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

March 4, 2015 updated by: Genzyme, a Sanofi Company

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States
        • Arizona Clinical Research Center
    • Kansas
      • Lenexa, Kansas, United States
        • Kansas City Cancer Centers
      • Overland Park, Kansas, United States
        • Kansas City Cancer Centers
    • Missouri
      • Kansas City, Missouri, United States
        • Kansas City Cancer Centers- Central
    • North Carolina
      • Cary, North Carolina, United States
        • Cancer Center of North Carolina- Cary
    • Oregon
      • Portland, Oregon, United States
        • Oregon Health and Science University
    • Texas
      • Dallas, Texas, United States
        • Texas Cancer Center at Medical City
      • Dallas, Texas, United States
        • Sammons Cancer Center
      • Lubbock, Texas, United States
        • Joe Arrington Cancer Center
      • Plano, Texas, United States
        • North Texas Regional Cancer Center
    • Washington
      • Seattle, Washington, United States
        • Swedish Cancer Institute
      • Spokane, Washington, United States, 99218
        • Cancer Care Northwest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genzyme, a Sanofi Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

April 29, 2004

First Submitted That Met QC Criteria

May 3, 2004

First Posted (Estimate)

May 4, 2004

Study Record Updates

Last Update Posted (Estimate)

March 5, 2015

Last Update Submitted That Met QC Criteria

March 4, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILX651-241

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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