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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Phase II Trial of Carboplatin/Paclitaxel and Cetuximab, Followed by Carboplatin/Paclitaxel/Cetuximab and Erlotinib, With Correlative Studies in Patients With Metastatic or Recurrent Squamous Cell Carc

Brief Summary: This phase II trial is studying how well giving carboplatin, paclitaxel, cetuximab, and erlotinib hydrochloride together works in treating patients with metastatic or recurrent squamous cell head and neck cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with cetuximab and erlotinib hydrochloride may kill more tumor cells.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To determine the objective response rate when erlotinib is added to combination carboplatin/paclitaxel/cetuximab systemic therapy in metastatic/recurrent head and neck cancer.

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.


Sponsor: Fox Chase Cancer Center

Current Primary Outcome: Objective response rate [ Time Frame: Up to 3 years ]

Complete plus partial response as determined by RECIST v 1.1


Original Primary Outcome:

  • Baseline tumor measurements as assessed by CT Scan of the chest and MRI and CT Scan of the neck [ Time Frame: Baseline ]
    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 ]
    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 ]
    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 ]
    Tumor assessment as determined by RECIST v 1.1.time to best response and best response status


Current Secondary Outcome:

  • Toxicity of study treatment [ Time Frame: Up to 30 days post-treatment ]
    Assessed by National Cancer Institute (NCI) Common Toxicity Criteria (CTCAE) v.4.0. Proportions and 95% confidence intervals will be used.
  • Overall survival [ Time Frame: Up to 3 years ]
    Will use Kaplan-Meier curves.
  • EGFR assay levels [ Time Frame: Between courses 1 and 2 ]
    Will use a Wilcoxon paired-sample test.
  • Response rates [ Time Frame: Up to 3 years ]
    Proportions and 95% confidence intervals
  • Biomarkers related to EGFR [ Time Frame: Between courses 1 and 2 ]
    Will use Spearman correlations to assess the associations of the biomarkers with each other.


Original Secondary Outcome:

  • Safety and Tolerability [ Time Frame: Weekly and within 30 days of termination of study treatment ]
    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 ]
  • EGFR assay levels [ Time Frame: Between courses 1 and 2 ]
    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 ]
    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 ]
    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


Information By: Fox Chase Cancer Center

Dates:
Date Received: March 8, 2011
Date Started: February 16, 2011
Date Completion: October 7, 2017
Last Updated: April 11, 2017
Last Verified: January 2017