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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Chemotherapeutic Agent Toxicity, Head and Neck Cancer, Mucositis, Radiation Toxicity, Xerostomia

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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 CenterBoston, Massachusetts  02215
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
Bethke Cancer Center at Emerson HospitalConcord, Massachusetts  01742
Lowell General HospitalLowell, Massachusetts  01854
Hudner Oncology Center at Saint Anne's Hospital - Fall RiverFall River, Massachusetts  02721
NSMC Cancer Center - PeabodyPeabody, Massachusetts  01960