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

University of Michigan Rogel Cancer Center

Status and phase

Completed

Phase 2

Conditions

Prostate Cancer

Treatments

Drug: PTK787

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00134355

UMCC 2005.014

Details and patient eligibility

About

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.

Full 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.

Enrollment

5 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.