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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00016393
• Other study ID #: CDR0000068629
• Secondary ID: SWOG-S0111
• Status: Completed
• Phase: Phase 2
• First received: May 6, 2001
• Last updated: June 20, 2013
• Start date: June 2001
• Est. completion date: April 2006

Study information

• Verified date: February 2004
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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 Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• ixabepilone

Locations

Country	Name	City	State
United States	Harrington Cancer Center	Amarillo	Texas
United States	Veterans Affairs Medical Center - Amarillo	Amarillo	Texas
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	CCOP - Atlanta Regional	Atlanta	Georgia
United States	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Veterans Affairs Medical Center - Detroit	Detroit	Michigan
United States	Brooke Army Medical Center	Fort Sam Houston	Texas
United States	CCOP - Grand Rapids	Grand Rapids	Michigan
United States	Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)	Hines	Illinois
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California
United States	Danville Radiation Therapy Center	Memphis	Tennessee
United States	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana
United States	Herbert Irving Comprehensive Cancer Center at Columbia University	New York	New York
United States	Oregon Cancer Institute	Portland	Oregon
United States	Veterans Affairs Medical Center - Portland	Portland	Oregon
United States	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York
United States	University of California Davis Cancer Center	Sacramento	California
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Veterans Affairs Medical Center - San Antonio (Murphy)	San Antonio	Texas
United States	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington
United States	Veterans Affairs Medical Center - Seattle	Seattle	Washington
United States	Louisiana State University Health Sciences Center - Shreveport	Shreveport	Louisiana
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	CCOP - Scott and White Hospital	Temple	Texas
United States	CCOP - Wichita	Wichita	Kansas
United States	Veterans Affairs Medical Center - Wichita	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation