Azacitidine and Cisplatin for Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Condition: Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Intervention: Azacitidine; Cisplatin
Intervention description: SC azacitidine; cisplatin 75 mg/m^2 day 8 every 28 days
Intervention MeSH terms: Azacitidine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Head and Neck Cancer

Summary:

      To evaluate the safety and toxicity of azacitidine (5-azacitidine, Vidaza®) and cisplatin
      combination in patients with squamous cell carcinoma of head and neck (SCCHN).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically proven SCCHN that is either metastatic or has
             persisted or recurred following definitive surgery and/or radiation therapy, and is
             not amenable to salvage surgical resection.

          -  Patients may have received previous chemotherapy and/or biological treatment (such as
             cetuximab) for the recurrent or metastatic disease. Prior treatment must have been
             completed at least 28 days (42 days for nitrosoureas or mitomycin C) prior to entering
             the study and all toxicities must have been resolved.

          -  Prior radiation must have been completed at least 28 days before entry into the study
             and all toxicities must have been resolved (no more than 3000 cGy to fields including
             substantial marrow).

          -  Surgery must have been completed at least 28 days before entry into the study and all
             complications/adverse events must have been resolved.

          -  Patients must have at least one lesion amenable to serial biopsy.

          -  Age greater than 18 years.

          -  ECOG performance status less than 2 (Karnofsky greater than 60%).

          -  Life expectancy of greater than 3 months.

          -  Patients must have normal organ and marrow function

          -  Patients must not be planning to receive any other concurrent therapy (ie, radiation,
             chemotherapy, immunotherapy, biological therapy or gene therapy) for SCCHN while they
             are on this study.

          -  Women of childbearing potential must have a negative serum pregnancy test prior to
             azacitidine treatment.

        Exclusion Criteria:

          -  Patients must not be planning to receive any other concurrent therapy (ie, radiation,
             chemotherapy, immunotherapy, biological therapy, investigational agents or gene
             therapy) for SCCHN while they are on this study.

          -  Patients with known brain metastases should be excluded from this clinical trial
             because of their poor prognosis and because they often develop progressive neurologic
             dysfunction that would confound the evaluation of neurologic and other adverse events.

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to azacitidine, cisplatin and mannitol or other agents used in study.

          -  Pregnant or nursing women may not participate in this trial because of the increased
             risk of fetal harm including fetal death from the chemotherapeutic agents. Women/men
             of reproductive potential may not participate unless they have agreed to use an
             effective contraceptive method.

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements.

          -  Patients known to be HIV-positive are not eligible because of the potential to
             confound this study's endpoints.

          -  No prior malignancy is allowed except for adequately treated basal cell (or squamous
             cell) skin cancer, in situ cervical cancer or other cancer for which the patient has
             been disease-free for five years.