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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Rhode Island Hospital
The Miriam Hospital
Information provided by (Responsible Party):
Dr Anthony Mega, Brown University
ClinicalTrials.gov Identifier:
NCT00828308
First received: January 22, 2009
Last updated: April 4, 2013
Last verified: October 2011
History of Changes
  Purpose

Ixabepilone will be given IV weekly for 12 weeks prior to prostatectomy for patients with localized, high risk prostate cancer. The objective of this study is to determine if ixabepilone can shrink prostate cancer prior to prostatectomy.


Condition Intervention Phase
Prostate Cancer
 Drug: ixabepilone
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

Drug Information available for: Ixabepilone
U.S. FDA Resources

Further study details as provided by Brown University:

Primary Outcome Measures:
  • Prostate-Specific Antigen (PSA) response [ Time Frame: after 12 weeks of ixabepilone ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2009
Estimated Study Completion Date: July 2013
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: phase 2 study
weekly ixabepilone for 12 weeks prior to prostatectomy
 Drug: ixabepilone
ixabepilone, 20 mg/m2/week
Other Name: ixabepilone

Detailed Description:

Ixabepilone will be given IV weekly for 12 weeks, in an intensive 20 mg/m2/week schedule, prior to prostatectomy for patients with localized, high risk prostate cancer. The objective of this study is to determine the PSA response and pathologic complete response of weekly ixabepilone.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 22, 2009
Last Updated: April 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013