Docetaxel, Cetuximab and Cisplatin Followed by Radiation, Cetuximab and Cisplatin in Head and Neck Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00226239
• Date of registration: 22/09/2005
• Primary sponsor: University of Pittsburgh
• Public title: Docetaxel, Cetuximab and Cisplatin Followed by Radiation, Cetuximab and Cisplatin in Head and Neck Cancer
• Scientific title: A Phase II Trial of Docetaxel, Cetuximab (C225), and Cisplatin Followed by Radiation, Cetuximab, and Cisplatin in Locally Advanced Head and Neck Cancer
• Date of first enrolment: October 2005
• Target sample size: 40
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00226239
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Michael Gibson, MD
• Affiliation: University of Pittsburgh

Key inclusion & exclusion criteria

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
years

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
disease

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Cancer

Intervention(s)

Drug: Cetuximab

Drug: Cisplatin

Drug: Docetaxel

Procedure: Radiation Therapy

Primary Outcome(s)

To evaluate the objective response rate with induction with cisplatin/docetaxel/cetuximab in subjects. [Time Frame: 10 years]

Secondary Outcome(s)

To evaluate the toxicities, objective response rate post chemoradiotherapy, time to progression, overall survival, local and distant failure rates. [Time Frame: 10 years]

Secondary ID(s)

05-003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bristol-Myers Squibb