Gemcitabine and Docetaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Intervention: docetaxel; Gemcitabine
Intervention description: Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.; Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.
Intervention MeSH terms: Gemcitabine; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the hypopharynx; recurrent squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the larynx; recurrent squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the lip and oral cavity; metastatic squamous neck cancer with occult primary squamous cell carcinoma; recurrent metastatic squamous neck cancer with occult primary; recurrent squamous cell carcinoma of the nasopharynx; stage IV squamous cell carcinoma of the nasopharynx; recurrent squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx; recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity; stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity

Summary:

      RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, 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 docetaxel
      works in treating patients with persistent, recurrent, or metastatic head and neck cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed squamous cell carcinoma of the head and neck

          -  Metastatic, persistent, or recurrent disease

          -  Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
             conventional techniques OR ≥ 10 mm by spiral CT scan

          -  Must have had definitive surgery and/or radiation therapy AND received at least 1, but
             no more than 2, chemotherapy regimens, either given as primary therapy or adjuvant
             therapy before or after surgery and/or radiotherapy

          -  No active or prior CNS metastasis

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  SWOG 0-2

        Life expectancy

          -  At least 12 weeks

        Hematopoietic

          -  Granulocyte count > 1,500/mm^3

          -  Hemoglobin ≥ 8 g/dL

          -  Platelet count > 100,000/mm^3

        Hepatic

          -  Bilirubin normal

          -  Meets 1 of the following criteria:

               -  Alkaline phosphatase (AP) normal AND AST or ALT ≤ 5 times upper limit of normal
                  (ULN)

               -  AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN

               -  AP ≤ 5 times ULN AND AST or ALT normal

        Renal

          -  Creatinine < 1.5 mg/dL

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for ≥ 3 months after
             completion of study treatment

          -  No peripheral neuropathy ≥ grade 2

          -  No active infection requiring systemic therapy

          -  No other malignancy within the past 5 years except adequately treated basal cell or
             squamous cell skin cancer or carcinoma in situ of the cervix or any other site

          -  No history of severe hypersensitivity reaction to study drugs or other drugs
             formulated with polysorbate 80

          -  No other serious condition that would preclude study treatment

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  See Disease Characteristics

          -  No prior taxane or gemcitabine

          -  At least 4 weeks since prior chemotherapy and recovered

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  See Disease Characteristics

          -  At least 4 weeks since prior radiotherapy and recovered

        Surgery

          -  See Disease Characteristics

        Other

          -  No other concurrent therapy for this disease