Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, 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. Combining chemotherapy with radiation therapy may kill more tumor cells. Amifostine may protect normal cells from the side effects of chemotherapy and radiation therapy.

PURPOSE: This randomized phase II trial is studying giving amifostine together with radiation therapy, carboplatin, and paclitaxel to see how well it works compared to radiation therapy, carboplatin, and paclitaxel in treating patients with newly diagnosed stage II, stage III, or stage IV head and neck cancer.

Further Study Information

OBJECTIVES:

Primary

• Compare the 1-year rate of local and regional disease control in patients with newly diagnosed stage II, III, or IV squamous cell carcinoma of the head and neck treated with concurrent radiotherapy and chemotherapy comprising carboplatin and paclitaxel with vs without amifostine.

• Compare the 3- and 6-month incidence of grade 2 or 3 chronic xerostomia in patients treated with these regimens.

• Compare the incidence of grade 3 and 4 mucositis after radiotherapy in patients treated with these regimens.

• Compare the median duration of dependence on percutaneous endoscopic gastrectomy (PEG) for adequate nutrition in patients treated with these regimens.

Secondary

• Compare the duration of grade 3 and 4 mucositis in patients treated with these regimens.

• Compare the 3-, 6-, and 12-month dependence on PEG in patients treated with these regimens.

• Compare time to disease progression in patients treated with these regimens.

• Compare quality of life of patients treated with these regimens.

• Compare 2-year local and regional disease control in patients treated with these regimens.

• Compare 2-year survival of patients treated with these regimens.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive carboplatin and paclitaxel once weekly for 6 weeks. Patients also undergo radiotherapy, concurrently with chemotherapy, once daily for 4 weeks and then twice daily for 2 weeks.

• Arm II: Patients receive chemoradiotherapy as in arm I. Patients also receive amifostine subcutaneously once daily.

Quality of life is assessed at baseline and then at 8, 12, 24, and 52 weeks after completion of study therapy.

Patients are followed at 8, 12, 24, and 52 weeks.

PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed squamous cell carcinoma of the head and neck

• Stage II, III, or IV disease

• No evidence of distant metastases by chest x-ray, abdominal ultrasound, or CT scan (for patients with liver function abnormalities) or bone scan (for patients with local symptoms)

• Biopsy preferred unless medically contraindicated

• One of the following primary tumor sites:

• Oral cavity

• Oropharynx

• Hypopharynx

• Larynx

• Nasal cavity

• Paranasal cavity

• Unknown primary with metastasis to the head and neck region

• At least 1 uni- or bi-dimensionally measurable lesion

• No prior curative surgery for head and neck cancer

• Biopsy allowed

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• WHO 0-1

Life expectancy

• More than 12 weeks

Hematopoietic

• Neurophil count ≥ 2,000/mm^3

• Platelet count ≥ 100,000/mm^3

• Hemoglobin ≥ 10 g/dL

Hepatic

• Bilirubin normal

• AST and ALT ≤ 2.5 times upper limit of normal (ULN)*

• Alkaline phosphatase ≤ 5 times ULN* NOTE: *Patients with AST or ALT > 1.5 times ULN AND alkaline phosphatase > 2.5 times ULN are not eligible

Renal

• Creatinine clearance ≥ 60 mL/min

Cardiovascular

• No unstable cardiac disease despite treatment

• No myocardial infarction within the past 6 months

Pulmonary

• No chronic obstructive pulmonary disease requiring hospitalization within the past year

Other

• No symptomatic peripheral neuropathy ≥ grade 2

• No weight loss > 20% of body weight within the past 3 months (unless purposeful)

• No other malignancy within the past 3 years except adequately treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, or other cancer curatively treated by surgery

• Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior biologic therapy

Chemotherapy

• Prior induction chemotherapy for head and neck cancer allowed before radiotherapy begins

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy to the head and neck

Surgery

• See Disease Characteristics

Trial Contact Information

Trial Lead Organizations/Sponsors

Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

Robert I. Haddad

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00095927
Information obtained from ClinicalTrials.gov on December 14, 2011

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