NCT00058084

Brief Summary

This randomized phase II trial is studying ixabepilone to see how well it works compared to mitoxantrone and prednisone in treating patients with metastatic prostate cancer that has not responded to paclitaxel, docetaxel, or hormone therapy. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Some tumors become resistant to chemotherapy drugs. Ixabepilone may reduce resistance to the drugs and allow the tumor cells to be killed. It is not yet known which chemotherapy regimen is more effective in treating metastatic prostate cancer

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 7, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2003

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

4.6 years

First QC Date

April 7, 2003

Last Update Submit

February 21, 2017

Conditions

Adenocarcinoma of the ProstateRecurrent Prostate CancerStage IV Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Response to the randomized treatment as determined by > 50% PSA response as measured by RECIST criteria

    The frequency of response with 95% confidence limits for a binomial outcome will be calculated.

    Up to 3 months

Secondary Outcomes (4)

  • Frequency of any toxicity by grade

    Up to 3 months

  • Response duration

    From the date PR or CR is first determined until the first evidence of progressive disease, assessed up to 3 months

  • Time to progressive disease

    From the date protocol therapy is started until the first evidence of progressive disease, assessed up to 3 months

  • Frequency of response to third-line (crossover) therapy

    Up to 3 months

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive ixabepilone (BMS-247550) IV over 3 hours on day 1.

Drug: ixabepilone

Arm II

EXPERIMENTAL

Patients receive mitoxantrone IV over 30 minutes on day 1 and oral prednisone twice daily on days 1-21. In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: mitoxantrone hydrochlorideDrug: prednisone

Interventions

ixabepiloneDRUG

Given IV

Also known as: BMS-247550, epothilone B lactam, Ixempra
Arm I
mitoxantrone hydrochlorideDRUG

Given IV

Also known as: CL 232315, DHAD, DHAQ, Novantrone
Arm II
prednisoneDRUG

Given orally

Also known as: DeCortin, Deltra
Arm II

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed adenocarcinoma of the prostate
  • Metastatic disease (positive bone scan or measurable disease)
  • Progressive hormone-refractory disease
  • Based on 1 of the following:
  • Transaxial imaging
  • Rise in prostate-specific antigen (PSA)
  • Radionuclide bone scan
  • Must have undergone primary hormonal treatment (e.g., orchiectomy or gonadotropin-releasing hormone analog with or without an antiandrogen) and demonstrated disease progression after antiandrogen discontinuation as defined below:
  • Two consecutive rising PSA values, obtained at least 2 weeks apart, or documented osseous or soft tissue progression
  • For patients receiving flutamide, at least 1 PSA value must be obtained at least 4 weeks after flutamide discontinuation
  • For patients receiving bicalutamide or nilutamide, at least 1 PSA value must be obtained at least 6 weeks after antiandrogen discontinuation
  • Ineligible if sole manifestation of progression is an increase in disease-related symptoms
  • Meets 1 of the following criteria:
  • Measurable disease and an elevated PSA
  • Nonmeasurable disease and an elevated PSA, as follows:
  • +46 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94143-0875, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

ixabepiloneMitoxantronePrednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

AnthraquinonesAnthronesAnthracenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsQuinonesPolycyclic CompoundsPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring Compounds

Study Officials

  • Jonathan Rosenberg

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2003

First Posted

April 9, 2003

Study Start

March 1, 2003

Primary Completion

October 1, 2007

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

US(1)