Claims for Patent: 5,670,537

Summary for Patent: 5,670,537

Title:	Method for effecting tumor regression with a low dose, short infusion taxol regimen
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/m.sup.2 and about 175 mg/m.sup.2 of taxol is provided in a 3-hour infusion, following pretreatment 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):	Canetta; Renzo Mauro (Madison, CT), Eisenhauer; Elizabeth (Kingston, CA), Rozencweig; Marcel (Brandford, CT)
Assignee:	Bristol-Meyers Squibb Company (Princeton, NJ)
Application Number:	08/715,914
Patent Claims:	1. A method for treating a patient suffering from a taxol-sensitive tumor comprising (i) premedicating said patient with a medicament that reduces or eliminates hypersensitivity reactions, and (ii) parenterally administering to said patient about 135-175 mg/m.sup.2 taxol over about three hours. 2. A method for treating a patient suffering from a taxol-sensitive tumor comprising (i) premedicating said patient with a medicament that reduces or eliminates hypersensitivity reactions; and (ii) parenterally administering to said patient about 135 mg/m.sup.2 taxol over about three hours. 3. A method for treating a patient suffering from a taxol-sensitive ovarian tumor comprising (i) premedicating said patient with a medicament that reduces or eliminates hypersensitivity reactions; and (ii) parenterally administering to said patient about 135-175 mg/m.sup.2 taxol. 4. A method for treating a patient suffering from a taxol-sensitive ovarian tumor comprising (i) premedicating said patient with a medicament that reduces or eliminates hypersensitivity reactions; and (ii) parenterally administering to said patient about 135 mg/m.sup.2 taxol over about three hours. 5. A method for treating a cancer patient to effect regression of a taxol-sensitive tumor, said method being associated with reduced hematologic toxicity, said method comprising: (i) premedicating said patient with a medicament that reduces or eliminates hypersensitivity reactions; and (ii) parenterally administering to said patient about 135-175 mg/m.sup.2 taxol over about 3 hours. 6. The method of claim 5 wherein the step of premedicating said patient comprises the administration of a medicament selected from the group consisting of steroids, antihistamines, H.sub.2 receptor antagonists, and combinations thereof. 7. The method of claim 6 wherein said taxol-sensitive tumor is an ovarian tumor. 8. A method for treating a cancer patient to effect regression of a taxol-sensitive tumor, said method being associated with reduced hematologic toxicity, said method comprising: (i) premedicating said patient with a medicament that reduces or eliminates hypersensitivity reactions; and (ii) parenterally administering to said patient about 135 mg/m.sup.2 taxol over about 3 hours. 9. The method of claim 8 wherein the step of premedicating said patient comprises the administration of a medicament selected from the group consisting of steroids, antihistamines, H.sub.2 receptor antagonists, and combinations thereof. 10. The method of claim 9 wherein said taxol-sensitive tumor is an ovarian tumor.