Nab-Paclitaxel, Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer
- Conditions
- Head and Neck Cancer
- Interventions
- Registration Number
- NCT00833261
- Lead Sponsor
- University of Texas Southwestern Medical Center
- Brief Summary
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab and cisplatin together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cetuximab and cisplatin together with radiation therapy works in treating patients with recurrent head and neck cancer.
- Detailed Description
OBJECTIVES:
Primary
* To evaluate whether treatment with cetuximab, cisplatin, and intensity-modulated radiotherapy improves the overall survival of patients with recurrent squamous cell carcinoma of the head and neck.
Secondary
* To determine the progression-free survival and local-regional progression in these patients.
* To identify and estimate the incidence rate of acute and late toxicities associated with this treatment regimen.
* To determine the pattern of disease progression in these patients.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-7. Patients also receive cisplatin IV over 60 minutes once weekly and undergo intensity-modulated radiotherapy once daily 5 days a week in weeks 2-7.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 4 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Arm: Chemotherapy with Concurrent Radiation therapy cisplatin Nab-Paclitaxel, Cetuximab, Cisplatin, and Radiation Therapy intensity-modulated radiation therapy Single Arm: Chemotherapy with Concurrent Radiation therapy Nab-Paclitaxel Nab-Paclitaxel, Cetuximab, Cisplatin, and Radiation Therapy intensity-modulated radiation therapy Single Arm: Chemotherapy with Concurrent Radiation therapy intensity-modulated radiation therapy Nab-Paclitaxel, Cetuximab, Cisplatin, and Radiation Therapy intensity-modulated radiation therapy Single Arm: Chemotherapy with Concurrent Radiation therapy cetuximab Nab-Paclitaxel, Cetuximab, Cisplatin, and Radiation Therapy intensity-modulated radiation therapy
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) 2 year from the date of enrollment The 2-year PFS was measured from the date of enrollment to the first occurrence of new metastatic lesions, objective tumor progression, or death. The combination of cisplatin and cetuximab concurrent with radiation therapy for head and neck cancer has shown to have a favorable PFS. Patients were followed until death or from 7.5 months to 63.6 months (median 25.6 months) in those alive at last evaluation.
- Secondary Outcome Measures
Name Time Method Number of Participants With Acute and Late Toxicities 6 months within the end of treatment Incidence rate of acute and late toxicities of grade 3 or higher was measured after each treatment cycle was over. The most common late toxicities defined as toxicity occurring more than 90 days after treatment included laryngeal edema and xerostomia.
Trial Locations
- Locations (4)
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Baylor Research Institute
🇺🇸Dallas, Texas, United States
University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States