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Neoadjuvant Weekly Ixabepilone for High Risk, Clinically Localized Prostate Cancer (BrUOG-Pros-221)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00828308
First Posted: January 23, 2009
Last Update Posted: March 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Rhode Island Hospital
The Miriam Hospital
Information provided by (Responsible Party):
Dr Anthony Mega, Brown University
  Purpose

Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles.

Prostatectomy 2-8 weeks after completion(standard of care and not a part of study)


Condition Intervention Phase
Prostate Cancer Drug: Ixabepilone Procedure: Prostatectomy Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: BrUOG-PROS-221 Neoadjuvant Weekly Ixabepilone for High Risk, Clinically Localized Prostate Cancer: A Phase II Study

Resource links provided by NLM:


Further study details as provided by Dr Anthony Mega, Brown University:

Primary Outcome Measures:
  • Prostate-Specific Antigen (PSA) Response [ Time Frame: after 12 weeks of ixabepilone ]
    Decrease in PSA:number of participants with decreased serum PSA level after 12 weeks of ixabepilone


Enrollment: 16
Actual Study Start Date: February 2009
Study Completion Date: December 2016
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ixabepilone

Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles.

Prostatectomy 2-8 weeks after completion ***this was standard of care and not a part of the study***

Drug: Ixabepilone
Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles.
Procedure: Prostatectomy
Other Name: Prostatectomy 2-8 weeks after completion ***this was standard of care and not a part of the study**

Detailed Description:

Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy 2-8 weeks after completion of chemotherapy (this was standard of care).

This protocol evaluated weekly ixabepilone prior to robotic prostatectomy for patients with high risk localized prostate cancer. PSA response rate, tumor margin status and pathologic responses were assessed.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologic documentation of prostatic adenocarcinoma. Patients with small cell, neuroendocrine or transitional cell carcinomas are not eligible.
  • All eligible patients must have a known Gleason sum based on biopsy or TURP at the time of registration.
  • Clinically Localized Disease: Patients must have clinical stage T1-T3a and no radiographic evidence of metastatic disease as demonstrated by:
  • Either CT or MRI of the abdomen and pelvis, that demonstrate no nodes > 1 cm: or endorectal MRI(If one or more lymph nodes(s) measures > 1 cm, a negative biopsy is required.)
  • Negative bone scan (with plain films and /or MRI and/or CT scan confirmation, if necessary).(Positive PET and Prostascint scans are not considered proof of metastatic disease.)
  • Patients must have high risk disease defined as either:

    • Gleason Score 8-10
    • PSA > 15 ng/ml
    • Stage T3a
    • Stage T2c and Gleason score of 7
    • Stage T2b, Gleason score of 7, greater than 50% of the cores positive from a single lobe.
  • No prior treatment for prostate cancer including prior surgery (excluding TURP), pelvic lymph node dissection, radiation therapy, chemotherapy or hormone therapy.
  • Patient must be appropriate candidates for radical prostatectomy with an estimated life expectancy > 10 years as determined by an urologist.
  • ECOG PS 0-1
  • Age > 18 years of age.
  • Required initial laboratory values:

    • ANC > 1500/ul
    • Platelet count > 100,000/mm3
    • Creatinine < 2.0 mg/dl
    • Serum PSA < 100 ng/ml
    • Bilirubin < upper institutional limit of normal (ULN)
    • AST/ALT < 2.5 X ULN

Exclusion Criteria:

  • Active or uncontrolled infection.
  • Patients must not have other coexistent medical condition that would preclude protocol therapy.
  • Previous severe hypersensitivity reaction to a drug formulated in CremophoreL (polyoxyethylated castor oil).
  • Grade 1 or greater neuropathy (motor or sensory) at study entry
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00828308


Locations
United States, Rhode Island
Miriam Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Brown University
Rhode Island Hospital
The Miriam Hospital
  More Information

Additional Information:
Responsible Party: Dr Anthony Mega, Principle Investigator, Brown University
ClinicalTrials.gov Identifier: NCT00828308     History of Changes
Other Study ID Numbers: BrUOG-Pros-221
BMS-CA163-164
First Submitted: January 22, 2009
First Posted: January 23, 2009
Results First Submitted: August 20, 2013
Results First Posted: November 1, 2013
Last Update Posted: March 20, 2017
Last Verified: February 2017

Keywords provided by Dr Anthony Mega, Brown University:
localized
high risk
prostate cancer
neoadjuvant treatment

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Epothilones
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents