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PTK787 in Patients With Advanced Metastatic Pancreatic Adenocarcinoma
This study has been completed.
Sponsored by: Pancreatic Cancer Research Team
Information provided by: Pancreatic Cancer Research Team
ClinicalTrials.gov Identifier: NCT00226005
  Purpose

The purpose of this research study is to find out if an experimental drug called PTK787/ZK222584 might be effective against advanced or metastatic pancreatic cancer.

In order for tumors to grow and spread to other parts of the body, they need to have a growing blood supply. Tumor cells have been shown to produce substances that stimulate the abnormal growth of new blood vessels that allow the tumor to grow. In adults, blood vessel cells normally divide very rapidly. It is thought that PTK787/ZK222584 may interfere with the growth of new blood vessels. A drug that interferes with the growth of new blood vessels might stop tumor growth, and possibly shrink the tumor by keeping it from receiving nutrients and oxygen supplied by the blood vessels. Since normal blood vessel cells divide very rarely, it might be possible to stop tumor growth without harming normal tissues.


Condition Intervention Phase
Neoplasm
Drug: PTK787/ZK222584
Phase II

MedlinePlus related topics: Cancer Pancreatic Cancer
Drug Information available for: Gemcitabine hydrochloride Gemcitabine Vatalanib Butanedioic acid, compd. with N-(4-chlorophenyl)-4-(4-pyridinylmethyl)-1-phthalazinamine (1:1) Pancrelipase Ultrase
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase II Trial of PTK787/ZK222584 in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma Who Failed First-Line Gemcitabine Therapy.

Further study details as provided by Pancreatic Cancer Research Team:

Primary Outcome Measures:
  • To evaluate the 6-month survival rate and time to progression in pancreatic cancer patients treated with PTK787/ZK222584.
  • To assess the safety and tolerability of PTK787/ZK222584 in patients with pancreatic cancer.

Secondary Outcome Measures:
  • To assess the response rates of patients treated with PTK787/ZK222584.
  • To evaluate DCE-MRI as a surrogate of response to PTK787/ZK222584 therapy in pancreatic cancer patients.
  • To perform analysis of tissue, blood and plasma markers that may be helpful in assessing the likelihood of benefit from PTK787/ZK222584 therapy.

Estimated Enrollment: 65
Study Start Date: December 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18
  • Zubrod performance status of 0 - 2
  • Histological or cytological diagnosis of pancreatic adenocarcinoma
  • Measurable or evaluable disease determined as per RECIST criteria
  • Life expectancy > 12 weeks
  • Written informed consent
  • Patients must have failed or progressed on prior gemcitabine-based therapy for advanced or metastatic disease.

Exclusion Criteria:

  • Islet cell or neuroendocrine carcinomas of the pancreas.
  • History or presence of central nervous system disease.
  • Patients with a history of another primary malignancy < 5 years
  • Prior chemo therapy < 21 days prior to registration.
  • Prior biologic or immunotherapy < 14 days prior to registration
  • Prior full field radiotherapy < 28 days or limited field radiotherapy < 14 days prior to registration.
  • Major surgery < 28 days prior to registration.
  • Patients who have received investigational drugs < 28 days prior to registration.
  • Prior therapy with anti-VEGF agents.
  • Pleural effusion or ascites that causes respiratory compromise.
  • Female patients who are pregnant or breast feeding.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00226005

Locations
United States, Arizona
University of Arizona/Arizona Cancer Center
Tucson, Arizona, United States, 85724
Scottsdale Healthcare
Scottsdale, Arizona, United States, 85259
United States, California
Tower Hematology Oncology Medical Group
Beverly Hills, California, United States, 90211-18500
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins
Baltimore, Maryland, United States, 21231
United States, Minnesota
Virginia Piper Cancer Institute/Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
South Texas Oncology and Hematology
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Pancreatic Cancer Research Team
Investigators
Principal Investigator: Tomislav Dragovich, MD, PhD University of Arizona/Arizona Cancer Center
  More Information

web page for the nonprofit group, Pancreatic Cancer Research Team  This link exits the ClinicalTrials.gov site

Study ID Numbers: PCRT04-001
Study First Received: September 22, 2005
Last Updated: April 1, 2008
ClinicalTrials.gov Identifier: NCT00226005  
Health Authority: United States: Food and Drug Administration

Keywords provided by Pancreatic Cancer Research Team:
pancreas
adenocarcinoma
cancer
metastatic
advanced cancer
Phase II
growth factor
VEGF
angiogenesis

Study placed in the following topic categories:
Gemcitabine
Adenocarcinoma
Pancrelipase
Vatalanib
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009