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

January 24, 2013 updated by: National Cancer Institute (NCI)

A Phase II Study of SB-715992 (NSC-727990, IND-70273) in Taxane-Resistant Androgen-Independent Metastatic Prostate Cancer

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

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

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78245
        • Southwest Oncology Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
Other: laboratory biomarker analysis
Correlative studies
Other: pharmacological study
Correlative studies
Other Names:
  • pharmacological studies
Drug: ispinesib
Given IV
Other Names:
  • CK0238273
  • SB-715992

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Probability of PSA response
Time Frame: Up to 3 years
Up to 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: From date of registration to date of death due to any cause, assessed up to 3 years
From date of registration to date of death due to any cause, assessed up to 3 years
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
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
Probability of objective response
Time Frame: Up to 3 years
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Tomasz Beer, Southwest Oncology Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

November 9, 2004

First Submitted That Met QC Criteria

November 9, 2004

First Posted (Estimate)

November 10, 2004

Study Record Updates

Last Update Posted (Estimate)

January 25, 2013

Last Update Submitted That Met QC Criteria

January 24, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2012-02630
  • U10CA032102 (U.S. NIH Grant/Contract)
  • SWOG-S0418
  • CDR0000393206 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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