NCT01744340

A Dose Finding Study of Eribulin Mesylate and Cetuximab For Patients With Advanced Head and Neck and Colon Cancer

A Dose Finding Study of Eribulin Mesylate and Cetuximab For Patients With Advanced Head and Neck and Colon Cancer With an Expansion Cohort For Head and Neck Cancer: A Brown University Oncology Research Group Study

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: howard safran · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if the full dose of eribulin mesylate can be safely given with the full dose of cetuximab. The activity of the combination of eribulin mesylate and cetuximab on recurrent head and neck cancer and colon cancer will also be assessed.

Detailed description

To determine if eribulin mesylate, up to a maximum dose of 1.4 mg/m2 day 1 and 8 of a 21 day cycle, can be safely combined with full dose cetuximab for patients with advanced head and neck cancer and colon cancer

Conditions

• Head and Neck Cancer
• Colon Cancer

Interventions

Type	Name	Description
DRUG	Head and neck	Eribulin mesylate is administered by IV infusion over 2-5 minutes on day 1 and 8 of a 21 day cycle 1.4mg/m2 and Cetuximab 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly thereafter Dose Level 1: 0.7 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 2: 1.0 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 3: 1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle
DRUG	Colon- Closed as of May 2014	Eribulin Mesylate: 1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle

Timeline

• Start date: 2012-05-01
• Primary completion: 2015-03-01
• Completion: 2015-07-01
• First posted: 2012-12-06
• Last updated: 2020-02-17
• Results posted: 2016-02-10

Locations

4 sites across 1 country: United States