Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Recurrent Head and Neck Cancer

Abramson Cancer Center at Penn Medicine

Status and phase

Terminated

Phase 2

Conditions

Head and Neck Cancer

Treatments

Procedure: surgical procedure

Drug: fluorouracil

Drug: amifostine trihydrate

Drug: cisplatin

Radiation: radiation therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00003777

NCI-V99-1518

ALZA-98-023-ii

UPCC-6398

CDR0000066906

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy use 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. Drugs such as amifostine may prevent the side effects of radiation therapy. Combining more than one drug and combining radiation therapy and surgery with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining surgery, radiation therapy, and combination chemotherapy in treating patients who have recurrent head and neck cancer that has been treated previously with radiation therapy.

Full description

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.

Enrollment

35 estimated patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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: