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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-16

Study Completion Date

2017-10-03

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma Recurrent Metastatic Squamous Neck Cancer With Occult Primary Recurrent Salivary Gland Cancer Recurrent Squamous Cell Carcinoma of the Hypopharynx Recurrent Squamous Cell Carcinoma of the Larynx Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity Recurrent Squamous Cell Carcinoma of the Nasopharynx Recurrent Squamous Cell Carcinoma of the Oropharynx Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity Recurrent Verrucous Carcinoma of the Larynx Recurrent Verrucous Carcinoma of the Oral Cavity Salivary Gland Squamous Cell Carcinoma Stage IV Salivary Gland Cancer Stage IV Squamous Cell Carcinoma of the Hypopharynx Stage IV Squamous Cell Carcinoma of the Larynx Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity Stage IV Squamous Cell Carcinoma of the Nasopharynx Stage IV Squamous Cell Carcinoma of the Oropharynx Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity Stage IV Verrucous Carcinoma of the Larynx Stage IV Verrucous Carcinoma of the Oral Cavity Tongue Cancer Untreated Metastatic Squamous Neck Cancer With Occult Primary

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Patients receive cetuximab 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 PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

cetuximab

Intervention Type BIOLOGICAL

Given IV

paclitaxel

Intervention Type DRUG

Given IV

carboplatin

Intervention Type DRUG

Given IV

erlotinib hydrochloride

Intervention Type DRUG

Given PO

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

Interventions

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cetuximab

Given IV

Intervention Type BIOLOGICAL

paclitaxel

Given IV

Intervention Type DRUG

carboplatin

Given IV

Intervention Type DRUG

erlotinib hydrochloride

Given PO

Intervention Type DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type OTHER

Other Intervention Names

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C225 C225 monoclonal antibody IMC-C225 MOAB C225 monoclonal antibody C225 Anzatax Asotax TAX Taxol Carboplat CBDCA JM-8 Paraplat Paraplatin CP-358,774 erlotinib OSI-774

Eligibility Criteria

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Exclusion Criteria

* Patients must have no history of allergic reaction to murine proteins
* Ability to understand and the willingness to sign a written informed consent
* Patients must not be receiving other investigational anti-cancer therapy
* Patients with brain metastases are not eligible
* Both men and women and members of all races and ethnic groups are eligible for this trial

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No