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Study of ILX651 in Patients With Hormone-Refractory Prostate Cancer Previously Treated With Docetaxel

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00082134
Recruitment Status : Completed
First Posted : May 4, 2004
Last Update Posted : March 5, 2015
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Hormone-refractory Prostate Cancer Drug: ILX651 Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00082134

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United States, Arizona
Arizona Clinical Research Center
Tucson, Arizona, United States
United States, Kansas
Kansas City Cancer Centers
Lenexa, Kansas, United States
Kansas City Cancer Centers
Overland Park, Kansas, United States
United States, Missouri
Kansas City Cancer Centers- Central
Kansas City, Missouri, United States
United States, North Carolina
Cancer Center of North Carolina- Cary
Cary, North Carolina, United States
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States
United States, Texas
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
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States
Cancer Care Northwest
Spokane, Washington, United States, 99218
Sponsors and Collaborators
Genzyme, a Sanofi Company
Layout table for additonal information Identifier: NCT00082134    
Other Study ID Numbers: ILX651-241
First Posted: May 4, 2004    Key Record Dates
Last Update Posted: March 5, 2015
Last Verified: March 2015
Keywords provided by Sanofi:
Prostate cancer
Hormone-refractory prostate cancer
PSA progression
PSA progressed
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases