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Active Not Recruiting
NCT01154920
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
Conditions: Head and Neck Squamous Cell Carcinoma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 128
Sponsor: M.D. Anderson Cancer Center
Location: Dana Farber Cancer Institute Boston Massachusetts
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.
Eligibility Criteria
Inclusion Criteria:
1. Patients with biopsy-proven squamous cell carcinoma of the oropharynx, oral cavity, nasopharynx, hypopharynx, or larynx.
2. Biopsy material sufficient for HPV status determination available
3. 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.
4. Patients with stage Tx primary disease are eligible if there is N2b-c/3 lymphadenopathy
5. ECOG PS 0-1
6. Age \>/= 18 years
7. 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 \
Source: ClinicalTrials.gov (NCT01154920). StuddyBuddy aggregates publicly available trial information.