BMS-247550 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy

June 20, 2013 updated by: Southwest Oncology Group

A Phase II Trial of Epothilone B Analogue BMS-247550 (NSC #710428) (IND 59699) Administered Every 21 Days in Patients With Hormone Refractory Prostate Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating patients who have prostate cancer that has not responded to hormone therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the prostate-specific antigen response to BMS-247550 in patients with hormone-refractory prostate cancer.
  • Determine the overall survival and progression-free survival rate in patients treated with this drug.
  • Determine the objective response rate (confirmed and unconfirmed complete and partial responses) in those patients with measurable disease treated with this drug.
  • Evaluate the qualitative and quantitative toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive BMS-247550 IV over 3 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses beyond CR.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 25-45 patients will be accrued for this study within 5-9 months.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033-0804
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Sacramento, California, United States, 95817
        • University of California Davis Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30342-1701
        • CCOP - Atlanta Regional
    • Illinois
      • Hines, Illinois, United States, 60141
        • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
    • Kansas
      • Kansas City, Kansas, United States, 66160-7390
        • University Of Kansas Medical Center
      • Wichita, Kansas, United States, 67214-3882
        • CCOP - Wichita
      • Wichita, Kansas, United States, 67218
        • Veterans Affairs Medical Center - Wichita
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • MBCCOP - LSU Health Sciences Center
      • Shreveport, Louisiana, United States, 71130-3932
        • Louisiana State University Health Sciences Center - Shreveport
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0330
        • University of Michigan Comprehensive Cancer Center
      • Detroit, Michigan, United States, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
      • Detroit, Michigan, United States, 48201-1932
        • Veterans Affairs Medical Center - Detroit
      • Grand Rapids, Michigan, United States, 49503
        • CCOP - Grand Rapids
    • New York
      • New York, New York, United States, 10032
        • Herbert Irving Comprehensive Cancer Center at Columbia University
      • Rochester, New York, United States, 14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
    • Oregon
      • Portland, Oregon, United States, 97207
        • Veterans Affairs Medical Center - Portland
      • Portland, Oregon, United States, 97201-3098
        • Oregon Cancer Institute
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Hollings Cancer Center at Medical University of South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • CCOP - Upstate Carolina
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Danville Radiation Therapy Center
    • Texas
      • Amarillo, Texas, United States, 79106
        • Harrington Cancer Center
      • Amarillo, Texas, United States, 79106
        • Veterans Affairs Medical Center - Amarillo
      • Fort Sam Houston, Texas, United States, 78234-6200
        • Brooke Army Medical Center
      • San Antonio, Texas, United States, 78229-3900
        • University of Texas Health Science Center at San Antonio
      • San Antonio, Texas, United States, 78229
        • Veterans Affairs Medical Center - San Antonio (Murphy)
      • Temple, Texas, United States, 76508
        • CCOP - Scott and White Hospital
    • Washington
      • Seattle, Washington, United States, 98108
        • Veterans Affairs Medical Center - Seattle
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate

    • Stage D1 or D2 disease (T4, N0, M0; any T, N1-3, M0; or any T, any N, M1)

  • Unresponsive or refractory to prior hormonal therapy by at least 1 of the following:

    • Progression of unidimensionally measurable lesion outside of a prior radiation port
    • Progression of non-measurable disease (e.g., bone scan)
  • Rising prostate-specific antigen (PSA) on at least 2 consecutive measurements taken at least 7 days apart
  • PSA at least 5 ng/mL
  • No brain metastases

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than upper limit of normal (ULN)
  • SGOT or SGPT no greater than 2.5 times ULN

Renal:

  • Creatinine no greater than 2.0 mg/dL OR
  • Creatinine clearance at least 40 mL/min

Other:

  • No other malignancy within the past 5 years except adequately treated squamous cell or basal cell skin cancer, any carcinoma in situ, or stage I or II cancer in complete remission
  • No other concurrent significant active illness that would preclude study participation
  • Recovered from major infections
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 28 days since prior biologic therapy and recovered
  • No more than 1 prior biologic (non-cytotoxic) therapy
  • No concurrent biological response modifiers

Chemotherapy:

  • No prior chemotherapy for this disease
  • No other concurrent chemotherapy

Endocrine therapy:

  • See Disease Characteristics
  • At least 28 days since prior flutamide or ketoconazole
  • At least 42 days since prior bicalutamide or nilutamide
  • No concurrent hormonal therapy, except luteinizing hormone-releasing hormone therapy
  • No concurrent corticosteroids

Radiotherapy:

  • See Disease Characteristics
  • Prior radiotherapy to less than 30% of bone marrow allowed
  • No prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium
  • At least 28 days since prior radiotherapy and recovered
  • No concurrent radiotherapy

Surgery:

  • Recovered from prior surgery
  • Prior orchiectomy allowed

Other:

  • No concurrent unconventional therapy (e.g., St. John's Wort, PC-SPES, or other herbal remedy for prostate cancer)
  • Not planning to begin bisphosphonate therapy (patients already receiving bisphosphonates are eligible provided they have progressive disease)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Maha Hadi A. Hussain, MD, University of Michigan Rogel Cancer Center
  • Primo N. Lara, MD, University of California, Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2001

Study Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

May 6, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

June 24, 2013

Last Update Submitted That Met QC Criteria

June 20, 2013

Last Verified

February 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068629
  • SWOG-S0111

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

Clinical Trials on ixabepilone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe