Status:
COMPLETED
Study of PTK787 in the Treatment of Patients With Non-Metastatic Androgen Independent Prostate Cancer
Lead Sponsor:
University of Michigan Rogel Cancer Center
Collaborating Sponsors:
Novartis
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00134355
Start Date
July 1 2005
End Date
March 1 2007
Last Update
January 19 2015
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