Study of ILX651 in Patients With Hormone-Refractory Prostate Cancer Previously Treated With Docetaxel
A Phase II Study of ILX651 Administered Intravenously Daily for Five Consecutive Days Every 21 Days in Patients With Hormone-Refractory Prostate Cancer Previously Treated With Docetaxel
1 other identifier
interventional
40
1 country
12
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 study that is expected to last 24 months. All patients will be treated with ILX651 administered IV daily for 5 consecutive days every 21 days. The primary objective of this study is to determine the PSA response rate. The secondary objectives are to determine response of measurable disease, duration of response, time to PSA progression, time to treatment failure, survival, safety and tolerability, and pharmacokinetic profile of ILX651.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2004
CompletedFirst Posted
Study publicly available on registry
May 4, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedMarch 5, 2015
March 1, 2015
April 29, 2004
March 4, 2015
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Arizona Clinical Research Center
Tucson, Arizona, United States
Kansas City Cancer Centers
Lenexa, Kansas, United States
Kansas City Cancer Centers
Overland Park, Kansas, United States
Kansas City Cancer Centers- Central
Kansas City, Missouri, United States
Cancer Center of North Carolina- Cary
Cary, North Carolina, United States
Oregon Health and Science University
Portland, Oregon, United States
Sammons Cancer Center
Dallas, Texas, United States
Texas Cancer Center at Medical City
Dallas, Texas, United States
Joe Arrington Cancer Center
Lubbock, Texas, United States
North Texas Regional Cancer Center
Plano, Texas, United States
Swedish Cancer Institute
Seattle, Washington, United States
Cancer Care Northwest
Spokane, Washington, 99218, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 29, 2004
First Posted
May 4, 2004
Study Completion
December 1, 2005
Last Updated
March 5, 2015
Record last verified: 2015-03