Phase II Study of Biweekly Gemcitabine and Paclitaxel (GEMTAX) Combination in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Pts must have histologically or cytologically proven SCCHN that is either met or persisted or recurred following definitive surg and/or RT. Pts must not have rec'd prior chemo for recurrent or newly diagnosed met dz. Pts who have rec'd induction or adjuvant chemo are eligible provided at least 6 mos has elapsed since last course of chemo was administered. Pts may have rec'd only one induction or adjuvant regimen. Pts must not have rec'd prior gemcitabine or taxanes as part of induction, adjuvant, or neoadjuvant chemotherapy. Prior RT must have been completed at least 28 days prior to reg & all toxicites resolved. May have measurable dz or non measurable dz. All dz must be assessed w/i 28 days prior to reg. All non-measurable dz, must be assessed w/i 42 days prior to reg. Must not be planning to rec other therapy for SCHHN while on study. PS 0 -1. Pts with active infection requiring systemic therapy or pts with active or prior CNS metastasis are excluded. Pts must not have serious organ dysfunction or other serious co-morbid conditions that might affect the tolerance of chemotherapy. Pts w/ hz of hypersensitivity reaction to products containing Polysorbate 80 are not eligible. Pts must have less than Grade 2 symptomatic neuropathy-sensory. Must not be pregnant or nursing; women/men of reproductive potential must agree to use an effective contraceptive method.