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

This study is ongoing, but not recruiting participants.

Sponsored by: University of Pennsylvania
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003777
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Drug: amifostine trihydrate
Drug: cisplatin
Drug: fluorouracil
Procedure: radiation therapy
Procedure: surgical procedure
Phase II

MedlinePlus related topics:   Cancer    Head and Neck Cancer   

Drug Information available for:   Cisplatin    Fluorouracil    Amifostine    Salicylsalicylic acid    Sodium salicylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Pilot Study of Combined Modality Therapy for Recurrent Head and Neck Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   35
Study Start Date:   December 1998

Detailed 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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003777

Locations
United States, Pennsylvania
University of Pennsylvania Cancer Center    
      Philadelphia, Pennsylvania, United States, 19104-4283

Sponsors and Collaborators
University of Pennsylvania

Investigators
Study Chair:     Mitchell Machtay, MD     University of Pennsylvania    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000066906, UPCC-6398, ALZA-98-023-ii, NCI-V99-1518
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003777
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Amifostine
Salicylsalicylic acid
Sodium Salicylate
Laryngeal Neoplasms
Lip and oral cavity cancer
Recurrence
Carcinoma
Cisplatin
Head and Neck Neoplasms
Oral cancer
Fluorouracil
Laryngeal carcinoma
Hypopharyngeal cancer

Additional relevant MeSH terms:
Antimetabolites
Radiation-Protective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Protective Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2008




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