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

NCT00134355 | Completed Phase 2 DMC

• 1 other identifier: UMCC 2005.014
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prostate Cancer

Keywords

antiangiogenesis therapy; vatalanib

Outcome Measures

Primary Outcomes (1)

• Time To Progression (TTP) in Weeks

  12 Months

Secondary Outcomes (2)

• Number of Toxicities in Patients Treated with PTK787

  30 Days After Last Dose

• Overall Survival

  12 Months

Study Arms (1)

PTK787

EXPERIMENTAL

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

Interventions

PTK787 DRUG

PTK787

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• Novartis: collaborator

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

vatalanib

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Kathleen W. Beekman, MD

  The University of Michigan Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2005
• First Posted: August 24, 2005
• Study Start: July 1, 2005
• Primary Completion: November 1, 2006
• Study Completion: March 1, 2007
• Last Updated: January 19, 2015

Record last verified: 2015-01