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Status:

TERMINATED

Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer That Cannot Be Removed By Surgery

Lead Sponsor:

Radiation Therapy Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Head and Neck Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stoppin...

Detailed Description

OBJECTIVES: Primary * Compare overall survival of patients with previously irradiated unresectable locally recurrent squamous cell carcinoma of the head and neck treated with radiotherapy, cisplatin...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically\* or cytologically\* confirmed squamous cell carcinoma (SCC) of the oral cavity, oropharynx, hypopharynx, or larynx, including any of the following histologic variants:
  • Spindle cell carcinoma
  • Poorly differentiated keratin-positive carcinoma
  • Lymphoepithelioma NOTE: \*Biopsy or primary tumor and/or fine needle aspiration of the metastatic lymph node required
  • Original or second primary tumor
  • Recurrent neck metastases with unknown primary allowed
  • Locally recurrent disease
  • Measurable disease
  • Unresectable disease
  • Attempted surgical resection allowed provided surgery was performed ≥ 3 months ago, wound is completely healed, and there is no sign of carotid exposure
  • Must have had prior radiotherapy for SCC of the head and neck with \> 75% of the present tumor volume in areas irradiated at doses ≥ 45 Gy but ≤ 75 Gy
  • Able to successfully re-irradiate the area of the gross tumor volume without exceeding lifetime spinal cord dose of 54 Gy as determined by physical examination and CT scan and/or MRI performed within the past 8 weeks
  • First recurrence occurred \> 6 months after completion of radiotherapy
  • More than 1 recurrence allowed provided the above criteria for first recurrence has been met
  • No primary tumor of the nasopharynx or salivary gland
  • No distant metastases by history or physical examination, chest CT scan, and CT scan or MRI of the tumor site
  • Patients with equivocal pulmonary nodules are eligible provided the nodules are \< 1 cm, can be safely biopsied, or are negative by positron emission tomography imaging
  • No circumferential tumor involvement of the carotid sheath by imaging unless prophylactic carotid stent is placed
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • Zubrod 0-1
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Absolute neutrophil count ≥ 1,800/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)
  • Hepatic
  • AST or ALT \< 2 times upper limit of normal (ULN)
  • Bilirubin \< 1.5 mg/dL
  • No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
  • Renal
  • Creatinine clearance \> 50 mL/min
  • Calcium \< 11.5 mg/dL
  • Cardiovascular
  • No New York Heart Association class III or IV heart disease
  • No other symptomatic or uncontrolled cardiac disease
  • Pulmonary
  • No chronic obstructive pulmonary disease exacerbation
  • No other respiratory illness requiring hospitalization within the past 6 months or that would preclude study therapy
  • Immunologic
  • No AIDS
  • No prior allergic reaction to E. coli-derived products
  • No acute bacterial or fungal infection requiring IV antibiotics
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 30 days after completion of study treatment
  • No other invasive malignancy within the past 3 years except nonmelanoma skin cancer, carcinoma in situ of the breast, oral cavity, or cervix
  • No pre-existing peripheral sensory neuropathy \> grade 2
  • No other severe active co-morbidity
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • Not specified
  • Chemotherapy
  • At least 6 months since prior chemotherapy
  • No prior systemic chemotherapy for recurrent SCC of the head and neck
  • Prior neoadjuvant, adjuvant, and/or concurrent chemotherapy and radiotherapy for initial SCC of the head and neck allowed
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • See Disease Characteristics
  • See Chemotherapy
  • At least 6 months since prior radiotherapy
  • Surgery
  • See Disease Characteristics
  • Other
  • Prior cyclooxygenase-2 inhibitor or retinoids for chemoprevention allowed
  • At least 6 months since prior epidermal growth factor receptor (EGFR) inhibitors or other targeted agents
  • No prior EGFR inhibitors or other targeted agents for recurrent SCC of the head and neck
  • No concurrent cimetidine or allopurinol (for patients on arm II, regimen 1)

Exclusion

    Key Trial Info

    Start Date :

    April 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    15 Patients enrolled

    Trial Details

    Trial ID

    NCT00113399

    Start Date

    April 1 2005

    Last Update

    July 2 2013

    Active Locations (125)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 32 (125 locations)

    1

    University of Alabama at Birmingham Comprehensive Cancer Center

    Birmingham, Alabama, United States, 35294

    2

    Mobile Infirmary Medical Center

    Mobile, Alabama, United States, 36652-2144

    3

    St. Joseph's Mercy Cancer Center

    Hot Springs, Arkansas, United States, 71913

    4

    Auburn Radiation Oncology

    Auburn, California, United States, 95603