Carboplatin, Paclitaxel, Cetuximab, and Erlotinib Hydrochloride in Treating Patients With Metastatic or Recurrent Head and Neck Squamous Cell Cancer

• Baseline tumor measurements as assessed by CT Scan of the chest and MRI and CT Scan of the neck [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  Measurable and non measurable tumor assessment as determined by RECIST v 1.1 less than 4 weeks prior to cycle 1
  
  
• Pre treatment tumor assessment by CT Scan of the chest and MRI and CT Scan of the neck to measure change from baseline tumor status [ Time Frame: Beginning of cycle 2 ] [ Designated as safety issue: No ]
  Tumor assessment as determined by RECIST v 1.1 for best response following cycle 1. Patients with progressive disease may continue if deemed medically appropriate.
  
  
• A change in tumor measurement as assessed by CT Scan of the chest and MRI and CT Scan of the neck following the following the start of the four drug measurement. [ Time Frame: beginning of cycle 4 ] [ Designated as safety issue: No ]
  Tumor response as determined by RECIST v 1.1. first achievement of partial response after cycle 2 and prior to the start of cycle 4 will be measured
  
  
• Tumor measurement every 9 weeks as assessed by CT scan of the chest and MRI and CT Scan of the Neck [ Time Frame: end of cycle 4 ] [ Designated as safety issue: No ]
  Tumor assessment as determined by RECIST v 1.1.time to best response and best response status
  
  

• Safety and Tolerability [ Time Frame: Weekly and within 30 days of termination of study treatment ] [ Designated as safety issue: Yes ]
  Hematologic, skin rash, pulmonary events, diarrhea will be examined after the first 15 and first 30 patients (two interim points); the trial will be stopped early if death related to treatment occurs in 1 of the first 15 and 2 of the next 15 participants enrolled
  
  
• Overall survival [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
  
• EGFR assay levels [ Time Frame: Between courses 1 and 2 ] [ Designated as safety issue: No ]
  Investigate if EGFR assay levels in patients vary between cycle 1 (prior to erlotinib is added) and cycle two (after erlotinib is added)and perform similar tests for biomarkers related to EGFR. Spearman correlations will be used to assess associations of biomarkers with each other
  
  
• Response rates [ Time Frame: At baseline, beginning of courses 2 and 4, and then every 9 weeks thereafter ] [ Designated as safety issue: No ]
  To be determined by measurement of target lesions according to RECIST criteria
  
  
• Variation of biomarkers related to EGFR [ Time Frame: Between courses 1 and 2 ] [ Designated as safety issue: No ]
  Investigate if EGFR assay levels in patients vary between cycle 1 (prior to erlotinib is added) and cycle two (after erlotinib is added)and perform similar tests for biomarkers related to EGFR. Spearman correlations will be used to assess associations of biomarkers with each other
  
  

PRIMARY OBJECTIVES:

I. To determine the objective response rate of carboplatin/paclitaxel/cetuximab and erlotinib therapy in recurrent/metastatic squamous cell cancer of the head and neck.

SECONDARY OBJECTIVES:

I. Secondary endpoints will be toxicity, overall survival, and laboratory correlates to determine if epidermal growth factor receptor (EGFR) signaling is more effectively inhibited after the addition of erlotinib than it is after chemotherapy/cetuximab without erlotinib.

OUTLINE:

Patients receive cetuximab intravenously (IV) over 60 minutes, paclitaxel IV over 1 hour, and carboplatin IV over 30 minutes on day 1. Beginning in course 2, patients also receive erlotinib hydrochloride orally (PO) once daily (QD) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months.