Conditions: Head and Neck Cancer Colon Cancer
Keywords: Head and Neck Colon
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 23
Healthy volunteers: no

Brief 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

Arms:
arm 1: Cetuximab, 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly there after Eribulin Mesylate 1.4mg/m2 arm 2: Eribulin Mesylate:

1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle

Interventions: intervention 1: Head and neck intervention 2: Colon- Closed as of May 2014
Intervention descriptions: intervention 1: 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 intervention 2: Eribulin Mesylate:

1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle

Protocol document: