A Pilot Study of Combined Modality Therapy for Recurrent Head and Neck Carcinoma
amifostine trihydrate
+ cisplatin
+ fluorouracil
Laryngeal Diseases+13
+ Stomatognathic Diseases
+ Mouth Diseases
Treatment Study
Summary
Study start date: December 1, 1998
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.35 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 120 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
University of Pennsylvania Cancer Center
Philadelphia, United StatesOpen University of Pennsylvania Cancer Center in Google Maps