Status:
COMPLETED
Study of ILX651 in Patients With Hormone-Refractory Prostate Cancer Previously Treated With Docetaxel
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Hormone-refractory Prostate Cancer
Eligibility:
MALE
19+ years
Phase:
PHASE2
Brief Summary
This is a Phase II, non-randomized, open label study of ILX651 in patients with hormone-refractory prostate cancer previously treated with docetaxel. Approximately 40 patients will be enrolled in this...
Eligibility Criteria
Inclusion
- Patient has hormone-refractory prostate cancer (HRPC) as evidenced by PSA progression or progression of measurable disease.
- Patient has greater than 25% increase in 2 consecutive tests in which the first increase in PSA should occur a minimum of 1 week apart.
- Patients on androgen deprivation treatment and will continue on androgen deprivation treatment during study participation except for patients who are post orchiectomy.
- Patient has evidence of metastatic disease by positive bone scan or evidence of progressive metastatic disease by CT scan.
- Patient has been treated with at least 1 prior hormone therapy or is post orchiectomy.
- Patient has been previously treated at a minimum for an 8-week treatment period on a docetaxel-based regimen for metastatic HRPC.
- Patient has PSA at least 5 ng/mL or greater.
- Patient has testosterone less than 50 ng/dL.
- Patient ECOG performance status of 0 or 1.
- Patient has life expectancy of greater than 8 weeks.
- Patient meets lab values: A. Absolute neutrophil count at least 1,500/mm\^3 or greater; B.Platelet count at least 100,000/mm\^3 or greater; C. Serum creatinine at least 1.5 mg/dL or less or creatinine clearance at least 60 mL/min or greater; D. Bilirubin less than 2.0 mg/dL. E. AST and ALT less or equal to 2.5 times upper limit of normal
- Any chemotherapy, major surgery, or irradiation must be completed at least 4 weeks prior to study drug.
- Patient recovered from clinically significant toxicities from prior treatment.
Exclusion
- Prior treatment with 2 or more prior chemotherapy regimens.
- Concurrent treatment with an estrogen-containing agent including diethylstilbestrol (DES).
- Prior flutamide (Eulexin) within past 4 weeks, prior bicalutamide (Casodex) within past 6 weeks, or prior nilutamide (Nilandron) within past 6 weeks.
- Prior strontium or samarium or other radioisotope therapy.
- Prior radiation therapy to greater than 25% of the bone marrow (e.g., no whole pelvic irradiation is allowed).
- Uncontrolled congestive heart failure or angina, patients with a history of myocardial infarction within 2 months of enrollment.
- Patients with uncontrolled hypertension.
- Pre-existing cardiac, pulmonary, neurologic or other disease that would preclude study participation.
- Documented untreated central nervous system (CNS) metastases. However, patients with treated CNS metastases that have been stable are eligible.
- Any significant concurrent disease or illness, or psychiatric disorders or alcohol or chemical abuse that would preclude study participation.
- Active secondary malignancy except non-melanoma skin cancers.
- Known, active infection, or known HIV positive or presence of an AIDS related illness.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00082134
End Date
December 1 2005
Last Update
March 5 2015
Active Locations (12)
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1
Arizona Clinical Research Center
Tucson, Arizona, United States
2
Kansas City Cancer Centers
Lenexa, Kansas, United States
3
Kansas City Cancer Centers
Overland Park, Kansas, United States
4
Kansas City Cancer Centers- Central
Kansas City, Missouri, United States