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

Phase II Evaluation of PTK787, an Oral Vascular Endothelial Growth Factor Inhibitor, in Patients With Non-Metastatic Androgen Independent Prostate Cancer

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: PTK787

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: PTK787

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time To Progression (TTP) in Weeks	12 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Toxicities in Patients Treated with PTK787	30 Days After Last Dose
Overall Survival	12 Months

Collaborators and Investigators

• Sponsor: University of Michigan Rogel Cancer Center
• Collaborators: Novartis
• Investigators: Principal Investigator: Kathleen W. Beekman, MD, The University of Michigan Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start: July 1, 2005
• Primary Completion (Actual): November 1, 2006
• Study Completion (Actual): March 1, 2007

Study Registration Dates

• First Submitted: August 23, 2005
• First Submitted That Met QC Criteria: August 23, 2005
• First Posted (Estimate): August 24, 2005

Study Record Updates

• Last Update Posted (Estimate): January 19, 2015
• Last Update Submitted That Met QC Criteria: January 15, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: antiangiogenesis therapy; vatalanib
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Vatalanib
• Other Study ID Numbers: UMCC 2005.014