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

This study has been completed.
Sponsor:
Information provided by:
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00082134
First received: April 29, 2004
Last updated: June 19, 2008
Last verified: October 2006
  Purpose

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 Intervention Phase
Hormone-Refractory Prostate Cancer
Drug: ILX651
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Genzyme, a Sanofi Company:

Estimated Enrollment: 40
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00082134

Locations
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00082134     History of Changes
Other Study ID Numbers: ILX651-241
Study First Received: April 29, 2004
Last Updated: June 19, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Genzyme, a Sanofi Company:
Prostate cancer
Hormone-refractory prostate cancer
HRPC
Prostate
Docetaxel
PSA progression
PSA progressed

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Hormones
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014