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

NCT ID: NCT00096499

Last Updated: 2013-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30

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

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.

Conditions

Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage IV Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ispinesib

Intervention Type: DRUG

Given IV

pharmacological study

Intervention Type: OTHER

Correlative studies

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

ispinesib

Given IV

Intervention Type: DRUG

pharmacological study

Correlative studies

Intervention Type: OTHER

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

CK0238273; SB-715992; pharmacological studies

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tomasz Beer

Role: PRINCIPAL_INVESTIGATOR

SWOG Cancer Research Network

Locations

Southwest Oncology Group

San Antonio, Texas, United States

Countries

United States

Other Identifiers

SWOG-S0418

Identifier Type: -

Identifier Source: secondary_id

U10CA032102

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000393206

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02630

Identifier Type: -

Identifier Source: org_study_id