Docetaxel, Cetuximab and Cisplatin Followed by Radiation, Cetuximab and Cisplatin in Head and Neck Cancer
Condition: Cancer
MeSH terms: Head and Neck Neoplasms
Intervention: Docetaxel; Cisplatin; Cetuximab; Radiation Therapy
Intervention description: Docetaxel 75 mg/m^2 IV over 1 hour, day 1; Cisplatin 75 mg/m^2 IV over 1-2 hours, day 1, 1 hour following completion of cetuximab infusion.; Cetuximab dose will be 250 mg/m^2 IV over 60 minutes weekly on ALL subsequent administrations (days 8 and 15 of cycle 1 and days 1,8,15 of cycles 2 and 3).; Photon energies of 1.25 to 6 MV and/or appropriate electron energies for boosting the nodes are allowed. Photon energies>6 MV may be utilized when appropriate to boost target localized centrally.
Intervention MeSH terms: Docetaxel; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: head; neck

Summary:

      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.
    

Eligibility 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.