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

Tongue Cancer Clinical Trial

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 Carcinoma of the Head and Neck.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01316757
• Other study ID #: FER-HN-027
• Secondary ID: NCI-2011-00272P3
• Status: Completed
• Phase: Phase 2
• First received: March 8, 2011
• Last updated: February 23, 2018
• Start date: February 16, 2011
• Est. completion date: October 3, 2017

Study information

• Verified date: January 2017
• Source: Fox Chase Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 3, 2017
• Est. primary completion date: April 7, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Criteria:

• Histologically confirmed squamous cell carcinoma of the head and neck that is metastatic or recurrent

• No prior systemic therapy for metastatic/recurrent disease

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1

• Prior chemotherapy in the induction, organ preservation or adjuvant setting is permitted if it was completed more than 4 months prior to enrollment on the current study

• Prior cetuximab is permitted if it was given for no more than 9 doses in combination with radiation therapy or chemoradiation therapy for initial treatment of locally advanced disease

• No prior erlotinib, gefitinib or lapatinib therapy is permitted; nor is prior exposure to any investigational EGFR or panErbB reversible or irreversible inhibitor or any prior panitumumab or investigational EGFR-directed monoclonal antibody permitted

• Hemoglobin > 9.0 G/dl

• Absolute neutrophil count (ANC) > 1500 cells/mcl

• Creatinine (Cr) < 1.8

• Total bilirubin =< the institution's upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine transaminase (ALT) < 2 X ULN

• No chronic active viral infection

• No other malignancy within 3 years

• No chronic diarrheal condition

• Females should not be pregnant or breast feeding because chemotherapy may be harmful to the fetus or the nursing infant; also, the effects of erlotinib and cetuximab on the developing human fetus are unknown

• All females of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy

• Women of childbearing potential and sexually active males must use an accepted and effective method of contraception while on treatment and for three months after the completion of treatment

• Patients must have measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST); baseline measurements and evaluations must be obtained within < 4 weeks of randomization; all areas of disease should be recorded and mapped out in order to assess response and uniformity of response to therapy; disease in previously irradiated sites is considered measurable if there has been unequivocal disease progression or biopsy-proven residual carcinoma following radiation therapy; persistent disease without clear-cut progression after radiotherapy can be considered measurable if biopsy-proven at least 8 weeks after completion of radiation therapy

• Patients with a prior history of squamous cell or basal carcinoma of the skin or in situ cervical cancer must have been curatively treated; patients with a history of other prior malignancy must have been treated with curative intent and must have remained disease-free for 3 years post diagnosis

• No current peripheral neuropathy > grade 2 at time of randomization

• Patients must not have any co-existing condition that would preclude full compliance with the study

• Human immunodeficiency virus (HIV) positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with erlotinib

• 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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Laryngeal Diseases
• Laryngeal Neoplasms
• Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
• Nasopharyngeal Neoplasms
• Neoplasms, Unknown Primary
• Oropharyngeal Neoplasms
• Paranasal Sinus Neoplasms
• 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 Neoplasms
• 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
• Tongue Neoplasms
• Untreated Metastatic Squamous Neck Cancer With Occult Primary

Intervention

Biological:
• cetuximab
Given IV

Drug:
• paclitaxel
Given IV
• carboplatin
Given IV
• erlotinib hydrochloride
Given PO

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Univesity of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
Fox Chase Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate	Complete plus partial response as determined by RECIST v 1.1	Up to 3 years
Secondary	Toxicity of study treatment	Assessed by National Cancer Institute (NCI) Common Toxicity Criteria (CTCAE) v.4.0. Proportions and 95% confidence intervals will be used.	Up to 30 days post-treatment
Secondary	Overall survival	Will use Kaplan-Meier curves.	Up to 3 years
Secondary	EGFR assay levels	Will use a Wilcoxon paired-sample test.	Between courses 1 and 2
Secondary	Response rates	Proportions and 95% confidence intervals	Up to 3 years
Secondary	Biomarkers related to EGFR	Will use Spearman correlations to assess the associations of the biomarkers with each other.	Between courses 1 and 2