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Study of PTK787 in the Treatment of Patients With Non-Metastatic Androgen Independent Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
PTK787
Sponsored by
University of Michigan Rogel Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring antiangiogenesis therapy, vatalanib

Eligibility Criteria

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

Inclusion Criteria: Histologic or cytologic diagnosis of prostate cancer No evidence of metastatic disease PSA-only progression despite androgen depravation therapy and antiandrogen withdrawal Patients must maintain castrate levels of testosterone (<50ng/mL) or continue on LHRH ( Luteinizing Hormone-releasing Hormone) analog therapy. ECOG (Eastern Cooperative Oncology Group) performance status of 0-2 (A measure of quality of life where 0 represents asymptomatic and 5 represents death) No prior anti-VEGF therapy is allowed No investigational or commercial agents or therapies other than LHRH agonists/antagonists may be administered concurrently with intent to treat the patient's malignancy Age greater than or equal to 18 years Life expectancy greater than 6 months Normal organ and marrow function obtained within 14 days prior to registration Must use adequate contraception prior to study entry and for the duration of study participation. Exclusion Criteria: Patients may continue on a daily multivitamin, but all other herbal or alternative food supplements must be discontinued before registration. Patients must be on stable doses of bisphosphonates which have been started no less than 6 weeks prior to protocol therapy. Uncontrolled incurrent illness Patients with a "currently active" second malignancy are not eligible. Major surgery less than or equal to 4 weeks prior to randomization Prior chemotherapy less than or equal to 3 weeks prior to registration Prior biologic or immunotherapy less than or equal to 2 weeks prior to registration Prior investigational drugs of any kind less than or equal to 4 weeks prior to registration Patients who have had full field radiotherapy less than or equal to 4 weeks or limited field radiotherapy equal or less than 2 weeks prior to registration. Patients must not be on nonsteroidal antiandrogen blockade. Patients must have no evidence of disease on bone scan or computed tomography (CT) scan of the abdomen/pelvis.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    PTK787

    Arm Description

    PTK787: 250 mg orally twice daily x 2 wks, then 250 mg orally am, 500 mg orally pm x 1 wk, then 500 mg orally twice daily

    Outcomes

    Primary Outcome Measures

    Time To Progression (TTP) in Weeks

    Secondary Outcome Measures

    Number of Toxicities in Patients Treated with PTK787
    Overall Survival

    Full Information

    First Posted
    August 23, 2005
    Last Updated
    January 15, 2015
    Sponsor
    University of Michigan Rogel Cancer Center
    Collaborators
    Novartis
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00134355
    Brief Title
    Study of PTK787 in the Treatment of Patients With Non-Metastatic Androgen Independent Prostate Cancer
    Official Title
    Phase II Evaluation of PTK787, an Oral Vascular Endothelial Growth Factor Inhibitor, in Patients With Non-Metastatic Androgen Independent Prostate Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2005 (undefined)
    Primary Completion Date
    November 2006 (Actual)
    Study Completion Date
    March 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Michigan Rogel Cancer Center
    Collaborators
    Novartis

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate PTK787/ZK 222584, a drug that blocks new blood vessel growth, in the treatment of patients with non-metastatic androgen independent prostate cancer. This study will assess the safety and tolerability of PTK787/ZK 222584, and evaluate serum vascular endothelial growth factor (VEGF) levels.
    Detailed Description
    This is an open-label, phase II trial of PTK787/ZK 222584. Patients will receive 750 mg daily for one week, 1000 mg daily for the second week, and then 1250 mg per day thereafter. Response Assessment: In the absence of toxicity or clinical progression, patients will remain in the study until their PSA (Prostate-specific Antigen) has doubled from pretreatment baseline.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer
    Keywords
    antiangiogenesis therapy, vatalanib

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    PTK787
    Arm Type
    Experimental
    Arm Description
    PTK787: 250 mg orally twice daily x 2 wks, then 250 mg orally am, 500 mg orally pm x 1 wk, then 500 mg orally twice daily
    Intervention Type
    Drug
    Intervention Name(s)
    PTK787
    Primary Outcome Measure Information:
    Title
    Time To Progression (TTP) in Weeks
    Time Frame
    12 Months
    Secondary Outcome Measure Information:
    Title
    Number of Toxicities in Patients Treated with PTK787
    Time Frame
    30 Days After Last Dose
    Title
    Overall Survival
    Time Frame
    12 Months

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Histologic or cytologic diagnosis of prostate cancer No evidence of metastatic disease PSA-only progression despite androgen depravation therapy and antiandrogen withdrawal Patients must maintain castrate levels of testosterone (<50ng/mL) or continue on LHRH ( Luteinizing Hormone-releasing Hormone) analog therapy. ECOG (Eastern Cooperative Oncology Group) performance status of 0-2 (A measure of quality of life where 0 represents asymptomatic and 5 represents death) No prior anti-VEGF therapy is allowed No investigational or commercial agents or therapies other than LHRH agonists/antagonists may be administered concurrently with intent to treat the patient's malignancy Age greater than or equal to 18 years Life expectancy greater than 6 months Normal organ and marrow function obtained within 14 days prior to registration Must use adequate contraception prior to study entry and for the duration of study participation. Exclusion Criteria: Patients may continue on a daily multivitamin, but all other herbal or alternative food supplements must be discontinued before registration. Patients must be on stable doses of bisphosphonates which have been started no less than 6 weeks prior to protocol therapy. Uncontrolled incurrent illness Patients with a "currently active" second malignancy are not eligible. Major surgery less than or equal to 4 weeks prior to randomization Prior chemotherapy less than or equal to 3 weeks prior to registration Prior biologic or immunotherapy less than or equal to 2 weeks prior to registration Prior investigational drugs of any kind less than or equal to 4 weeks prior to registration Patients who have had full field radiotherapy less than or equal to 4 weeks or limited field radiotherapy equal or less than 2 weeks prior to registration. Patients must not be on nonsteroidal antiandrogen blockade. Patients must have no evidence of disease on bone scan or computed tomography (CT) scan of the abdomen/pelvis.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kathleen W. Beekman, MD
    Organizational Affiliation
    The University of Michigan Comprehensive Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Study of PTK787 in the Treatment of Patients With Non-Metastatic Androgen Independent Prostate Cancer

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