SB-715992 in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Docetaxel or Paclitaxel

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00096499
Recruitment Status : Completed
First Posted : November 10, 2004
Last Update Posted : January 25, 2013
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
Drugs used in chemotherapy, such as SB-715992, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well SB-715992 works in treating patients with metastatic prostate cancer that did not respond to docetaxel or paclitaxel

Condition or disease Intervention/treatment Phase
Adenocarcinoma of the Prostate Recurrent Prostate Cancer Stage IV Prostate Cancer Drug: ispinesib Other: pharmacological study Other: laboratory biomarker analysis Phase 2

Detailed Description:


I. Determine the prostate-specific antigen response to SB-715992 in patients with hormone-refractory, androgen-independent metastatic prostate cancer that failed prior taxane-based chemotherapy.


I. Determine the median overall survival and median progression-free survival of patients treated with this drug.

II. Determine the objective response rate (confirmed and unconfirmed, complete and partial response) in patients with measurable disease treated with this drug.

III. Determine the qualitative and quantitative toxic effects of this drug in these patients.

IV. Determine, preliminarily, the pharmacokinetics and mechanism of activity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 1.3-2.7 months.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of SB-715992 (NSC-727990, IND-70273) in Taxane-Resistant Androgen-Independent Metastatic Prostate Cancer
Study Start Date : April 2005
Actual Primary Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Treatment (ispinesib)
Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: ispinesib
Given IV
Other Names:
  • CK0238273
  • SB-715992

Other: pharmacological study
Correlative studies
Other Name: pharmacological studies

Other: laboratory biomarker analysis
Correlative studies

Primary Outcome Measures :
  1. Probability of PSA response [ Time Frame: Up to 3 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: From date of registration to date of death due to any cause, assessed up to 3 years ]
  2. Progression-free survival [ Time Frame: From date of registration to date of first observation of progressive disease, symptomatic deterioration, or death due to any cause, assessed up to 3 years ]
  3. Probability of objective response [ Time Frame: Up to 3 years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the prostate

    • Metastatic disease (N1 and/or M1)
    • Unresponsive or refractory to androgen-deprivation therapy
  • Must have received one, and only one, prior taxane-containing (docetaxel or paclitaxel) chemotherapy regimen for metastatic disease that was discontinued due to disease progression, intolerance, or patient request
  • Evidence of disease progression as defined by ≥ 1 of the following:

    • Progression of measurable disease
    • Progression of evaluable disease
    • Rising prostate-specific antigen (PSA)

      • At least 2 consecutive rises in PSA levels, each taken ≥ 7 days apart
      • PSA ≥ 5 ng/mL
  • Must have pre-study PSA > 5 ng/mL
  • Measurable or evaluable disease

    • Soft tissue disease that has been irradiated within the past 2 months is not considered measurable disease
    • Soft tissue disease that has been irradiated ≥ 2 months prior to study entry is considered measurable disease provided the lesion progressed after radiation
  • Surgical or medical castration required

    • If luteinizing hormone-releasing hormone (LHRH) agonists (leuprolide or goserelin) or LHRH antagonists (abarelix) were used, then must continue use during study therapy
  • No prior or concurrent brain metastases (treated or untreated)

    • If clinical suspicion of brain metastases, must meet the following criteria:

      • Brain CT scan or MRI negative for metastatic disease within the past 56 days
      • No new symptoms since radiographic evaluation
  • Performance status - Zubrod 0-2
  • Absolute granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9 g/dL
  • Bilirubin normal
  • SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN)
  • Creatinine ≤ 1.5 times ULN
  • Creatinine clearance ≥ 40 mL/min
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • Fertile patients must use effective contraception
  • No peripheral neuropathy ≥ grade 2
  • No prior allergic reaction attributed to compounds of similar chemical or biological composition to SB-715992
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study participation
  • No other uncontrolled illness
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated stage I or II cancer in complete remission
  • No colony-stimulating factors during the first course of study therapy
  • No concurrent anticancer biologic therapy
  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy and recovered
  • See Disease Characteristics
  • At least 4 weeks since prior flutamide or ketoconazole
  • At least 6 weeks since prior bicalutamide or nilutamide
  • No concurrent anticancer hormonal therapy except LHRH agonist or antagonist for patients who have not undergone orchiectomy
  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy and recovered
  • Prior samarium Sm 153 lexidronam pentasodium allowed
  • No prior strontium chloride Sr 89
  • No prior radiotherapy to ≥ 30% of bone marrow
  • No concurrent anticancer radiotherapy
  • See Disease Characteristics
  • At least 3 weeks since prior surgery and recovered
  • At least 2 weeks since prior and no concurrent use of any of the following CYP3A4 inhibitors or inducers:

    • Clarithromycin
    • Erythromycin
    • Troleandomycin
    • Rifampin
    • Rifabutin
    • Rifapentine
    • Itraconazole
    • Ketoconazole
    • Fluconazole (dose > 200 mg/day)
    • Voriconazole
    • Nefazodone
    • Fluvoxamine
    • Verapamil
    • Diltiazem
    • Grapefruit juice
    • Bitter orange
    • Phenytoin
    • Carbamazepine
    • Phenobarbital
    • Oxcarbazepine
    • Hypericum perforatum (St. John's wort)
    • Modafinil
  • At least 6 months since prior and no concurrent amiodarone
  • No other investigational drugs for 4 weeks before, during, and for 2 weeks after study therapy
  • No other concurrent anticancer cytotoxic therapy
  • No other concurrent anticancer therapy
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • Concurrent enrollment on SWOG-9205 (central prostate cancer serum repository protocol) allowed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00096499

United States, Texas
Southwest Oncology Group
San Antonio, Texas, United States, 78245
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Tomasz Beer Southwest Oncology Group

Responsible Party: National Cancer Institute (NCI) Identifier: NCT00096499     History of Changes
Other Study ID Numbers: NCI-2012-02630
U10CA032102 ( U.S. NIH Grant/Contract )
CDR0000393206 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: November 10, 2004    Key Record Dates
Last Update Posted: January 25, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type