Methods and compositions useful for administration of chemotherapeutic agents

A method for the administration of a taxane to a subject in need thereof, said method comprising systemically administering a dose in the range of about 30 mg/m.sup.2 to about 1000 mg/m.sup.2 of said taxane to said subject in a pharmaceutically acceptable formulation substantially free of cremophor without the use of premedication, with a treatment cycle of no greater than 2 weeks.

A method for reducing the hematologic toxicity of a taxane in a subject undergoing treatment with taxane, said method comprising systemically administering a dose in the range of about 30 mg/m.sup.2 to about 1000 mg/m.sup.2 of said taxane to said subject in a pharmaceutically acceptable formulation, wherein said pharmaceutically acceptable formulation is substantially free of cremophor.

A method for reducing the cerebral or neurologic toxicity of taxane in a subject undergoing treatment with taxane, said method comprising systemically administering a dose in the range of about 30 mg/m.sup.2 to about 1000 mg/m.sup.2 of said taxane to said subject in a pharmaceutically acceptable formulation, wherein said pharmaceutically acceptable formulation is substantially free of cremophor.

A method for treatment of primary tumors in a subject by achieving high local concentration of taxane at the tumor site, said method comprising systemically administering a dose in the range of about 30 mg/m.sup.2 to about 1000 mg/m.sup.2 of said taxane to said subject in a pharmaceutically acceptable formulation substantially free of cremophor.

A pharmaceutically acceptable formulation of taxane for treatment of primary tumors in a subject which achieves high local concentration of said taxane at the tumor site, said formulation being substantially free of cremophor and comprising taxane in a dose in the range of about 30 mg/m.sup.2 to about 1000 mg/m.sup.2.

A method for treatment of metastatic tumors in a subject by achieving high local concentration of taxane at the site of metastases, said method comprising systemically administering a dose in the range of about 30 mg/m.sup.2 to about 1000 mg/m.sup.2 of said taxane to said subject in a pharmaceutically acceptable formulation substantially free of cremophor.

A method for treatment of prostatic cancer in a subject by inducing a medical orchiectomy by administering a dose of taxane in the range of about 30 mg/m.sup.2 to about 1000 mg/m.sup.2 to said subject in a pharmaceutically acceptable formulation substantially free of cremophor.

A unit dosage form comprising a vessel containing a sufficient quantity of taxane to allow systemic administration at a dose in the range of about 30 mg/m.sup.2 to about 1000 mg/m.sup.2 over an administration period of less than 3 hours.

A lyophilized taxane-containing formulation characterized by the ability to be reconstituted at concentrations greater than 1.3 mg/ml, and remaining stable for at least 3 days.

A taxane-containing formulation suitable for administration using standard intravenous infusion tubing, wherein said taxane-containing formulation has a concentration of greater than 1.3 mg/ml.

A taxane-containing formulation suitable for delivery of a dose in the range of about 30 mg/m.sup.2 to about 1000 mg/m.sup.2 with an administration period of less than 3 hrs.

A pharmaceutically acceptable formulation of taxane comprising in the range of about 30 mg/m.sup.2 to about 1000 mg/m.sup.2 of taxane, wherein said formulation is useful for the reduction of serum testosterone levels in a subject.