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Ixabepilone in Treating Patients With Metastatic Prostate Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), January 2009
Sponsors and Collaborators: Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00087139
  Purpose

RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well ixabepilone works in treating patients with metastatic prostate cancer that has not responded to previous hormone therapy.


Condition Intervention Phase
Prostate Cancer
Drug: ixabepilone
Phase II

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Ixabepilone
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Study of a Weekly Schedule of BMS-247550 for Patients With Hormone Refractory Prostate Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Prostate-specific antigen (PSA) response defined as a 50% decline in PSA [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measurable disease response as defined by RECIST criteria [ Designated as safety issue: No ]
  • Overall response [ Designated as safety issue: No ]

Estimated Enrollment: 83
Study Start Date: September 2004
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To determine the effect on percent with a 50% decrease in 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)

Secondary

  • 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 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.

PROJECTED ACCRUAL: A total of 83 patients (27 for the no prior chemotherapy stratum; 27 each for the 2 prior cytotoxic chemotherapy regimens and prior docetaxel strata) will be accrued for this study within 8-22 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate

    • Metastatic disease
  • Evidence of disease progression (e.g., new lesions on bone scan or new/enlarging lesions on CT scan) OR rising prostate-specific antigen (PSA) within the past 4 weeks

    • Radiologic evidence of hydronephrosis alone is not considered evidence of metastatic disease (e.g., increasing PSA)
    • Patients with bone metastases only (i.e., lacking soft tissue disease) must have a PSA level ≥ 10 ng/mL within the past week
    • Patients with soft tissue metastasis and/or visceral disease must have measurable disease OR a PSA level ≥ 10 ng/mL within the past week
    • Patients with stable 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 the past 4 weeks
    • Disease progression after prior anti-androgen withdrawal must be confirmed by a rising PSA after the 4-6 week washout period (e.g., PSA level higher than the last PSA obtained while on anti-androgen therapy)
  • 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 AND must have a serum testosterone level ≤ 50 ng/dL within the past 4 weeks to confirm androgen suppression
  • No carcinomatous meningitis or brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • WBC ≥ 4,000/mm^3

Hepatic

  • SGPT ≤ 2 times upper limit of normal
  • Bilirubin ≤ 1.5 mg/dL
  • INR normal

Renal

  • Creatinine ≤ 1.5 mg/dL OR
  • Creatinine clearance ≥ 50 mL/min

Cardiovascular

  • No active angina pectoris
  • No New York Heart Association class III-IV heart disease
  • No myocardial infarction within the past 6 months
  • No evidence of ventricular dysrhythmias or other unstable arrhythmia

    • Rate-controlled atrial fibrillation allowed provided the patient is asymptomatic

Other

  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer
  • No peripheral neuropathy > grade 1
  • No serious medical illness or active infection that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent prophylactic filgrastim (G-CSF)

Chemotherapy

  • No more than 2 prior cytotoxic chemotherapy regimens for hormone-refractory disease
  • At least 4 weeks since prior chemotherapy with a taxane-based regimen, mixantrone, or another cytotoxic chemotherapy regimen provided there is evidence of progressive disease

Endocrine therapy

  • See Disease Characteristics
  • 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
  • At least 4 weeks since prior estrogen or estrogen-like agents (e.g., PC-SPES, saw palmetto, or other herbal products which may contain phytoestrogens)
  • At least 4 weeks since prior hormonal therapy, including megestrol, finasteride, ketoconazole, or systemic corticosteroids
  • No concurrent estrogen or estrogen-like agents (e.g., PC-SPES, saw palmetto, or other herbal products which may contain phytoestrogens)
  • No concurrent hormonal therapy, including megestrol, finasteride, ketoconazole, or systemic corticosteroids

Radiotherapy

  • More than 4 weeks since prior radiotherapy
  • No prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium
  • No other prior radioisotope
  • No concurrent radiotherapy for pain control

Surgery

  • See Disease Characteristics

Other

  • No more than 1 prior experimental (non-cytotoxic) therapy AND evidence of progressive disease
  • At least 4 weeks since prior experimental therapy
  • Concurrent bisphosphonates (e.g., pamidronate or zoledronate) allowed provided treatment was initiated at least 4 weeks ago and there is evidence of progressive disease
  • No concurrent therapeutic warfarin

    • Concurrent prophylactic or therapeutic doses of low molecular weight heparin allowed provided criterion for INR is met
  • No other concurrent investigational agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00087139

  Show 174 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Glenn Liu, MD University of Wisconsin, Madison
Investigator: Robert S. DiPaola, MD Cancer Institute of New Jersey
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Wilding G, Chen Y, DiPaola RP, et al.: E3803: Updated results on phase II study of a weekly schedule of BMS-247550 for patients with castrate refractory prostate cancer (CRPC). [Abstract] J Clin Oncol 26 (Suppl 15): A-5070, 2008.
Liu G, Wang W, DiPaola R, et al.: A phase II study of a weekly schedule of BMS-247550 for patients with hormone-refractory prostate cancer: a trial of the Eastern Cooperative Oncology Group (E3803). [Abstract] J Clin Oncol 24 (Suppl 18): A-4618, 2006.

Study ID Numbers: CDR0000372946, ECOG-E3803
Study First Received: July 8, 2004
Last Updated: January 6, 2009
ClinicalTrials.gov Identifier: NCT00087139  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
recurrent prostate cancer
stage IV prostate cancer

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Epothilones
Urogenital Neoplasms
Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009