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

NCT ID: NCT00134355

Last Updated: 2015-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2007-03-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PTK787

PTK787:

250 mg orally twice daily x 2 wks, then 250 mg orally am, 500 mg orally pm x 1 wk, then 500 mg orally twice daily

Group Type: EXPERIMENTAL

PTK787

Intervention Type: DRUG

Interventions

PTK787

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathleen W. Beekman, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Michigan Comprehensive Cancer Center

Other Identifiers

UMCC 2005.014

Identifier Type: -

Identifier Source: org_study_id