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
18 Years
N/A
Both
Chemotherapeutic Agent Toxicity, Head and Neck Cancer, Mucositis, Radiation Toxicity, Xerostomia
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Rate of local/regional control (LRC) 1 year after beginning treatment
Safety Issue:
No
Principal Investigator
Robert I. Haddad, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Dana-Farber Cancer Institute
Authority:
United States: Federal Government
Study ID:
CDR0000393493
NCT ID:
NCT00095927
Start Date:
May 2003
Completion Date:
Related Keywords:
- Chemotherapeutic Agent Toxicity
- Head and Neck Cancer
- Mucositis
- Radiation Toxicity
- Xerostomia
- radiation toxicity
- chemotherapeutic agent toxicity
- mucositis
- xerostomia
- stage II squamous cell carcinoma of the lip and oral cavity
- stage III squamous cell carcinoma of the lip and oral cavity
- stage IV squamous cell carcinoma of the lip and oral cavity
- stage II squamous cell carcinoma of the oropharynx
- stage III squamous cell carcinoma of the oropharynx
- stage IV squamous cell carcinoma of the oropharynx
- stage II squamous cell carcinoma of the hypopharynx
- stage III squamous cell carcinoma of the hypopharynx
- stage IV squamous cell carcinoma of the hypopharynx
- stage II squamous cell carcinoma of the larynx
- stage III squamous cell carcinoma of the larynx
- stage IV squamous cell carcinoma of the larynx
- stage II squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
- untreated metastatic squamous neck cancer with occult primary
- metastatic squamous neck cancer with occult primary squamous cell carcinoma
- Neoplasms, Squamous Cell
- Head and Neck Neoplasms
- Xerostomia
- Radiation Injuries
- Mucositis
Name | Location |
|---|---|
| Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
| Bethke Cancer Center at Emerson Hospital | Concord, Massachusetts 01742 |
| Lowell General Hospital | Lowell, Massachusetts 01854 |
| Hudner Oncology Center at Saint Anne's Hospital - Fall River | Fall River, Massachusetts 02721 |
| NSMC Cancer Center - Peabody | Peabody, Massachusetts 01960 |
