Docetaxel, Cisplatin, and Fluorouracil Followed By Cetuximab and Radiation Therapy in Treating Pa… (NCT00721513) | Clinical Trial Compass
CompletedPhase 2
Docetaxel, Cisplatin, and Fluorouracil Followed By Cetuximab and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer
United States20 participantsStarted 2008-09
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with cetuximab and radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel, cisplatin, and fluorouracil together with cetuximab and radiation therapy works in treating patients with locally advanced 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.
Inclusion:
* Histologically confirmed (from primary lesion and/or lymph nodes) squamous cell carcinoma (SCC) of the head and neck, including the following subtypes:
* Oropharynx
* Hypopharynx
* Larynx
* Primary site of tumor must not include any of the following:
* Nasopharynx
* Sinuses
* Salivary glands
* Stage III or IV disease that is unresectable (oropharynx, larynx, or hypopharynx) OR that is resectable with organ-sparing goal (oropharynx or hypopharynx)
* Measurable disease by CT scan or MRI
* No definitive evidence of distant metastasis
* ECOG performance status 0-1
* ANC ≥ 1,500/μL
* Platelet count ≥ 100,000/μL
* Hemoglobin ≥ 8 g/dL
* Total bilirubin ≤ normal
* Except in the case where the elevated total bilirubin is not a sign of liver disease (i.e., Gilbert syndrome), in which case a total bilirubin ≤ 2 times upper limit of normal (ULN) is allowed provided direct bilirubin is ≤ ULN
* AST, ALT, and alkaline phosphate (AP) meeting the following criteria:
* AP normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)
* AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
* AP ≤ 5 times ULN AND AST or ALT normal
* Creatinine ≤ 1.5 mg/dL
* Negative pregnancy test (for women of childbearing potential)
* Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
* Willing to undergo laryngoscopy with biopsy of residual tumor at primary site (as part of a comprehensive evaluation of tumor response …