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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 15, 2014