METHODS FOR TREATMENT OF BLADDER CANCER WITH GEMCITABINE
Drug delivery devices and methods are provided for administering gemcitabine to a patient in need of treatment of bladder cancer by intravesically administering gemcitabine into the bladder of the patient to achieve a sustained concentration of the gemcitabine in urine in the bladder sufficient to produce a therapeutically effective concentration of the gemcitabine in the tissues of the bladder. In embodiments, the local administration into the patient's bladder is at a mean average amount of from 1 mg/day to about 300 mg/day of the gemcitabine (FBE).
1 . A method for treating non-muscle invasive bladder cancer (NMIBC) in a human patient, comprising:
deploying into the patient's bladder an intravesical drug delivery device which comprises gemcitabine; and
releasing the gemcitabine from the intravesical drug delivery device into the patient's bladder to produce a therapeutic concentration of the gemcitabine in bladder tissues effective to treat NMIBC in the patient,
wherein the gemcitabine is released continuously into the patient's bladder, at a mean average amount of from 10 mg/day to 50 mg/day of the gemcitabine free base equivalent (FBE) over a treatment period of from 7 day to 21 days, and
wherein the intravesical device releases the gemcitabine in a manner that produces gemcitabine urine concentrations in the bladder that are well tolerated by the urothelium.
2 . The method of claim 1 , wherein the intravesical drug delivery device comprises a housing which contains and controls release of the gemcitabine.
3 . The method of claim 2 , wherein the housing comprises a release orifice in communication with a drug reservoir in which the gemcitabine is contained along with an osmotic agent.
4 . A method for treating non-muscle invasive bladder cancer (NMIBC) in a human patient, comprising:
deploying into the patient's bladder an intravesical drug delivery device which comprises gemcitabine; and
releasing the gemcitabine from the intravesical drug delivery device into the patient's bladder to produce a therapeutic concentration of the gemcitabine in bladder tissues effective to treat NMIBC in the patient,
wherein the gemcitabine is released continuously into the patient's bladder, at a mean average amount of from 10 mg/day to 50 mg/day of the gemcitabine (FBE) over a treatment period of 14 days to 21 days, and
wherein the intravesical device releases the gemcitabine in a manner that produces gemcitabine urine concentrations in the bladder that are well tolerated by the urothelium.
5 . The method of claim 4 , wherein the intravesical drug delivery device comprises a housing which contains and controls release of the gemcitabine.
6 . The method of claim 5 , wherein the housing comprises a laser-drilled release orifice in communication with a drug reservoir in which the gemcitabine is contained along with an osmotic agent and a viscosity enhancing agent.
7 . A method for treating non-muscle invasive bladder cancer (NMIBC) in a human patient, comprising:
deploying into the patient's bladder an intravesical drug delivery device which comprises gemcitabine; and
releasing the gemcitabine from the intravesical drug delivery device into the patient's bladder to produce a therapeutic concentration of the gemcitabine in bladder tissues effective to treat NMIBC in the patient,
wherein the gemcitabine is released continuously into the patient's bladder, at a mean average amount of about 10 mg/day of the gemcitabine (FBE) over a treatment period of from 7 days to 21 days, and
wherein the intravesical device releases the gemcitabine in a manner that produces gemcitabine urine concentrations in the bladder that are well tolerated by the urothelium.
8 . The method of claim 9 , wherein the intravesical drug delivery device comprises a housing which contains and controls release of the gemcitabine.
9 . The method of claim 8 , wherein the housing comprises a release orifice in communication with a drug reservoir in which the gemcitabine is contained along with an osmotic agent.
10 . The method of claim 8 , wherein the housing comprises a laser-drilled release orifice in communication with a drug reservoir in which the gemcitabine is contained along with an osmotic agent and a viscosity enhancing agent.
11 . A method for treating non-muscle invasive bladder cancer (NMIBC) in a human patient, comprising:
deploying into the patient's bladder an intravesical drug delivery device which comprises gemcitabine HCl; and
releasing the gemcitabine from the intravesical drug delivery device into the patient's bladder to produce a therapeutic concentration of the gemcitabine in bladder tissues effective to treat NMIBC in the patient,
wherein the gemcitabine is released continuously into the patient's bladder, at a mean average amount of from 10 mg/day to 50 mg/day of the gemcitabine (FBE) over a treatment period of 7 days to 21 days, and
wherein the intravesical device releases the gemcitabine by osmotic pressure in a manner that produces gemcitabine urine concentrations in the bladder that are well tolerated by the urothelium.
12 . The method of claim 11 , wherein the intravesical drug delivery device comprises a housing which contains and controls release of the gemcitabine through a laser-drilled release orifice in communication with a drug reservoir in which the gemcitabine is contained.
13 . The method of claim 12 , wherein the drug reservoir further comprises an osmotic agent.
14 . The method of claim 12 , wherein the drug reservoir further comprises an osmotic agent and a viscosity enhancing agent.
15 . The method of claim 12 , wherein the laser-drilled release orifice is a 150-micron orifice.