Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Radiation Therapy, Carboplatin, and Paclitaxel With or Without Amifostine in Treating Patients With Stage II, Stage III, or Stage IV Head and Neck Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	DFCI-03018 NCT00095927

Objectives

Primary

1. 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.
2. Compare the 3- and 6-month incidence of grade 2 or 3 chronic xerostomia in patients treated with these regimens.
3. Compare the incidence of grade 3 and 4 mucositis after radiotherapy in patients treated with these regimens.
4. Compare the median duration of dependence on percutaneous endoscopic gastrectomy (PEG) for adequate nutrition in patients treated with these regimens.

Secondary

1. Compare the duration of grade 3 and 4 mucositis in patients treated with these regimens.
2. Compare the 3-, 6-, and 12-month dependence on PEG in patients treated with these regimens.
3. Compare time to disease progression in patients treated with these regimens.
4. Compare quality of life of patients treated with these regimens.
5. Compare 2-year local and regional disease control in patients treated with these regimens.
6. Compare 2-year survival of patients treated with these regimens.

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• WHO 0-1

Life expectancy

• More than 12 weeks

Hematopoietic

• Neurophil count ≥ 2,000/mm³
• Platelet count ≥ 100,000/mm³
• 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

Expected Enrollment

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

Outcomes

Rate of local/regional control (LRC) 1 year after beginning treatment
Proportion of patients with grade 2 or 3 chronic xerostomia at 3, 6, and 12 months after completion of study treatment
Proportion of patients with grade 3 and 4 mucositis as assessed by RTOG criteria once weekly during and after completion of radiotherapy
Median duration of dependence on percutaneous endoscopic gastrectomy (PEG) for adequate nutrition at 8, 12, 24, and 52 weeks after completion of study treatment

Duration of grade 3 and 4 mucositis once weekly during treatment and at 8, 12, 24, and 52 weeks after completion of study treatment
Proportion of patients with PEG dependency at 3, 6, and 12 months after completion of study treatment
Time to disease progression
Quality of life as assessed by Functional Assessment of Cancer Therapy for Head and Neck Cancer (FACT-H&N) Survey at baseline and 8, 12, 24, and 52 weeks after completion of study treatment
LRC and overall survival at 2 years after completion of study treatment

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.

Haddad R, Sonis S, Posner M, et al.: Randomized phase 2 study of concomitant chemoradiotherapy using weekly carboplatin/paclitaxel with or without daily subcutaneous amifostine in patients with locally advanced head and neck cancer. Cancer 115 (19): 4514-23, 2009.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

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

Robert Haddad, MD, Protocol chair		Ph: 617-632-3090; 866-790-4500

Registry Information
Official Title		Phase II, Randomized Study of Concomitant Chemoradiation Using Weekly Carboplatinum/Paclitaxel With (Arm A) or Without (Arm B) Daily Subcutaneous Amifostine in Patients with Newly Diagnosed Locally Advanced Squamous Cell Cancer of the Head and Neck
Trial Start Date		2003-05-07
Trial Completion Date		2009-06-05 (estimated)
Registered in ClinicalTrials.gov		NCT00095927
Date Submitted to PDQ		2004-09-21
Information Last Verified		2009-06-04
NCI Grant/Contract Number		CA06516

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