Prostate Cancer
Conditions
Keywords
antiangiogenesis therapy, vatalanib
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.
Interventions
DRUGPTK787
Sponsors
Novartis
University of Michigan Rogel Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time To Progression (TTP) in Weeks | 12 Months |
Secondary
| Measure | Time frame |
|---|---|
| Number of Toxicities in Patients Treated with PTK787 | 30 Days After Last Dose |
| Overall Survival | 12 Months |
Outcome results
None listed