Neoplasms

All Conditions

Symptoms and General Pathology

Carcinoma, Squamous Cell

Recurrence

Neoplasms, Squamous Cell

Carcinoma

Disease Attributes

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

Antiemetics

Gastrointestinal Agents

Emetics

Cetuximab

Antineoplastic Agents, Immunological

Cetuximab will be administered at 500 mg/m\^2 intravenously every other week. Cabozantinib will be initiated at 40 mg PO daily, with subsequent 20 mg or 40 mg doses as tolerated per the study design.

Cabozantinib will be initiated at 40 mg PO daily, with subsequent 20 mg or 40 mg doses as tolerated per the study design.

Cabozantinib

Cetuximab will be administered at 500 mg/m\^2 intravenously every other week on Days 1 and 15 of each cycle, with a window of up to 3 days before the scheduled date. In an effort to prevent a hypersensitivity reaction, it is recommended that all patients pre-medications, hydration, and anti-emetics will be given according to institutional guidelines and/or per treating physician discretion.

Loren Michel, MD

The purpose of this study is to test the safety of cabozantinib, at different doses, in combination with cetuximab to find out what effects, if any, this combined treatment has on people with HNSCC.

A standard 3+3 design will be used to find the maximum tolerated dose (MTD) from 3 testing dose levels: 20, 40, and 60.

Cabozantinib in Combination With Cetuximab in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Cancer

A Phase 1 Study of Concurrent Cabozantinib and Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Cancer

from 3 testing dose levels: 20, 40, and 60. Three patients will be enrolled at the dose level 0 of 40 mg. The dose escalation scheme is as follows:

1. If none of the initial three patients at a given dose level experience DLT within 4 weeks, the next dose level will be studied.
2. If one of the initial three patients at a given dose level experiences DLT, three additional patients will be treated at the same dose level. Escalation will continue only if there is no additional DLT observed.If two or more patients experience DLT at a given dose, the previous dose level will be studied. Should two or more patients experience the DLT at the lowest dose level (20 mg), the study will be halted, and alternative dosing will be considered.

4. The highest dose level with no more than one DLT among six patients will be declared as the MTD. If only three patients were treated at a dose under consideration as the MTD, an additional three patients will be treated at that level.

Spots Global Cancer Trial Database for metastatic head and neck squamous cell cancer