NCT01696955

Cetuximab With or Without Tivantinib in Treating Patients With Head and Neck Cancer That Is Recurrent, Metastatic, or Cannot Be Removed by Surgery

A Randomized Phase II Trial of ARQ 197 (Tivantinib)/Cetuximab Versus Cetuximab in Patients With Recurrent/Metastatic Head and Neck Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase II trial studies how well cetuximab with or without tivantinib works in treating patients with head and neck cancer that has come back (recurrent), has spread to other places in the body (metastatic), or cannot be removed by surgery. Monoclonal antibodies, such as cetuximab, may interfere with the ability of tumor cells to grow and spread. Tivantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether cetuximab is more effective with or without tivantinib in treating patients with head and neck cancer.

Detailed description

PRIMARY OBJECTIVES: I. Response rate (comparing the cetuximab/ARQ 197 \[tivantinib\] combination with cetuximab single agent activity). SECONDARY OBJECTIVES: I. Continuous tumor shrinkage. II. Progression-free survival (PFS). III. Overall survival (OS). IV. Objectives I, II, and III above, as well as response rates, will be assessed and compared between treatment arms in the subgroup of patients with high mesenchymal epithelial transition factor (c-MET) expression, and/or high c-MET copy number. V. Single agent activity for ARQ 197 (tivantinib) in patients who have failed cetuximab. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive cetuximab intravenously (IV) over 60-120 minutes on days 1 and 15 and tivantinib orally (PO) twice daily (BID) on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive cetuximab IV over 60-120 minutes on days 1 and 15. Patients who fail cetuximab as a single agent may receive single agent tivantinib PO BID on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 5 years.

Conditions

• Head and Neck Squamous Cell Carcinoma
• Recurrent Head and Neck Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Cetuximab	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Tivantinib	Given PO

Timeline

• Start date: 2012-08-20
• Primary completion: 2017-05-05
• Completion: 2017-05-05
• First posted: 2012-10-02
• Last updated: 2018-12-19
• Results posted: 2018-12-19

Locations

24 sites across 1 country: United States