Gemcitabine and Doxorubicin in Treating Patients With Recurrent or Progressive Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Intervention: doxorubicin hydrochloride; gemcitabine hydrochloride
Intervention description: given as 25mgm2 IV on days 1 and 8 of each 21-day cycle.; given as 100mg/m2 IV over days 1 and 8 of each 21 day cycle
Intervention MeSH terms: Gemcitabine; Doxorubicin; Liposomal doxorubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent squamous cell carcinoma of the hypopharynx; recurrent squamous cell carcinoma of the larynx; recurrent verrucous carcinoma of the larynx; recurrent adenoid cystic carcinoma of the oral cavity; recurrent basal cell carcinoma of the lip; recurrent mucoepidermoid carcinoma of the oral cavity; recurrent squamous cell carcinoma of the lip and oral cavity; recurrent verrucous carcinoma of the oral cavity; recurrent metastatic squamous neck cancer with occult primary; recurrent lymphoepithelioma of the nasopharynx; recurrent squamous cell carcinoma of the nasopharynx; recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity; recurrent inverted papilloma of the paranasal sinus and nasal cavity; recurrent midline lethal granuloma of the paranasal sinus and nasal cavity; recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity; recurrent salivary gland cancer; recurrent lymphoepithelioma of the oropharynx; recurrent squamous cell carcinoma of the oropharynx

Summary:

      RATIONALE: Drugs used in chemotherapy, such as gemcitabine and doxorubicin, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving gemcitabine together with
      doxorubicin works in treating patients with recurrent or progressive head and neck cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

        Inclusion criteria:

          -  Histologically or cytologically confirmed head and neck cancer

               -  Recurrent or progressive disease

          -  Must have measurable disease, defined as at least one lesion that can be accurately
             measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm by
             conventional techniques or as ≥ 10 mm by spiral CT scan

          -  Must have received prior platinum-based chemotherapy regimen (cisplatin or
             carboplatin) with or without radiotherapy, unless the patient was deemed unsuitable
             for platinum-based therapy due to renal dysfunction or other clinical contraindication

        Exclusion criteria:

          -  Known brain metastases

        PATIENT CHARACTERISTICS:

        Inclusion criteria:

          -  ECOG performance status (PS) ≤ 2 OR Karnofsky PS ≥ 60%

          -  Absolute neutrophil count ≥ 1,500/μL

          -  Platelets ≥ 100,000/µL

          -  Total bilirubin ≤ 1.5 mg/dL

          -  AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal

          -  Creatinine ≤ 2 mg/dL OR creatinine clearance ≥ 30 mL/min

          -  Females of reproductive potential must not plan on conceiving children during study
             treatment period and must agree to use adequate contraception (hormonal or barrier
             method of birth control or abstinence) prior to study entry and for the duration of
             the study

        Exclusion criteria:

          -  Not pregnant or breastfeeding

          -  History of allergic reaction attributed to compounds of similar chemical or biological
             composition to gemcitabine hydrochloride or doxorubicin hydrochloride

          -  Lower than normal cardiac ejection fraction

               -  Patients must have an echocardiogram or MUGA scan prior to the use of study drugs

          -  Uncontrolled intercurrent illness that would limit compliance with study requirements
             including, but not limited to, any of the following:

               -  Ongoing or active infection

               -  Symptomatic congestive heart failure

               -  Unstable angina pectoris

               -  Cardiac arrhythmia

               -  Psychiatric illness or social situation

          -  Clinical AIDS or known positive HIV serology

        PRIOR CONCURRENT THERAPY:

        Inclusion criteria:

          -  Recovered from prior therapy

          -  At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)

          -  At least 30 days since prior experimental agents

          -  At least 4 weeks since prior radiotherapy for palliation or for the primary tumor

        Exclusion criteria:

          -  Prior gemcitabine hydrochloride or doxorubicin hydrochloride

          -  Concurrent hormones or other chemotherapeutic agents, except for steroids given for
             adrenal failure, hormones given for non-disease-related conditions (e.g., insulin for
             diabetes), or intermittent use of dexamethasone as an antiemetic

          -  Concurrent palliative radiotherapy

          -  Other concurrent investigational or commercial agents or therapies