S0329, Gemcitabine and Paclitaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Intervention: gemcitabine; paclitaxel
Intervention description: 3,000 mg/m2 IV over 30 minutes on days 1 and 15 (q28 days).; 150 mg/m2 IV over 1 hour on days 1 and 15 (q 28 day cycle), administered after gemcitabine
Intervention MeSH terms: Paclitaxel; Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 67.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Recurrent; stage IV; squamous cell carcinoma; hypopharynx; larynx; lip; oral cavity; nasopharynx; oropharynx; paranasal; nasal cavity; metastatic; neck cancer

Summary:

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

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed squamous cell carcinoma of the head and neck
             (SCCHN)

               -  Recurrent, persistent, or newly diagnosed metastatic disease

          -  Measurable or non-measurable disease

          -  No active or prior CNS metastasis

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  Zubrod 0-1

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Not specified

        Hepatic

          -  Not specified

        Renal

          -  Not specified

        Other

          -  No serious organ dysfunction

          -  No serious comorbid conditions that would preclude study treatment

          -  No history of hypersensitivity reaction to products containing polysorbate 80

          -  No active infection requiring systemic antibiotic therapy

          -  No symptomatic sensory neuropathy ≥ grade 2

          -  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

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No concurrent biologic or immunotherapy for SCCHN

          -  No concurrent gene therapy for SCCHN

        Chemotherapy

          -  No prior chemotherapy for recurrent or newly diagnosed metastatic disease

          -  At least 6 months since prior induction or adjuvant chemotherapy

               -  No more than 1 prior induction or adjuvant regimen

          -  No prior gemcitabine or taxanes as part of induction, adjuvant, or neoadjuvant
             chemotherapy

          -  No other concurrent chemotherapy for SCCHN

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  At least 28 days since prior radiotherapy and recovered

          -  No concurrent radiotherapy for SCCHN

        Surgery

          -  Not specified

        Other

          -  No other concurrent therapy for SCCHN