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BMS-247550 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
This study has been completed.
Study NCT00016393   Information provided by National Cancer Institute (NCI)
First Received: May 6, 2001   Last Updated: July 23, 2008   History of Changes

May 6, 2001
July 23, 2008
June 2001
 
 
 
Complete list of historical versions of study NCT00016393 on ClinicalTrials.gov Archive Site
 
 
 
BMS-247550 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
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.

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.

Phase II
Interventional
Treatment, Open Label
Prostate Cancer
Drug: ixabepilone
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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)
Male
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00016393
 
CDR0000068629, SWOG-S0111
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Maha Hadi A. Hussain, MD University of Michigan Cancer Center
Investigator: Primo N. Lara, MD University of California, Davis
National Cancer Institute (NCI)
February 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP