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A Randomized Phase II Trial of Concurrent Chemoradiation With Cetuximab (ERBITUX®), 5 Fluorouracil, Hydroxyurea, and Twice-daily Radiation (CetuxFHX) Versus Cetuximab (ERBITUX®), Cisplatin, and Accelerated Radiation With Concomitant Boost (CetuxPX) After Induction Chemotherapy in Patients With Locally Advanced Head and Neck Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

Thank you

Trial Information

A Randomized Phase II Trial of Concurrent Chemoradiation With Cetuximab (ERBITUX®), 5 Fluorouracil, Hydroxyurea, and Twice-daily Radiation (CetuxFHX) Versus Cetuximab (ERBITUX®), Cisplatin, and Accelerated Radiation With Concomitant Boost (CetuxPX) After Induction Chemotherapy in Patients With Locally Advanced Head and Neck Cancer


Inclusion Criteria:



- Age 18 or older

- Stage III and IV head and neck cancer

- Patients with squamous cell carcinoma of unknown primary and suspected origin in the
head and neck area

- No prior chemotherapy or radiotherapy

- Prior surgical therapy of incisional or excisional biopsy and organ-sparing
procedures only

- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2

- Normal organ and marrow function

Exclusion Criteria:

- Unequivocal demonstration of metastatic disease

- Known severe hypersensitivity to drugs used in the study

- Treatment with a non-approved or investigational drug within 30 days before Day 1

- Incomplete healing from previous surgery

- Pregnancy or breast feeding

- Uncontrolled intercurrent illness including

- Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any
history of clinically significant CHF

- Acute hepatitis or known HIV

- Severe baseline neurologic deficits

- Prior therapy which specifically and directly targets the EGFR pathway

- Prior severe infusion reaction to a monoclonal antibody

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression free survival (PFS) and overall survival (OS)

Outcome Time Frame:

1-year and 2-year progression free survival as well as overall survival

Safety Issue:

No

Principal Investigator

Everett E Vokes, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago

Authority:

United States: Institutional Review Board

Study ID:

14401A

NCT ID:

NCT00468169

Start Date:

July 2006

Completion Date:

November 2012

Related Keywords:

  • Head and Neck Cancer
  • Cetuximab
  • Erbitux
  • locally
  • advanced
  • head
  • neck
  • cancer
  • neoplasms
  • squamous
  • carcinoma
  • lymphoepithelioma
  • Head and Neck Neoplasms

Name

Location

University of ChicagoChicago, Illinois  60637