Phase II Evaluation of E7389 (NSC-707389) in Patients with Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck

Pts must have histologically or cytologically proven SCCHN (excluding salivary and nasopharyngeal primaries) 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. who have rec'd prior biologic therapy are eligible provided last dose was at least 2 wks. prior to reg. Prior RT must have been completed at least 28 days prior to reg & all toxicites resolved. Must have measurable dz. All meas 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. Normal organ function. Pts with active or prior CNS metastasis are excluded. Pts known to be HIV + and on combo antiretrovirals ar ineligible. Must not be pregnant or nursing; women/men of reproductive potential must agree to use an effective contraceptive method.