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A Pilot Study of Combined Modality Therapy for Recurrent Head and Neck Carcinoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

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Trial Information

A Pilot Study of Combined Modality Therapy for Recurrent Head and Neck Carcinoma


OBJECTIVES:

- Determine the effectiveness and toxic effects of intensive salvage therapy and
radiotherapy in previously irradiated patients with recurrent head and neck cancer.

- Determine the feasibility and effectiveness of amifostine at limiting or minimizing
side effects of repeat irradiation in these patients.

OUTLINE: Patients undergo surgical resection of gross disease (if not already done) followed
by 4-6 weeks of rest. Patients receive radiotherapy over 5 consecutive days on weeks 1, 2,
4, and 5. Intravenous cisplatin is administered on days 1-3 and 29-31. Intravenous
amifostine is administered 15-30 minutes prior to radiotherapy and cisplatin therapy.
Patients receive fluorouracil IV continuously on days 1-4 and 29-32.

Patients are followed every month for 1 year, every 2 months for 1 year, every 3 months for
1 year, every 4 months for 1 year, then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed recurrent or new primary squamous cell carcinoma of the head
and neck occurring in a previously irradiated field

- Pathologic stage of recurrence must be rT3-4 and/or rN2-3

- The following sites are eligible:

- Oral cavity, oropharynx, or hypopharynx: Any rT2-4 and/or clinical rN+

- Larynx: Any rT4, rT3 with perineural invasion, or any rT with clinical rN+

- Any site: Positive margin(s), at least 2 nodes or ECS

- No primary tumor of the nasopharynx

- Must be eligible for or have undergone complete resection which leaves behind no
gross residual disease

- Must have prior head and neck irradiation of 45-75 Gy

- Lifetime spinal cord radiotherapy dose no greater than 50 Gy

- No ongoing RTOG late morbidity of grade 3 or greater (unless correctable by surgery)

- No active acute radiation mucositis from previous radiotherapy

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 70-100%

Life expectancy:

- Not specified

Hematopoietic:

- WBC at least 4,000/mm^3

- Hemoglobin at least 9 g/dL (transfusion allowed)

- Platelet count at least 100,000/mm^3

Hepatic:

- SGOT or SGPT no greater than 3 times upper limit of normal

- Bilirubin no greater than 2 mg/dL

Renal:

- Creatinine no greater than 1.5 mg/dL

Cardiovascular:

- No myocardial infarction, unstable angina, coronary heart failure, or uncontrolled
arrhythmias within past 6 months

- No severe cerebrovascular disease or hypotension not caused by antihypertensive
medication

Other:

- Not pregnant

- Fertile patients must use effective contraception

- No allergy to cisplatin, fluorouracil, or amifostine

- No uncontrolled insulin-dependent diabetes mellitus or other medical condition
interfering with wound healing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy for tumor recurrence (except adjuvant chemotherapy)

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

- At least 6 months since prior radiotherapy

- Prior radiotherapy treatment records must be available

Surgery:

- No prior salvage surgery consisting of partial laryngectomy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Mitchell Machtay, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

United States: Federal Government

Study ID:

CDR0000066906

NCT ID:

NCT00003777

Start Date:

December 1998

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • stage III lip and oral cavity cancer
  • stage IV lip and oral cavity cancer
  • recurrent lip and oral cavity cancer
  • stage III hypopharyngeal cancer
  • stage IV hypopharyngeal cancer
  • recurrent hypopharyngeal cancer
  • stage III laryngeal cancer
  • stage IV laryngeal cancer
  • recurrent laryngeal cancer
  • stage III paranasal sinus and nasal cavity cancer
  • stage IV paranasal sinus and nasal cavity cancer
  • recurrent paranasal sinus and nasal cavity cancer
  • stage III oropharyngeal cancer
  • stage IV oropharyngeal cancer
  • recurrent oropharyngeal cancer
  • Head and Neck Neoplasms

Name

Location
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104