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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


Phase 2
19 Years
N/A
Not Enrolling
Male
Hormone-Refractory Prostate Cancer

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

ILX651-241

NCT ID:

NCT00082134

Start Date:

Completion Date:

Related Keywords:

  • Hormone-Refractory Prostate Cancer
  • Prostate cancer
  • Hormone-refractory prostate cancer
  • HRPC
  • Prostate
  • Docetaxel
  • PSA progression
  • PSA progressed
  • Prostatic Neoplasms

Name

Location

Swedish Cancer InstituteSeattle, Washington  98104
Arizona Clinical Research CenterTucson, Arizona  85712
Joe Arrington Cancer CenterLubbock, Texas  79410
Cancer Care NorthwestSpokane, Washington  99202
North Texas Regional Cancer CenterPlano, Texas  75075
Oregon Health and Science UniversityPortland, Oregon  97201
Texas Cancer Center at Medical CityDallas, Texas  75230
Kansas City Cancer CentersLenexa, Kansas  
Kansas City Cancer Centers- CentralKansas City, Missouri  
Cancer Center of North Carolina- CaryCary, North Carolina  
Sammons Cancer CenterDallas, Texas