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

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: PTK787

• Registration Number: NCT00134355
• Lead Sponsor: University of Michigan Rogel Cancer Center

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.

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-08-23
• Study First Submitted QC: 2005-08-23
• Study First Posted: 2005-08-24
• Primary Completion: 2006-11
• Study Completion: 2007-03
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-15
• Last Update Posted: 2015-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PTK787	PTK787	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

Primary Outcome Measures

Name	Time	Method
Time To Progression (TTP) in Weeks	12 Months

Secondary Outcome Measures

Name	Time	Method
Overall Survival	12 Months
Number of Toxicities in Patients Treated with PTK787	30 Days After Last Dose