PRIMARY OBJECTIVES:
I. To estimate whether topical cryotherapy can alleviate paclitaxel-induced peripheral neuropathy.
II. To estimate whether topical cryotherapy can alleviate paclitaxel-induced acute pain syndrome (P-APS).
III. To examine the possible relative toxicities related to topical cryotherapy in this study situation.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients apply bags filled with crushed ice to hands and feet for 15 minutes before, for 60 minutes during administration, and for 15 minutes after finishing administration of paclitaxel.
ARM II: Patients receive paclitaxel intravenously (IV) over 60 minutes on weeks 1-12.
In both arms, courses repeat once a week for 12 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 30 days for 6 months.