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

NCT00003777 | Terminated Phase 2

• 4 other identifiers: CDR0000066906UPCC-6398ALZA-98-023-iiNCI-V99-1518
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head and Neck Cancer

Keywords

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

Interventions

amifostine trihydrate DRUG

cisplatin DRUG

fluorouracil DRUG

surgical procedure PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104-4283, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Mouth Neoplasms; Hypopharyngeal Neoplasms; Laryngeal Neoplasms; Oropharyngeal Neoplasms

Interventions

Amifostine; Cisplatin; Fluorouracil; Surgical Procedures, Operative; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms

Intervention Hierarchy (Ancestors)

Organothiophosphates; Organophosphates; Organophosphorus Compounds; Organic Chemicals; Organothiophosphorus Compounds; Sulfur Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Study Officials

• Mitchell Machtay, MD

  Abramson Cancer Center at Penn Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: December 10, 2003
• Study Start: December 1, 1998
• Primary Completion: April 1, 2001
• Study Completion: April 20, 2001
• Last Updated: January 26, 2022

Record last verified: 2022-01

Locations

US (1)