PTK787 in Patients With Advanced Metastatic Pancreatic Adenocarcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pancreatic Cancer Research Team
ClinicalTrials.gov Identifier:
NCT00226005
First received: September 22, 2005
Last updated: May 8, 2012
Last verified: May 2012
  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 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 Trial of PTK787/ZK222584 in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma Who Failed First-Line Gemcitabine Therapy.

Resource links provided by NLM:


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. [ Time Frame: DSMC Schedule ] [ Designated as safety issue: Yes ]

    The Data Safety Monitoring Board met twice yearly while the study was active (2006-2008) to review data and each of the primary and secondary objectives.

    Safety Issue: the only endpoint/outcome measure that was a safety issue was the second one (safety and tolerability of PTK)



Secondary Outcome Measures:
  • To assess the response rates of patients treated with PTK787/ZK222584. [ Time Frame: DSMC Schedule ] [ Designated as safety issue: No ]
    The Data Safety Monitoring Board met twice yearly while the study was active (2006-2008) to review data and each of the primary and secondary objectives.

  • To evaluate DCE-MRI as a surrogate of response to PTK787/ZK222584 therapy in pancreatic cancer patients. [ Time Frame: DSMC Schedule ] [ Designated as safety issue: No ]
    The Data Safety Monitoring Board met twice yearly while the study was active (2006-2008) to review data and each of the primary and secondary objectives.

  • To perform analysis of tissue, blood and plasma markers that may be helpful in assessing the likelihood of benefit from PTK787/ZK222584 therapy. [ Time Frame: DSMC Schedule ] [ Designated as safety issue: No ]
    The Data Safety Monitoring Board met twice yearly while the study was active (2006-2008) to review data and each of the primary and secondary objectives.


Enrollment: 67
Study Start Date: December 2005
Study Completion Date: February 2010
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vatalanib
Administered orally, twice daily: after enrollment - first week 250 BID, second week 500 BID, then 750 BID thereafter.
Drug: PTK787/ZK222584
One arm: administered orally, twice daily: after enrollment - first week 250 BID, second week 500 BID, then 750 BID thereafter.
Other Name: bevacizumab

Detailed Description:

This is an open-label, phase II multi-center therapeutic trial investigating the efficacy and tolerability of PTK787/ZK222584 in patients with metastatic or advanced pancreatic cancer who failed first line gemcitabine-based therapy. The primary objective of this study is to evaluate the 6-month survival rate, time to progression, and tolerability of the regimen in pancreatic cancer patients treated with PTK787/ZK222584 as second-line therapy.

  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
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: NCT00226005

Locations
United States, Arizona
Scottsdale Healthcare
Scottsdale, Arizona, United States, 85259
University of Arizona/Arizona Cancer Center
Tucson, Arizona, United States, 85724
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

Additional Information:
No publications provided

Responsible Party: Pancreatic Cancer Research Team
ClinicalTrials.gov Identifier: NCT00226005     History of Changes
Other Study ID Numbers: PCRT04-001
Study First Received: September 22, 2005
Last Updated: May 8, 2012
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

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Vatalanib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on October 21, 2014