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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00134355
• Other study ID #: UMCC 2005.014
• Status: Completed
• Phase: Phase 2
• First received: August 23, 2005
• Last updated: January 15, 2015
• Start date: July 2005
• Est. completion date: March 2007

Study information

• Verified date: January 2015
• Source: University of Michigan Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: March 2007
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• PTK787

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan Cancer Center	Novartis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time To Progression (TTP) in Weeks		12 Months	No
Secondary	Number of Toxicities in Patients Treated with PTK787		30 Days After Last Dose	Yes
Secondary	Overall Survival		12 Months	No