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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Evaluation of PTK787, an Oral Vascular Endothelial Growth Factor Inhibitor, in Patients With Non-Metastatic Androgen Independent Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: PTK787


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PTK787<br>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 | Drug: PTK787<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time To Progression (TTP) in Weeks |  | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Toxicities in Patients Treated with PTK787 |  | 30 Days After Last Dose | 
| Overall Survival |  | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antiangiogenesis therapy, vatalanib