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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

August 23, 2005
January 15, 2015
July 2005
November 2006   (final data collection date for primary outcome measure)
Time To Progression (TTP) in Weeks [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
The primary objective of this Phase II trial is to assess the efficacy of PTK787/ZK 222584 in terms of PSA response, in patients with hormone-refractory prostate cancer.
Complete list of historical versions of study NCT00134355 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Evaluate the toxicity in patients treated with PTK787/ZK 222584
  • Assess overall survival in patients treated with PTK787/ZK 222584
  • Assess effect of PTK787/ZK 222584 on circulating VEGF levels in patients treated with PTK787/ZK 222584
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Drug: PTK787
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

Intervention: Drug: PTK787
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
March 2007
November 2006   (final data collection date for primary outcome measure)

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.
Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00134355
UMCC 2005.014
Yes
Not Provided
Not Provided
University of Michigan Cancer Center
University of Michigan Cancer Center
Novartis
Principal Investigator: Kathleen W. Beekman, MD The University of Michigan Comprehensive Cancer Center
University of Michigan Cancer Center
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP