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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
Not Enrolling
Hormone-Refractory Prostate Cancer

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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

- 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

- 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

Type of Study:


Study Design:

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


United States: Food and Drug Administration

Study ID:




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



Swedish Cancer Institute Seattle, Washington  98104
Arizona Clinical Research Center Tucson, Arizona  85712
Joe Arrington Cancer Center Lubbock, Texas  79410
Cancer Care Northwest Spokane, Washington  99202
North Texas Regional Cancer Center Plano, Texas  75075
Oregon Health and Science University Portland, Oregon  97201
Texas Cancer Center at Medical City Dallas, Texas  75230
Kansas City Cancer Centers Lenexa, Kansas  
Kansas City Cancer Centers- Central Kansas City, Missouri  
Cancer Center of North Carolina- Cary Cary, North Carolina  
Sammons Cancer Center Dallas, Texas