This phase II trial studies how well cisplatin, nab-paclitaxel, and cetuximab work in treating patients with head and neck squamous cell carcinoma that has spread to another place in the body, has come back locally, or cannot be removed by surgery. Drugs used in chemotherapy, such as cisplatin and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as cetuximab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cisplatin, nab-paclitaxel, and cetuximab may be an effective treatment for cancer of the oral cavity, oropharynx, larynx, or hypopharynx.
Additional locations may be listed on ClinicalTrials.gov for NCT02270814.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To determine progression-free survival in patients receiving cisplatin (or carboplatin), nab-paclitaxel, and cetuximab as first-line therapy for treatment of incurable head and neck squamous cell carcinoma (HNSCC).
SECONDARY OBJECTIVES:
I. To determine overall survival in patients receiving cisplatin (or carboplatin), nab-paclitaxel, and cetuximab as first-line therapy for treatment of incurable HNSCC.
II. To determine response rates in patients receiving cisplatin (or carboplatin), nab-paclitaxel, and cetuximab as first-line therapy for treatment of incurable HNSCC.
III. To evaluate the instances of grade 3 and 4 adverse events (using Common Terminology Criteria for Adverse Events [CTCAE] version 4.0) in patients receiving cisplatin (or carboplatin), nab-paclitaxel, and cetuximab as first-line therapy for treatment of incurable HNSCC.
IV. To characterize the quality of life of patients receiving cisplatin (or carboplatin), nab-paclitaxel, and cetuximab as first-line therapy for treatment of incurable HNSCC.
V. To determine progression-free survival in patients receiving maintenance therapy with nab-paclitaxel and cetuximab for treatment of incurable HNSCC.
EXPLORATORY OBJECTIVES:
I. To perform mutational analysis (phosphatidylinositol-4,5-bisphosphate 3-kinase [PI3K] pathway and Harvey rat sarcoma viral oncogene homolog [H-Ras]) on tumor tissue collected from patients with incurable HNSCC.
II. To perform immunohistochemical analyses (epidermal growth factor receptor [EGFR], v-akt murine thymoma viral oncogene homolog 1 [AKT], phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha [PIK3CA], phosphatase and tensin homolog [PTEN], MET proto-oncogene, receptor tyrosine kinase [MET], and protein [p]S6 kinase) on tumor tissue collected from patients with incurable HNSCC.
III. To perform immune activation analyses (tumor infiltrating lymphocytes [TIL] markers, programmed cell death [PD]-ligand [L]1) on tumor tissue collected from patients with incurable HNSCC.
OUTLINE:
Patients receive cisplatin* intravenously (IV) over 60 minutes or carboplatin IV over 30 minutes on day 1, nab-paclitaxel IV over 30 minutes and cetuximab IV on days 1, 8, and 15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients receive maintenance chemotherapy comprising nab-paclitaxel IV over 30 minutes on days 1 and 8 and cetuximab IV on days 1, 8, and 15. Maintenance treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
*NOTE: Cisplatin is preferred, but carboplatin may be given if the patient has a prior intolerance to cisplatin or at the discretion of the treating physician.
After completion of study treatment, patients are followed up every 3 months.
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorDouglas Ray Adkins
