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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00016393
First received: May 6, 2001
Last updated: June 20, 2013
Last verified: February 2004
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: ixabepilone
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 2001
Study Completion Date: April 2006
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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00016393

  Show 28 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Maha Hadi A. Hussain, MD University of Michigan Cancer Center
Investigator: Primo N. Lara, MD University of California, Davis
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00016393     History of Changes
Other Study ID Numbers: CDR0000068629, SWOG-S0111
Study First Received: May 6, 2001
Last Updated: June 20, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
stage IV prostate cancer
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014