Paclitaxel, Carboplatin and Cetuximab (PCC) With Cetuximab, Docetaxel, Cisplatin and Fluorouracil (C-TPF) in Previously Untreated Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma

Korábbi kezelés

• Prior chemotherapy, within the previous 3 years
• Prior radiotherapy to the head and neck

Más betegség

• Initial surgical resection rendering the patient clinically and radiologically disease free
• Simultaneous primary invasive cancers, excluding superficial non-melanoma skin cancers
• Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80

Laborértékek

• Prior cetuximab therapy or prior therapy with any other drug that targets the EGFR pathway
• Hemoglobin < 8.0g/dL

Életkor

• Patients with a history of another malignancy (excluding non melanoma skin cancers, and cancers treated > 3 years prior for which patient remains continuously disease free

Egyéb

• Histology other than squamous cell carcinoma
• Proven distant metastases (below the clavicle) by clinical or radiographic measures
• ECOG>1
• Men and women of childbearing potential (WOCBP) unwilling to consent to using effective contraception while on treatment and for at least 3 months thereafter
• Women who are pregnant or breastfeeding
• Pre-existing peripheral neuropathy CTCAE Grade 2 or worse

• Patients with biopsy-proven squamous cell carcinoma of the oropharynx, oral cavity, nasopharynx, hypopharynx, or larynx.
• Biopsy material sufficient for HPV status determination available
• Patients should have stage IV disease, stage T0-4 N2b-2c/3 M0 (for nasopharynx patients, stage N1 is eligible). Measurable disease in either the T or N site by RECIST is required.
• Patients with stage Tx primary disease are eligible if there is N2b-c/3 lymphadenopathy
• ECOG PS 0-1
• Age >/= 18 years
• Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC >/= 1500 cells/mm\^3 and platelet count >/= 100,000 cells/mm\^3; adequate hepatic function with bilirubin </= ULN (excluding Gilbert's disease), AST and ALT may be up to 2.5 x ULN if alkaline phosphatase is normal. Alkaline phosphatase may be up to 4 x ULN if AST and ALT are normal. In determining eligibility the more abnormal of the two values (AST or ALT) should be used.
• Creatinine clearance >/=40 ml/min determined by 24 hour collection or nomogram:CrCl male = (140 - age) x (wt in kg)/serum Cr x 72 or CrCl female = 0.85 x (CrCl male)
• Patients should have no serious acute or chronic co-morbid condition, or acute infection, which in the judgment of the attending physician would affect administration of the induction chemotherapy regimens.
• Patients must sign a study-specific informed consent form