Lenalidomide and Cetuximab in Treating Patients With Advanced Colorectal Cancer or Head and Neck Cancer

Summary

This phase I trial studies the side effects and the best dose of lenalidomide when given together with cetuximab in treating patients with colorectal cancer or head and neck cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Biological therapies, such as lenalidomide, use substances made from living organisms that may stimulate the immune system in different ways and stop tumor cells from growing. Monoclonal antibodies, such as cetuximab, may block tumor growth in different ways by targeting certain cells. Giving lenalidomide together with cetuximab may be a better treatment for colorectal cancer or head and neck cancer.

Conditions

• Recurrent Colon Carcinoma
• Recurrent Hypopharyngeal Squamous Cell Carcinoma
• Recurrent Laryngeal Squamous Cell Carcinoma
• Recurrent Laryngeal Verrucous Carcinoma
• Recurrent Lip and Oral Cavity Squamous Cell Carcinoma
• Recurrent Metastatic Squamous Cell Carcinoma in the Neck With Occult Primary
• Recurrent Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
• Recurrent Nasopharyngeal Keratinizing Squamous Cell Carcinoma
• Recurrent Oral Cavity Verrucous Carcinoma
• Recurrent Oropharyngeal Squamous Cell Carcinoma
• Recurrent Rectal Carcinoma
• Recurrent Salivary Gland Carcinoma
• Salivary Gland Squamous Cell Carcinoma
• Squamous Cell Carcinoma Metastatic in the Neck With Occult Primary
• Stage IV Hypopharyngeal Squamous Cell Carcinoma AJCC v7
• Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7
• Stage IVA Colon Cancer AJCC v7
• Stage IVA Laryngeal Squamous Cell Carcinoma AJCC v7
• Stage IVA Laryngeal Verrucous Carcinoma AJCC v7
• Stage IVA Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
• Stage IVA Major Salivary Gland Cancer AJCC v7
• Stage IVA Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v7
• Stage IVA Oral Cavity Cancer AJCC v6 and v7
• Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7
• Stage IVA Rectal Cancer AJCC v7
• Stage IVB Colon Cancer AJCC v7
• Stage IVB Laryngeal Squamous Cell Carcinoma AJCC v7
• Stage IVB Laryngeal Verrucous Carcinoma AJCC v7
• Stage IVB Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
• Stage IVB Major Salivary Gland Cancer AJCC v7
• Stage IVB Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v7
• Stage IVB Oral Cavity Cancer AJCC v6 and v7
• Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7
• Stage IVB Rectal Cancer AJCC v7
• Stage IVC Laryngeal Squamous Cell Carcinoma AJCC v7
• Stage IVC Laryngeal Verrucous Carcinoma AJCC v7
• Stage IVC Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
• Stage IVC Major Salivary Gland Cancer AJCC v7
• Stage IVC Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v7
• Stage IVC Oral Cavity Cancer AJCC v6 and v7
• Stage IVC Oropharyngeal Squamous Cell Carcinoma AJCC v7
• Tongue Carcinoma

Interventions

BIOLOGICAL

Cetuximab

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Lenalidomide

Given PO

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Erin M Bertino · Ohio State University Comprehensive Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-02-10

Primary Completion

2014-01-29

Completion

2014-01-29

Countries

• United States

Study Locations