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

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ispinesib
pharmacological study
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Prostate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Southwest Oncology Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (ispinesib)

Arm Description

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.

Outcomes

Primary Outcome Measures

Probability of PSA response

Secondary Outcome Measures

Overall survival
Progression-free survival
Probability of objective response

Full Information

First Posted
November 9, 2004
Last Updated
January 24, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00096499
Brief Title
SB-715992 in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Docetaxel or Paclitaxel
Official Title
A Phase II Study of SB-715992 (NSC-727990, IND-70273) in Taxane-Resistant Androgen-Independent Metastatic Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage IV Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (ispinesib)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ispinesib
Other Intervention Name(s)
CK0238273, SB-715992
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
pharmacological study
Other Intervention Name(s)
pharmacological studies
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Probability of PSA response
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
From date of registration to date of death due to any cause, assessed up to 3 years
Title
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
Title
Probability of objective response
Time Frame
Up to 3 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomasz Beer
Organizational Affiliation
SWOG Cancer Research Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southwest Oncology Group
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78245
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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