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Claims for Patent: 5,641,803

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Claims for Patent: 5,641,803

Title: Methods for administration of taxol
Abstract:Taxol dosages of about 135 mg/m.sup.2 or greater are administered via infusions of less than 6 hours duration; the method makes it possible to provide taxol infusions on an out-patient basis to patients who do not otherwise require hospitalization. In a preferred embodiment, about 135 mg/m.sup.2 of taxol in a cremaphor emulsion is infused over a 3 hour duration, following patient pretreatment with steroids, antihistamines, and H.sub.2 -receptor antagonists sufficient to prevent fatal anaphylactic-like reactions, and preferably sufficient to reduce the occurrence of severe anaphylactic-like reactions in greater than 90% of patients treated. In an alternative embodiment, between 135 mg/.sup.2 and about 175 mg/m.sup.2 of taxol is provided in a 3-hour infusion, following protreatment to minimize hypersensitivity responses. A method for rechallenging patients with taxol after episodes of acute hypersensitivity reactions is also disclosed, thus enabling patients to continue taxol therapy who would otherwise be deprived of treatment.
Inventor(s): Carretta; Renzo Mauro (Madison, CT), Eisenhauer; Elizabeth (Kingston, CA), Rozencweig; Marcel (Spendford, CT)
Assignee: Bristol-Myers Squibb Company (Princeton, NJ)
Application Number:08/544,594
Patent Claims: 1. A method for reducing hematologic toxicity in a cancer patient undergoing Taxol treatment comprising parenterally administering to said patient an antineoplastically effective amount of about 135-175 mg/m.sup.2 taxol over a period of about three hours.

2. A method for reducing both hematologic toxicity and neurotoxicity in a cancer patient undergoing Taxol treatment comprising parenterally administering to said patient an antineoplastically effective amount of about 135 mg/m.sup.2 taxol over a period of about three hours.

3. The method of claim 2, wherein said patient is suffering from solid tumors or leukemias.

4. A method for reducing hematologic toxicity in patients suffering from ovarian cancer and undergoing Taxol treatment for such cancer comprising parenterally administering an antineoplastically effective amount of about 135-175 mg/m.sup.2 taxol over a period of about three hours.

5. A method for reducing both hematologic toxicity and neurotoxicity in a patient suffering from ovarian cancer and undergoing Taxol treatment comprising parenterally administering to said patient an antineoplastically effective amount of about 135 mg/.sup.2 taxol over a duration of about three hours.

6. The method of claim 1, wherein said patient is suffering from solid tumors or leukemias.
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