Overview

Trial of 2 Cycles of Induction Chemo With Abraxane, Cetuximab, Cisplatin, & 5-FU for Advanced Head and Neck Cancer

Status:
Completed
Trial end date:
2020-07-06
Target enrollment:
0
Participant gender:
All
Summary
This phase two trial will determine the tumor response rate at the primary site and at involved regional nodes to two cycles of an IC regimen of weekly Abraxane and cetuximab given in combination with cisplatin and 5-FU in patients with local regionally advanced HNSCC.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Washington University School of Medicine
Collaborator:
Celgene Corporation
Treatments:
Albumin-Bound Paclitaxel
Cetuximab
Cisplatin
Paclitaxel
Criteria
Inclusion

- Selected Stages 3 and 4a/b HNSCC: All patients must have T2-T4 primary tumors.
Patients with T1 tumors will be excluded. Although most of these patients will have
regional nodal disease, patients with no nodal disease will also be eligible.

- Oropharynx, hypopharynx, larynx, and oral cavity sub-sites only. Patients with
nasopharyngeal, sinus and other sub-sites of the head and neck, or unknown primary SCC
of the head and neck will NOT be eligible.

- Age ≥18 years

- Signed informed consent.

- ECOG Performance Status (PS) of 0-2 (Appendix 1).

- Adequate vital organ function (serum creatinine < 1.8 mg/dl, total bilirubin mg/dl, ALT and AST hematopoietic function (ANC >/= 1500/ul, Platelets > 100,000/ul, HGB > 9.0 g/dl).

- Patients with reproductive potential must use an effective method of contraception to
avoid pregnancy for the duration of the trial and for three months after completing
treatment.

- If female of childbearing potential, the patient must have a negative pregnancy test.

Exclusion Criteria:

- Peripheral neuropathy > Grade 1.

- Prior chemotherapy, EGFR targeted therapy or radiation therapy for HNSCC.

- History of prior invasive malignancy diagnosed within the last three years other than
local stage non-melanoma skin cancer.

- Be taking cimetidine or allopurinol. Patients must discontinue taking the medication
for one week before receiving treatment with Abraxane.

- Be taking cimetidine or allopurinol. Patients must discontinue taking the medication
for one week before receiving treatment with Abraxane.