Paclitaxel, Carboplatin and Cetuximab (PCC) With Cetuximab, Docetaxel, Cisplatin and Fluorouracil… (NCT01154920) | Clinical Trial Compass
Active — Not RecruitingPhase 2
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
United States128 participantsStarted 2010-07-09
Plain-language summary
The goal of this clinical research study is to learn which chemotherapy combination is more effective in treating locally advanced head and neck squamous cell carcinoma. The side effects of these combinations will also be studied.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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)
Exclusion criteria
✕. Histology other than squamous cell carcinoma
✕. Proven distant metastases (below the clavicle) by clinical or radiographic measures
What they're measuring
1
Number of Patients with Progression-Free Survival (PFS)