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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ixabepilone
Sponsored by
SWOG Cancer Research Network
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • USC/Norris Comprehensive Cancer Center and Hospital
  • University of California Davis Cancer Center
  • CCOP - Atlanta Regional
  • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
  • University of Kansas Medical Center
  • CCOP - Wichita
  • Veterans Affairs Medical Center - Wichita
  • MBCCOP - LSU Health Sciences Center
  • Louisiana State University Health Sciences Center - Shreveport
  • University of Michigan Comprehensive Cancer Center
  • Barbara Ann Karmanos Cancer Institute
  • Veterans Affairs Medical Center - Detroit
  • CCOP - Grand Rapids
  • Herbert Irving Comprehensive Cancer Center at Columbia University
  • James P. Wilmot Cancer Center at University of Rochester Medical Center
  • Oregon Cancer Institute
  • Veterans Affairs Medical Center - Portland
  • Hollings Cancer Center at Medical University of South Carolina
  • CCOP - Upstate Carolina
  • Danville Radiation Therapy Center
  • Harrington Cancer Center
  • Veterans Affairs Medical Center - Amarillo
  • Brooke Army Medical Center
  • University of Texas Health Science Center at San Antonio
  • Veterans Affairs Medical Center - San Antonio (Murphy)
  • CCOP - Scott and White Hospital
  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
  • Veterans Affairs Medical Center - Seattle

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 6, 2001
Last Updated
June 20, 2013
Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00016393
Brief Title
BMS-247550 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2004
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ixabepilone

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maha Hadi A. Hussain, MD
Organizational Affiliation
University of Michigan Rogel Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Primo N. Lara, MD
Organizational Affiliation
University of California, Davis
Facility Information:
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-0804
Country
United States
Facility Name
University of California Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
CCOP - Atlanta Regional
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342-1701
Country
United States
Facility Name
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7390
Country
United States
Facility Name
CCOP - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214-3882
Country
United States
Facility Name
Veterans Affairs Medical Center - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67218
Country
United States
Facility Name
MBCCOP - LSU Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Louisiana State University Health Sciences Center - Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130-3932
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0330
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States
Facility Name
Veterans Affairs Medical Center - Detroit
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1932
Country
United States
Facility Name
CCOP - Grand Rapids
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Herbert Irving Comprehensive Cancer Center at Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
James P. Wilmot Cancer Center at University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Oregon Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201-3098
Country
United States
Facility Name
Veterans Affairs Medical Center - Portland
City
Portland
State/Province
Oregon
ZIP/Postal Code
97207
Country
United States
Facility Name
Hollings Cancer Center at Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
CCOP - Upstate Carolina
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Danville Radiation Therapy Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Harrington Cancer Center
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Veterans Affairs Medical Center - Amarillo
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Brooke Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234-6200
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3900
Country
United States
Facility Name
Veterans Affairs Medical Center - San Antonio (Murphy)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
CCOP - Scott and White Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Veterans Affairs Medical Center - Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16314632
Citation
Hussain M, Tangen CM, Lara PN Jr, Vaishampayan UN, Petrylak DP, Colevas AD, Sakr WA, Crawford ED; Southwest Oncology Group. Ixabepilone (epothilone B analogue BMS-247550) is active in chemotherapy-naive patients with hormone-refractory prostate cancer: a Southwest Oncology Group trial S0111. J Clin Oncol. 2005 Dec 1;23(34):8724-9. doi: 10.1200/JCO.2005.02.4448.
Results Reference
result

Learn more about this trial

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

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