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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00134355
Recruitment Status : Completed
First Posted : August 24, 2005
Last Update Posted : January 19, 2015
Information provided by (Responsible Party):
University of Michigan Cancer Center

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: PTK787 Phase 2

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  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Evaluation of PTK787, an Oral Vascular Endothelial Growth Factor Inhibitor, in Patients With Non-Metastatic Androgen Independent Prostate Cancer
Study Start Date : July 2005
Actual Primary Completion Date : November 2006
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Time To Progression (TTP) in Weeks [ Time Frame: 12 Months ]

Secondary Outcome Measures :
  1. Number of Toxicities in Patients Treated with PTK787 [ Time Frame: 30 Days After Last Dose ]
  2. Overall Survival [ Time Frame: 12 Months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00134355

Sponsors and Collaborators
University of Michigan Cancer Center
Principal Investigator: Kathleen W. Beekman, MD The University of Michigan Comprehensive Cancer Center

Responsible Party: University of Michigan Cancer Center Identifier: NCT00134355     History of Changes
Other Study ID Numbers: UMCC 2005.014
First Posted: August 24, 2005    Key Record Dates
Last Update Posted: January 19, 2015
Last Verified: January 2015

Keywords provided by University of Michigan Cancer Center:
antiangiogenesis therapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Endothelial Growth Factors
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Growth Substances
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action