) when used in combination with radiation therapy. Cetuximab is also approved by the FDA for the treatment of colorectal cancer

Detailed description

Approximately 40,000 new cases of head and neck cancer are diagnosed annually in the United States 1. Squamous cell carcinomas account for more than 90% of head and neck cancer cases. Patients with squamous cell carcinoma of the head and neck (HNSCC) usually present with locoregionally advanced disease. Initial presentation with distant metastasis may occur in about 10% of all patients. However, recurrence of disease either in local or distant sites after potentially curative treatment with surgery, radiation, and/or chemotherapy occurs in more than 50% of patients. Therefore, the majority of patients with HNSCC develop recurrent or metastatic disease during the course of their illness. These patients have a dismal prognosis with a median survival of 6-9 months 2-4. Active single agents in head and neck squamous cell carcinoma include methotrexate, bleomycin, cisplatin, carboplatin, 5-FU, paclitaxel, docetaxel, and CPT-11. A small randomized study showed that cisplatin monotherapy prolongs survival compared with best supportive care 5. Response rates for single agents range between 10-40% 2, 4, 6, 7. Combination chemotherapy with platinum agents, in spite of achieving higher response rates (about 30% in phase III trials), has not been shown to produce a survival benefit compared to single agents in randomized comparisons in recurrent/metastatic head and neck cancer 2, 4.

Conditions

• Head and Neck Cancer
• Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Cetuximab	* Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY * Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations
DRUG	Bevacizumab	Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given

Timeline

• Start date: 2006-09-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2006-12-11
• Last updated: 2017-10-20
• Results posted: 2016-07-12

Locations

4 sites across 1 country: United States