Vinflunine in Hormone Refractory Prostate Cancer (HRPC)

Inclusion Criteria

• •1. Histologically confirmed adenocarcinoma of the prostate.
• •2. Progressive hormone refractory locally advanced or metastatic disease.
• •* (Definition of HRPC): Clinical or serological evidence of disease progression despite adequate anti-androgen therapy, documented by castrate levels of serum testosterone (\<50 ng/mL).
• •* Patients on medical castration therapy should continue on treatment to maintain castrate levels of serum testosterone. Patients receiving anti-androgen or estrogen therapy should either be maintained on it, or have documented progression 4 weeks after withdrawal of all agents (except nilutamide and bicalutamide), which requires 6 weeks.
• •3. Disease Progression, documented by any of the following:
• •* PSA Progression, documented by an elevated PSA level (\>5 ng/mL), which has risen serially from the baseline PSA value (PSA value #1) on two occasions, each at least 1 week apart (these will be considered PSA values #2 and #3). (Note: if the level of PSA value #3 is less than the level of PSA value #2, a subsequent PSA value must be obtained (PSA value #4) at least 1 week after PSA value #3 was measured. In order for this event to be considered a PSA progression, the level of this final PSA value (PSA value #4) must be greater than the PSA level that was observed for PSA value #2.
• •* Progressive metastatic prostate carcinoma, documented by computed tomography (CT), magnetic resonance imaging (MRI), or radiograph of non osseous lesions (see Section 7.2).
• •* Bone Scan Progression, documented by the appearance of at least one or more new lesions that are not believed to be secondary to tumor flare phenomenon.
• •4. Patients with bone only disease must have a PSA level \>=5 ng/mL; patients with stable lesions must have evidence of PSA progression. Patients must have radiographically or clinically demonstrable metastatic disease.
• •5. Receipt of either 1 or 2 previous chemotherapy regimens; one of these regimens must have included docetaxel.
• •6. ECOG performance status of 0-2.
• •7. Adequate bone marrow function, defined by: white blood cells \>=3,500/uL, hemoglobin \>=8 g/dL, platelet count \>=100,000/uL.
• •8. Adequate renal function, defined by: serum creatinine \<1.8 mg/dL, or calculated or measured creatinine clearance (GFR) of \>=60 cc/min. Patients with a creatinine clearance of \>30 mL/min but \<60 mL/min may also be enrolled, but will require an initial adjusted dose (see Section 5.1)
• •9. Adequate hepatic function, defined by: total bilirubin \<1.5 x the upper limit of normal, AST \<2 x the upper limit of normal.
• •10. Patients must be able to comprehend the nature of the study and provide written informed consent.
• •11. Partners of women of childbearing potential must use effective contraception while on treatment and for at least 3 months thereafter. Women of childbearing potential include females who have experienced menarche and have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are not post-menopausal (i.e., amenorrhea \>12 months).
• •12. Patients on bisphosphonate therapy (at the discretion of the investigator).