CompletedPhase 2

Nab-Paclitaxel, Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer

United States37 participantsStarted 2008-12

Plain-language summary

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab and cisplatin together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cetuximab and cisplatin together with radiation therapy works in treating patients with recurrent head and neck cancer.

Who can participate

Age range18 Years – 120 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

DISEASE CHARACTERISTICS: * Pathologically confirmed squamous cell carcinoma (SCC) of the upper aerodigestive tract * Recurrent disease or second primary SCC * Recurrence or second primary must be confined to the head and neck above the clavicles (loco-regional recurrence) * Majority (≥ 75%) of the recurrent tumor must be in areas previously irradiated to ≥ 45 Gy * More than one recurrence allowed provided the first recurrence occurred \> 6 months after the completion of prior radiotherapy * Unresectable disease OR has high-risk features after resection (e.g., positive margins and/or extracapsular extension) * No signs of carotid exposure * No primary nasopharyngeal or salivary gland tumor * Equivocal pulmonary nodes on chest CT scan allowed provided they are \< 1 cm, cannot be safely biopsied, or are negative on PET scan * No distant metastasis PATIENT CHARACTERISTICS: * Karnofsky performance status 70-100% * ANC ≥ 2,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed) * Bilirubin \< 1.5 mg/dL * AST or ALT \< 2 times upper limit of normal * Creatinine clearance ≥ 50 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to submit prior radiotherapy records to assure that the spinal cord tolerance is not exceeded * No active cardiac disease, including any of the following: * Unstable angina * Uncontrolled hypertension * Myocardial infarct…

What they're measuring

Progression Free Survival (PFS)

Timeframe: 2 year from the date of enrollment

Trial details

NCT IDNCT00833261

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-09

Results submitted2018-11-21