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

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00134355
First received: August 23, 2005
Last updated: January 15, 2015
Last verified: January 2015
  Purpose

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 Intervention Phase
Prostate Cancer
Drug: PTK787
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • Time To Progression (TTP) in Weeks [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Toxicities in Patients Treated with PTK787 [ Time Frame: 30 Days After Last Dose ] [ Designated as safety issue: Yes ]
  • Overall Survival [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: July 2005
Study Completion Date: March 2007
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134355

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

No publications provided

Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00134355     History of Changes
Other Study ID Numbers: UMCC 2005.014
Study First Received: August 23, 2005
Last Updated: January 15, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Michigan Cancer Center:
antiangiogenesis therapy
vatalanib

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Vatalanib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on July 28, 2015