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Study of ILX651 in Patients With Hormone-Refractory Prostate Cancer Previously Treated With Docetaxel | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT00082134•Genzyme, a Sanofi Company

View on ClinicalTrials.gov

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.

Eligibility

Age

19 - No limit years

Sex

MALE

Healthy Volunteers

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.
+3 more criteria

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.
+2 more criteria

Locations (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

Key Dates

Completion Date

December 1, 2005

Last Updated

March 5, 2015

Enrollment

Estimated participants

Conditions

Hormone-refractory Prostate Cancer

Interventions

ILX651

DRUG

Temsirolimus to Reverse Androgen Insensitivity for Castration-resistant Prostate Cancer

NCT01020305

Prostate CancerProstatic Neoplasms+4 more

View study

TERMINATEDPHASE2

YM598 Added to Mitoxantrone/Prednisone to Control Pain in Metastatic Prostate Cancer Patients No Longer Responding to Hormone Therapy

NCT00048659

Hormone-Refractory Prostate CancerProstatic Neoplasms

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Temsirolimus to Reverse Androgen Insensitivity for Castration-resistant Prostate Cancer

YM598 Added to Mitoxantrone/Prednisone to Control Pain in Metastatic Prostate Cancer Patients No Longer Responding to Hormone Therapy

Immunotherapy With APC8015 (Sipuleucel-T, Provenge) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer