Clinical trial NCT00134355: Study of PTK787 in the Treatment of Patients With Non-Metastatic Androgen Independent Prostate Cancer
Official title: Phase II Evaluation of PTK787, an Oral Vascular Endothelial Growth Factor Inhibitor, in Patients With Non-Metastatic Androgen Independent Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: antiangiogenesis therapy
vatalanib
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2005-08-24
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Time To Progression (TTP) in Weeks
timeFrame: 12 Months
Secondary outcomes:
measure: Number of Toxicities in Patients Treated with PTK787
timeFrame: 30 Days After Last Dose
measure: Overall Survival
timeFrame: 12 Months
Other outcomes:
Locations:
Study officials:
affiliation: The University of Michigan Comprehensive Cancer Center
name: Kathleen W. Beekman, MD
role: PRINCIPAL_INVESTIGATOR
References: