Status:
COMPLETED
PTK787 in Patients With Advanced Metastatic Pancreatic Adenocarcinoma
Lead Sponsor:
Pancreatic Cancer Research Team
Conditions:
Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 s...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00226005
Start Date
December 1 2005
End Date
February 1 2010
Last Update
May 9 2012
Active Locations (7)
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1
Scottsdale Healthcare
Scottsdale, Arizona, United States, 85259
2
University of Arizona/Arizona Cancer Center
Tucson, Arizona, United States, 85724
3
Tower Hematology Oncology Medical Group
Beverly Hills, California, United States, 90211-18500
4
Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins
Baltimore, Maryland, United States, 21231