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

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan Cancer Center; University of Michigan Rogel Cancer Center
• Collaborator: Novartis
• Treatments: Androgens; Endothelial Growth Factors; Vatalanib

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.