Cetuximab, Combination Chemotherapy, and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Stage III or
Stage IV Head and Neck Cancer
This study is not yet open for patient recruitment.
Sponsored by: |
Eastern Cooperative Oncology Group
|
Information provided by: |
National Cancer Institute (NCI) |
Purpose
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 paclitaxel and carboplatin, 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.
Giving a monoclonal antibody with chemotherapy and radiation therapy before surgery may shrink the tumor so that it can be
removed.
PURPOSE: Phase II trial to study the effectiveness of combining cetuximab with combination chemotherapy and radiation therapy
in treating patients who are undergoing surgery for stage III or stage IV head and neck cancer.
Condition
|
Treatment or Intervention |
Phase |
Hypopharyngeal Cancer Laryngeal Cancer lip and oral cavity cancer Oropharyngeal Cancer paranasal sinus and nasal cavity cancer Salivary Gland Cancer
|
Drug: carboplatin Drug: cetuximab Drug: paclitaxel Procedure: antibody therapy Procedure: biological response modifier therapy Procedure: chemosensitization/potentiation Procedure: chemotherapy Procedure: conventional surgery Procedure: monoclonal antibody therapy Procedure: neoadjuvant therapy Procedure: radiation therapy Procedure: radiosensitization Procedure: surgery
|
Phase II
|
MedlinePlus related topics: Head and Neck Cancer; Nasal Cancer; Oral Cancer; Salivary Gland Disorders
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Neoadjuvant Induction Therapy Comprising Cetuximab, Paclitaxel, and Carboplatin Followed By Chemoradiotherapy
Comprising Cetuximab, Paclitaxel, Carboplatin, and Radiotherapy in Patients With Stage III or IV Operable Squamous Cell Cancer
of the Head and Neck
Further Study Details:
OBJECTIVES: Primary
- Determine the effect of induction therapy comprising cetuximab, paclitaxel, and carboplatin followed by chemoradiotherapy
comprising cetuximab, paclitaxel, carboplatin, and radiotherapy on 1-year event-free survival (freedom from surgery at the
primary site and freedom from recurrence and death) in patients with stage III or IV operable squamous cell cancer of the
head and neck.
Secondary
- Determine the pathologic antitumor response at the primary site in patients treated with this regimen.
- Determine disease-free and overall survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine local/regional and distant failure rates in patients treated with this regimen.
- Determine the effect of this treatment regimen on selective biologic pathways, total and phosphorylated epidermal growth factor
receptor, ERK/MAPK, and P13K/AKT in these patients.
- Determine the quality of life of patients treated with this regimen.
OUTLINE: This is a multicenter study.
- Patients receive cetuximab IV over 1-2 hours, paclitaxel IV over 3 hours, and carboplatin IV over 30 minutes on days 1, 8,
15, 22, 29, and 36. During week 7 or 8, patients undergo biopsy and evaluation of the primary site. Patients then proceed
to chemoradiotherapy.
- Chemoradiotherapy (weeks 9-13): Patients receive cetuximab IV over 1 hour, paclitaxel IV over 1 hour, and carboplatin IV over
15 minutes on days 57, 64, 71, 78, and 85. Patients also undergo radiotherapy once daily, 5 days a week, on weeks 9-13. Patients
with a negative biopsy at week 7 or 8 and who achieve a complete clinical and pathological response at the primary site after
induction therapy receive additional chemoradiotherapy beginning at week 14. Patients receive cetuximab, carboplatin, and
paclitaxel as in chemoradiotherapy (as outlined above) on days 92, 99, and 106 (weeks 14-16). Patients also undergo radiotherapy
once daily, 5 days a week, on weeks 15 and 16. Patients with N1-N3 disease undergo neck dissection on weeks 20-21.
Patients with a positive biopsy at week 7 or 8 or persistent tumor at the primary site after induction therapy undergo a second
biopsy on week 14. Patients with a negative biopsy at week 14 receive additional chemoradiotherapy (as outlined above) on
weeks 14-16. Patients with N1-N3 disease undergo neck dissection on weeks 20-21. Patients with a positive biopsy at week 14
do not receive additional chemoradiotherapy, but rather undergo surgical resection of the primary site on weeks 18-19. Patients
with N1-N3 disease also undergo neck dissection at this time.
Quality of life is assessed at baseline, at weeks 7 or 8, 14, and 20 during study treatment, and then at 3, 6, and 12 months
after completion of study treatment.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study within 2.2 years.
Eligibility
Ages Eligible for Study:
18 Years
-
80 Years,
Genders Eligible for Study:
Both
DISEASE CHARACTERISTICS:
- Histologically confirmed squamous cell cancer of the head and neck
- Biopsy confirmed at the primary site
- Stage III or IV (T2-4, N1-N3)
- No nasopharyngeal cancer
- Potentially operable with a high likelihood of achieving R0 resection
- No fixed nodal metastasis to the spine or carotid artery
- No invasion of the root of the tongue, pharyngeal muscle, post pharynx, or vertebral fascia
- No invasion of laryngeal cartilage into strap muscles or tracheal invasion > 1 cm
- Measurable disease
- At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR > 10 mm by spiral CT scan
- Patients with clinically palpable cervical lymph nodes must be evaluated by CT scan and confirmed with fine needle aspiration
- Patients with non-palpable neck nodes must be evaluated by CT scan
- Radiographic findings are acceptable in the absence of clinically palpable lymph nodes
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
Renal
Cardiovascular
- No significant history of cardiac disease
- No uncontrolled hypertension
- No unstable angina
- No congestive heart failure
- No uncontrolled arrhythmias
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No known allergy to murine proteins or Cremophor EL
- No other malignancy within the past 5 years except lobular carcinoma in situ of the breast, carcinoma in situ of the cervix,
basal cell cancer, or excised and controlled cutaneous squamous cell cancer (< 200 mm thick)
PRIOR CONCURRENT THERAPY: Biologic therapy
- No prior immunotherapy for head and neck cancer
- No prior chimerized or murine monoclonal antibody therapy
- No prior anti-epidermal growth factor receptor (EGFR) antibody therapy
Chemotherapy
- No prior chemotherapy for head and neck cancer
Endocrine therapy
Radiotherapy
- No prior radiotherapy for head and neck cancer
- No concurrent cobolt-60
Surgery
- No prior surgery for head and neck cancer
Other
- No prior tyrosine kinase inhibitor therapy, including inhibitors targeting EGFR pathways
Location
Information
Study chairs or principal investigators
Harold J. Wanebo, MD, Study Chair, Roger Williams Medical Center
Barbara A. Burtness, MD, Yale Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers:
CDR0000378194; ECOG-E2303
Record last reviewed:
August 2004
Record first received:
August 4, 2004
ClinicalTrials.gov Identifier:
NCT00089297Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-20