Docetaxel Based Chemotherapy Plus or Minus Induction Chemotherapy to Decrease Events in Head and Neck Cancer (DeCIDE)
Condition: Cancer of the Pharynx; Cancer of the Larynx; Cancer of the Nasal Cavity; Paranasal Sinus Neoplasms; Cancer of the Oral Cavity
MeSH terms: Head and Neck Neoplasms; Laryngeal Neoplasms; Paranasal Sinus Neoplasms; Pharyngeal Neoplasms
Intervention: docetaxel; cisplatin; hydroxyurea; fluorouracil; chemotherapy; radiotherapy
Intervention description: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase); 75 mg/m2 on day 1; Each cycle: 500 mg PO q 12 hours x 6 days (11 doses); 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase); See protocol for details; See protocol for details
Intervention MeSH terms: Docetaxel; Fluorouracil; Hydroxyurea
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 285.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cancer of the Pharynx (Nasopharynx, Oropharynx, Hypopharynx); Cancer of the Nasal Cavity and Paranasal Sinuses

Summary:

      The combined use of chemotherapeutic drugs with radiation has proven to be effective in
      improving overall survival and local control among patients with locally advanced head and
      neck cancer. Induction chemotherapy given before receiving local treatment has been shown to
      reduce the rate of distant failure. Many drugs have been found to prevent tumor cells from
      growing or dividing, although it has yet to be determined which agent, or specific
      combination of agents, is most effective in treating head and neck cancer. Docetaxel is a
      drug which has been reported to show promising activity in Phase II head and neck cancer
      studies. Therefore, the purpose of this trial is to compare the effectiveness of induction
      chemotherapy followed by chemoradiotherapy versus the same chemoradiotherapy alone in
      patients with locally advanced head and neck cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years or older

          -  Histologically or cytologically confirmed diagnosis of squamous cell or poorly
             differentiated carcinomas of the head and neck (excluding lip), or lymphoepithelioma

          -  No prior chemotherapy or radiotherapy

          -  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

          -  Karnofsky performance status of >= 70%

          -  Intact organ and bone marrow function

          -  Obtained informed consent

        Exclusion Criteria:

          -  Demonstration of metastatic disease (i.e. M1 disease).

          -  Patients with a history of severe allergic reaction to docetaxel or other drugs
             formulated with polysorbate 80. History of allergic reactions attributed to compounds
             of similar chemical or biologic composition to cisplatin, 5-fluorouracil, or
             hydroxyurea

          -  Other coexisting malignancies or malignancies diagnosed within the previous 3 years
             with the exception of basal cell carcinoma, cervical cancer in situ, and other treated
             malignancies with no evidence of disease for at least 3 years.

          -  Prior surgical therapy other than incisional or excisional biopsy and organ-sparing
             procedures such as debulking of airway-compromising tumors or neck dissection in a
             patient with an unknown primary tumor. Any non-biopsy procedure must have taken place
             less than 3 months from initiating protocol treatment.

          -  Incomplete healing from previous surgery

          -  Pregnancy or breast feeding (men and women of child-bearing potential are eligible but
             must consent to using effective contraception during therapy and for at least 3 months
             after completing therapy)

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure (CHF), unstable angina pectoris,
             cardiac arrhythmia, or psychiatric illness/social situations that would limit
             compliance with study requirements

          -  Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any
             history of clinically significant CHF are excluded. The exclusion of patients with
             active coronary artery disease will be at the discretion of the attending physician.

          -  Uncontrolled active infection unless curable with treatment of their cancer.