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A Phase II Trial of Docetaxel, Cetuximab (C225), and Cisplatin Followed by Radiation, Cetuximab, and Cisplatin in Locally Advanced Head and Neck Cancer

Phase 2
18 Years
Open (Enrolling)

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Trial Information

A Phase II Trial of Docetaxel, Cetuximab (C225), and Cisplatin Followed by Radiation, Cetuximab, and Cisplatin in Locally Advanced Head and Neck Cancer

This research study involves the use of a combination of two chemotherapies, cisplatin and
docetaxel, which have been known to shrink head and neck cancers and are a commonly used
treatment for this type of cancer. This combination will then be followed by radiation and
more chemotherapy.

The purpose of this study is to see whether this combination of chemotherapy and radiation,
with the addition of Cetuximab, can improve control of disease and collect information on
what side effects this combination therapy may have. In addition, biologic factors (markers)
will be studied that may help to predict and treat head and neck cancer patients in the

Inclusion Criteria:

1. Stage III-IVB head and neck cancer, all sites, including unknown primary tumors
(bulky stage II (T2N0) lesions of the base of tongue or hypopharynx and patients with
stage II nasopharyngeal cancer are also eligible) Prior to study entry the
resectability and alternative treatment options will be determined by a team composed
of an Ear, Nose, and Throat Surgeon, a Radiation Oncologist and a Medical Oncologist.
Stage determination, optimal local treatment, and its timing according to this
protocol will be determined at this evaluation. Unequivocal demonstration of distant
metastasis (M1) confers ineligibility

2. Histologically or cytologically confirmed diagnosis of squamous cell or poorly
differentiated carcinomas, or WHO types I-III of the nasopharynx

3. Unidimensionally-measurable disease is required (RECIST)

4. No prior chemotherapy, biologic/molecular targeted therapy (including any prior
therapy which specifically and directly targets the EGFR pathway), or radiotherapy
for head and neck cancer

5. Prior surgical therapy will consist only of incisional or excisional biopsy and organ
sparing procedures such as debulking of airway compromising tumors or neck dissection
in a patient with an existing primary tumor (Any non-biopsy procedure must have taken
place > 4 weeks but < 3 months of initiating protocol treatment)

6. ECOG PS 0 or 1; 7. Organ & marrow function per protocol criteria and 8. Age of >=18

Exclusion Criteria:

1. History of severe allergic reactions attributed to docetaxel or compounds of similar
chemical or biologic composition to docetaxel, or other drugs formulated with
polysorbate 80

2. Uncontrolled intercurrent illness or significant history of uncontrolled cardiac

3. Receiving any other investigational agents

4. No history of prior malignancy, with the exception of curatively treated squamous
cell or basal carcinoma of the skin or in situ cervical cancer, or malignancy that
has been treated with a curative intent with a 5-year disease-free survival

5. Significant baseline sensory or motor neurologic deficits (> grade I neuropathy); 6.
HIV-positive patients and 7. Prior severe infusion reaction to a monoclonal antibody.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the objective response rate with induction with cisplatin/docetaxel/cetuximab in subjects.

Outcome Time Frame:

10 years

Safety Issue:


Principal Investigator

Michael Gibson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh


United States: Food and Drug Administration

Study ID:




Start Date:

October 2005

Completion Date:

December 2015

Related Keywords:

  • Cancer
  • head
  • neck
  • Head and Neck Neoplasms



University of Pittsburgh Medical Center Pittsburgh, Pennsylvania  15213