Neoadjuvant Weekly Ixabepilone for High Risk, Clinically Localized Prostate Cancer

Sponsor
Brown University (Other)
Overall Status
Completed
CT.gov ID
NCT00828308
Collaborator
Rhode Island Hospital (Other), The Miriam Hospital (Other)
16
1
1
94
0.2

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
N/A
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
Actual Study Start Date :
Feb 1, 2009
Actual Primary Completion Date :
Mar 1, 2011
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
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.
Other Names:
  • Ixempra
  • Procedure: Prostatectomy
    Prostatectomy 2-8 weeks after completion ***this was standard of care and not a part of the study**
    Other Names:
  • Prostatectomy 2-8 weeks after completion ***this was standard of care and not a part of the study**
  • Outcome Measures

    Primary Outcome Measures

    1. Prostate-Specific Antigen (PSA) Response [after 12 weeks of ixabepilone]

      Decrease in PSA:number of participants with decreased serum PSA level after 12 weeks of ixabepilone

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Miriam Hospital Providence Rhode Island United States 02906

    Sponsors and Collaborators

    • Brown University
    • Rhode Island Hospital
    • The Miriam Hospital

    Investigators

    • Study Chair: Howard Safran, MD, BrUOG Study Chair

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Brown University
    ClinicalTrials.gov Identifier:
    NCT00828308
    Other Study ID Numbers:
    • BrUOG-Pros-221
    First Posted:
    Jan 23, 2009
    Last Update Posted:
    Mar 8, 2022
    Last Verified:
    Feb 1, 2022
    Keywords provided by Brown University
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details First patient enrolled 2/11/09 and last patient enrolled was 3/30/11
    Pre-assignment Detail
    Arm/Group Title Ixabepilone
    Arm/Group 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.
    Period Title: Overall Study
    STARTED 16
    COMPLETED 16
    NOT COMPLETED 0

    Baseline Characteristics

    Arm/Group Title Ixabepilone
    Arm/Group Description Ixabepilone, 16 mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy 2-8 weeks after completion of chemotherapy (this was standard of care and not a part of the study)
    Overall Participants 16
    Age (Count of Participants)
    <=18 years
    0
    0%
    Between 18 and 65 years
    12
    75%
    >=65 years
    4
    25%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    56.5
    (29)
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    Male
    16
    100%
    Region of Enrollment (participants) [Number]
    United States
    16
    100%

    Outcome Measures

    1. Primary Outcome
    Title Prostate-Specific Antigen (PSA) Response
    Description Decrease in PSA:number of participants with decreased serum PSA level after 12 weeks of ixabepilone
    Time Frame after 12 weeks of ixabepilone

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Ixabepilone
    Arm/Group Description Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy will occur 2-8 weeks after completion of chemotherapy.
    Measure Participants 16
    Number [participants]
    14
    87.5%

    Adverse Events

    Time Frame Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.
    Adverse Event Reporting Description
    Arm/Group Title Ixabepilone
    Arm/Group Description Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy will occur 2-8 weeks after completion of chemotherapy.
    All Cause Mortality
    Ixabepilone
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    Ixabepilone
    Affected / at Risk (%) # Events
    Total 1/16 (6.3%)
    Investigations
    pneumonia (3) with normal ANC, post infuection bronchitis (3), wheezing (3) 1/16 (6.3%) 1
    Other (Not Including Serious) Adverse Events
    Ixabepilone
    Affected / at Risk (%) # Events
    Total 16/16 (100%)
    Investigations
    Constipation 6/16 (37.5%) 6
    nasuea 3/16 (18.8%) 3
    neuorapthy 13/16 (81.3%) 13
    fatigue 11/16 (68.8%) 11
    diarrhea 7/16 (43.8%) 7
    taste alteration 3/16 (18.8%) 3
    heartburn 1/16 (6.3%) 1
    pain 1/16 (6.3%) 1
    dehydration 3/16 (18.8%) 3
    insomnia 4/16 (25%) 4
    wt loss 3/16 (18.8%) 3
    rash/pruritus 2/16 (12.5%) 2
    anorexia 1/16 (6.3%) 1
    hyperpigmentation 1/16 (6.3%) 1
    abdominal cramping/pain 4/16 (25%) 4
    dysphagia 1/16 (6.3%) 1
    urinary frequency 2/16 (12.5%) 2
    allergic reaction/hypersensitivity reaction 3/16 (18.8%) 3
    edema 1/16 (6.3%) 1
    rhinitis 2/16 (12.5%) 2
    depression 1/16 (6.3%) 1
    infection 4/16 (25%) 4
    alopecia 5/16 (31.3%) 5
    HTN 1/16 (6.3%) 1
    shortness of breath 1/16 (6.3%) 1
    headache 1/16 (6.3%) 1
    muscle aches/myalgia 2/16 (12.5%) 2
    wheezing 1/16 (6.3%) 1
    cough 1/16 (6.3%) 1
    WBC 1/16 (6.3%) 1
    ANC 1/16 (6.3%) 1
    HGB 2/16 (12.5%) 2
    pain-joint 1/16 (6.3%) 1
    sore throat 3/16 (18.8%) 3
    flushing 1/16 (6.3%) 1
    flatulence 1/16 (6.3%) 1
    mood 1/16 (6.3%) 1
    pain-mouth 1/16 (6.3%) 1
    pain-muscle 1/16 (6.3%) 1
    hoarseness 1/16 (6.3%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Anthony Mega, MD
    Organization BrUOG
    Phone 4018633000
    Email BrUOG@brown.edu
    Responsible Party:
    Brown University
    ClinicalTrials.gov Identifier:
    NCT00828308
    Other Study ID Numbers:
    • BrUOG-Pros-221
    First Posted:
    Jan 23, 2009
    Last Update Posted:
    Mar 8, 2022
    Last Verified:
    Feb 1, 2022