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

University of Pittsburgh

Status and phase: Completed; Phase 2

Conditions: Cancer

Treatments: Drug: Cisplatin; Procedure: Radiation Therapy; Drug: Cetuximab; Drug: Docetaxel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00226239

05-003

Details and patient eligibility

About

The purpose of this study is to determine if the addition of a unique targeted agent called Cetuximab (also known as "C225" and "Erbitux") can increase the effectiveness of standard treatment with chemotherapy and radiation.

Full description

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 future.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

Head and neck cancer patients

Experimental group

Description:

Induction chemotherapy consists of 3 cycles of cisplatin 75 mg/m\^2, on day 1, docetaxel 75 mg/m\^2, on day 1, and cetuximab weekly days 1,8,15, repeated every 21 days (cetuximab dose is 400 mg/m\^2 on day 1 and 250 mg/m\^2 on subsequent weekly treatments). After 3 cycles of induction, patients receive standard radiation 70 Gy/200 cGy/daily, 5 days/week with concurrent weekly cisplatin 30 mg/m\^2 and cetuximab 250 mg/m\^2. After completing radiation therapy, patients receive cetuximab weekly as maintenance therapy for 6 months (see section 5 for detailed treatment plan and dose modifications)

Treatment:

Drug: Cetuximab

Drug: Docetaxel

Procedure: Radiation Therapy

Drug: Cisplatin