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Phase II Study of a Weekly Schedule of BMS-247550 for Patients With Hormone Refractory Prostate Cancer

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

Phase II Study of a Weekly Schedule of BMS-247550 for Patients With Hormone Refractory Prostate Cancer



- To determine the effect on percent with a 50% decrease in prostate specific antigen
(PSA) response in patients with metastatic prostate cancer who have progressed on
androgen ablation therapy and are classified into 1 of 3 separate categories:

- Never received prior chemotherapy/cytotoxic therapy

- Received prior taxane-based regimen

- Received 2 prior cytotoxic chemotherapy regimens (including, but not limited to,
prior taxane and anthracyclines)


- Determine measurable disease response in patients with measurable disease treated with
this drug and overall response rate.

- Determine the toxic effects of this drug in these patients.

- Determine the duration of PSA and measurable disease response in patients treated with
this drug.

- Determine the expression of p53, multidrug resistance protein, and Bcl-2 by
immunohistochemistry in the primary tumors of patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to prior
chemotherapy (none vs 1 prior taxane-containing regimen vs 2 prior cytotoxic regimens).

Patients receive ixabepilone intravenously (IV) over 1 hour on days 1, 8, and 15. Courses
repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

ACTUAL ACCRUAL: A total of 124 patients (39 for the no prior chemotherapy stratum; 49 for
the prior taxane stratum; 36 for the 2 prior cytotoxic chemotherapy regimens) were accrued
for this study.

Inclusion Criteria:

- Histologically confirmed adenocarcinoma of the prostate

- Evidence of progressive metastatic disease OR metastatic disease and rising PSA
within 4 weeks prior to registration

- Patients with bone metastases only (i.e., lacking soft tissue disease) must have
a PSA level > 10 ng/mL within a week of registration

- Patients with soft tissue metastasis and/or visceral disease must have
measurable disease OR a PSA level > 10 ng/mL within a week prior to registration

- Patients with stable metastatic disease and rising PSA must show 2 consecutive
rises in PSA measurements taken at least 2 weeks apart; most recent PSA level
must be obtained within 4 weeks of registration

- Failed prior bilateral orchiectomy or other primary hormonal therapy

- Patients who have not undergone bilateral orchiectomy must continue on
luteinizing hormone-releasing hormone (LHRH) agonist therapy (e.g., leuprolide
or goserelin) or LHRH antagonist (e.g., abarelix) during study treatment

- Patients without an orchiectomy must have a serum testosterone level < 50 ng/dL
within 4 weeks of registration to confirm androgen suppression

- No carcinomatous meningitis or brain metastases

- At least 4 weeks since prior flutamide AND continued evidence of progressive disease

- At least 6 weeks since prior bicalutamide or nilutamide AND continued evidence of
progressive disease

- Depending on the strata, no more than 2 prior cytotoxic chemotherapy regimens for
hormone-refractory disease with a taxane-based regimen, mitoxantrone, or another
cytotoxic chemotherapy regimen provided there is evidence of progressive disease

- Up to 1 prior experimental (non-cytotoxic) therapy AND evidence of progressive

- Concurrent bisphosphonates (e.g., pamidronate or zoledronate) allowed provided
treatment was initiated at least 4 weeks ago and there is evidence of progressive

- At least 4 weeks since prior estrogen or estrogen-like agents, or other hormonal
therapy AND disease progression needs to be confirmed by a rising PSA after the
required 4-week washout period

- Adequate bone marrow function

- Serum glutamic-pyruvic transaminase (SGPT) < 2 times the institutional upper limit of

- Bilirubin < 1.5 mg/dL

- Creatinine < 1.5 mg/dL OR a calculated creatinine clearance ≥ 50 mL/min

- Normal international normalized ratio (INR)

- Patients must have electrocardiography (ECG) within 4 weeks of registration

- Patients with a history of prior malignancy are eligible provided they have been
treated with curative intent and free of disease for > 5 years (excluding
non-melanomatous skin cancers treated with curative intent)

- Fertile patients must use effective contraception

- All sites of disease must have been evaluated within 4 weeks of registration

- Age 18 or older

- ECOG performance status (PS) of 0-2

Exclusion Criteria:

- Prior radiotherapy < 4 weeks prior to registration

- Prior Strontium 89, Samarium 153, or other radioisotope

- Concurrent estrogen or estrogen-like agents or any other hormonal therapy

- Active angina pectoris

- New York Heart Association class III-IV heart disease

- Myocardial infarction within 6 months prior to registration

- Evidence of ventricular dysrhythmias or unstable arrhythmia

- Carcinomatous meningitis or brain metastases.

- Peripheral neuropathy > grade 1

- Serious medical illness or active infection that would preclude study participation

- Concurrent investigational agents

Type of Study:


Study Design:

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

Outcome Measure:

Proportion of Patients With PSA Response

Outcome Description:

PSA response is defined as a decline from baseline value by >=50%, or normalization of PSA (PSA < 0.2 ng/lm), confirmed by a second measurement >= 4 weeks later. The proportion of patients with PSA response was reported separately for 3 strata. Additional patients accrued to this study were not included in this analysis.

Outcome Time Frame:

Every 4 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-5 years from study entry

Safety Issue:


Principal Investigator

Glenn Liu, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Wisconsin, Madison


United States: Food and Drug Administration

Study ID:




Start Date:

September 2004

Completion Date:

January 2014

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • recurrent prostate cancer
  • metastatic prostate cancer
  • Prostatic Neoplasms



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