Clinical trial NCT00301028
Conditions: Head and Neck Cancer
Keywords: stage IV squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the nasopharynx stage IV squamous cell carcinoma of the lip and oral cavity
Sponsor: M.D. Anderson Cancer Center
Start date: 2006-04-01; Completion date: 2011-09-01
Enrollment: 48 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carboplatin, paclitaxel, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Giving cetuximab together with combination chemotherapy and radiation therapy, with or without cisplatin, may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab together with carboplatin and paclitaxel followed by radiation therapy, with or without cisplatin, works in treating patients with metastatic head and neck cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine the increase in clinical/radiographic complete response rate in patients with previously untreated metastatic squamous cell carcinoma of the head and neck treated with induction therapy comprising cetuximab, carboplatin, and paclitaxel.
* Determine the toxic effects of this regimen in these patients.

Secondary

* Determine the pattern of tumor recurrence in patients treated with this regimen.
* Determine the quality of life of patients treated with this regimen.
* Determine the duration of response, time to progression, and survival of patients treated with this regimen.
* Correlate effects of this regimen with biomarkers of response and predictors of long-term outcome in these patients.

OUTLINE: This is a nonrandomized, open-label study.

Patients receive induction therapy comprising cetuximab IV over 1-2 hours, paclitaxel IV over 1 hour, and carboplatin IV over 1 hour on day 1. Treatment repeats weekly for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning 2-3 weeks later, patients undergo radiotherapy or chemoradiotherapy. Patients with T0, 1, 2 disease undergo radiotherapy 5 days a week for 6 weeks. Patients with T3, 4 disease or unresectable nodal disease undergo radiotherapy 5 days a week for 6 weeks and receive concurrent cisplatin IV over 1-2 hours on days 1 and 22. Some patients may undergo primary surgical resection before or instead of radiotherapy or chemoradiotherapy.

Quality of life is assessed at baseline and at 6, 12, and 24 months after completion of radiotherapy or surgery.

After study completion, patients are followed every 3 months for 2 years, every 4 months for 1 year, and every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Arms: arm 1: Cetuximab beginning weekly dose 400 mg/m\^2 intravenous (IV), and 250 mg/m\^2 weeks 2-6; Weekly Carboplatin area under the curve (AUC) 2 and Paclitaxel 135 mg/m\^2 for 6 courses.
Interventions: intervention 1: Cetuximab intervention 2: Carboplatin intervention 3: Paclitaxel intervention 4: Conventional Surgery intervention 5: Radiation Therapy
Intervention descriptions: intervention 1: Beginning weekly dose 400 mg/m\^2 IV over 1-2 hours, and 250 mg/m\^2 weeks 2-6. intervention 2: AUC 2 weekly for 6 courses. intervention 3: 135 mg/m\^2 weekly for 6 courses. intervention 4: Following induction in second part of study. intervention 5: Following induction in second part of study.

Protocol documents: