Clinical trial NCT00721513
Conditions: Head and Neck Cancer
Keywords: stage III squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the oropharynx stage III squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the larynx stage III verrucous carcinoma of the larynx stage IV squamous cell carcinoma of the larynx stage IV verrucous carcinoma of the larynx
Sponsor: Wake Forest University Health Sciences
Start date: 2008-09-01; Completion date: 2014-08-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with cetuximab and radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving docetaxel, cisplatin, and fluorouracil together with cetuximab and radiation therapy works in treating patients with locally advanced head and neck cancer.

Detailed description:
OBJECTIVES:

Primary

* Evaluate the progression-free survival of patients with locally advanced squamous cell carcinoma of the head and neck treated with induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil followed by concurrent cetuximab and radiotherapy.

Secondary

* Assess the objective response rate in patients treated with this regimen.
* Assess the best overall response rate, overall survival, local-regional control, and distant failure in patients treated with this regimen.
* Assess the acute and long-term toxicity associated with this regimen in these patients.
* Assess quality of life and swallowing in patients treated with this regimen.
* Determine the accuracy of PET/CT scan in evaluating objective response; in detecting residual disease at primary sites and nodes; in guiding the recommendation for salvage surgery or for neck dissection; and in early detection of recurrent or metastatic disease.

OUTLINE: Patients are stratified according to nodal status (N2b-c or N3 vs N0-2a), tumor characteristics of invasiveness (present vs absent), human papilloma virus (HPV) status (positive vs negative), and primary tumor site (hypopharynx vs larynx vs oropharynx).

Patients receive induction chemotherapy comprising docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1 and fluorouracil IV continuously on days 1-4. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-4 weeks after completion of induction chemotherapy, patients receive cetuximab IV once weekly for 7 weeks. Beginning 1 week after the first dose of cetuximab, patients undergo concurrent intensity-modulated radiotherapy or conventional 3-dimensional radiotherapy once or twice daily 5-6 days a week for up to 6 weeks. Patients with persistent disease undergo salvage resection of the primary tumor and/or neck dissection approximately 3 months after the completion of radiotherapy.

Patients undergo quality of life and swallowing evaluations periodically.

Patients undergo PET/CT scan at baseline, before beginning radiotherapy, at 6-8 weeks after completion of study treatment, every 6 months for 5 years, and then annually thereafter.

After completion of study treatment, patients are followed at 4 and 8 weeks, every 2 months for 2 years, every 3 months for 1 year, and then every 6 months thereafter.

Arms: arm 1: Taxotere/Cisplatinum/5-Fluorouracil (TPF) Chemotherapy Followed by Concomitant Cetuximab \& Radiation Therapy
Interventions: intervention 1: cetuximab intervention 2: cisplatin intervention 3: docetaxel intervention 4: fluorouracil intervention 5: computed tomography intervention 6: positron emission tomography intervention 7: quality-of-life assessment intervention 8: 3-dimensional conformal radiation therapy intervention 9: intensity-modulated radiation therapy
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None intervention 8: None intervention 9: None

Protocol documents: