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Clinical Trial 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.


Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine the maximum-tolerated dose of lenalidomide when given in combination with cetuximab in patients with advanced colorectal or squamous cell head and neck cancer.

SECONDARY OBJECTIVES:

I. To evaluate response in refractory V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) wild-type colorectal and head/neck cancers as monitored by measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST) criteria.

II. To measure antibody-dependent cytotoxic activity (ADCC) in patients receiving lenalidomide plus cetuximab.

III. To measure natural killer cell cytokine production in patients receiving lenalidomide plus cetuximab.

IV. To describe fragment c gamma receptor polymorphisms. (Exploratory) V. To describe baseline immune cell function. (Exploratory)

OUTLINE: This is a dose-escalation study of lenalidomide.

Patients receive lenalidomide orally (PO) once daily (QD) on days 1-21 and cetuximab intravenously (IV) over 1-2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 6 weeks. ;


Study Design


Related Conditions & MeSH terms

  • Carcinoma
  • Carcinoma, Squamous Cell
  • Colonic Neoplasms
  • Mouth Neoplasms
  • Rectal Neoplasms
  • 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 Neoplasms
  • 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

NCT number NCT01254617
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 1
Start date February 10, 2011
Completion date January 29, 2014

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