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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00096499
First received: November 9, 2004
Last updated: January 24, 2013
Last verified: January 2013
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Probability of PSA response [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: From date of registration to date of death due to any cause, assessed up to 3 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Probability of objective response [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: April 2005
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00096499

Locations
United States, Texas
Southwest Oncology Group
San Antonio, Texas, United States, 78245
Sponsors and Collaborators
Investigators
Principal Investigator: Tomasz Beer Southwest Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00096499     History of Changes
Other Study ID Numbers: NCI-2012-02630, SWOG-S0418, U10CA032102, CDR0000393206
Study First Received: November 9, 2004
Last Updated: January 24, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 20, 2014