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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 Ad

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Trial Conditions
  • Chemotherapeutic Agent Toxicity
  • Head and Neck Cancer
  • Mucositis
  • Radiation Toxicity
  • Xerostomia
What is the purpose of this trial?

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.

Date & Status

Active, not recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

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

Gender: Both
Steward Physician(s)
  • Robert I. Haddad, MD
Facilities
  • Saint Anne's Hospital - Active, not recruiting
Trial Interventions
Drug
  • amifostine trihydrate
  • carboplatin
  • paclitaxel
Radiation
  • radiation therapy
Physician Researcher

Investigator Name:

  • Robert I. Haddad, MD

Other Information

Sponsor: Dana-Farber Cancer Institute
Phase: Phase 2
Trial ID: NCT00095927
Volunteers:  Not Accepting Healthy Volunteers

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