PTK787 in Patients With Advanced Metastatic Pancreatic Adenocarcinoma
Phase II Trial of PTK787/ZK222584 in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma Who Failed First-Line Gemcitabine Therapy.
1 other identifier
interventional
67
1 country
7
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2005
Typical duration for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2005
CompletedFirst Posted
Study publicly available on registry
September 26, 2005
CompletedStudy Start
First participant enrolled
December 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedMay 9, 2012
May 1, 2012
3 years
September 22, 2005
May 8, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the 6-month survival rate and time to progression in pancreatic cancer patients treated with PTK787/ZK222584.
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)
DSMC Schedule
Secondary Outcomes (3)
To assess the response rates of patients treated with PTK787/ZK222584.
DSMC Schedule
To evaluate DCE-MRI as a surrogate of response to PTK787/ZK222584 therapy in pancreatic cancer patients.
DSMC Schedule
To perform analysis of tissue, blood and plasma markers that may be helpful in assessing the likelihood of benefit from PTK787/ZK222584 therapy.
DSMC Schedule
Study Arms (1)
Vatalanib
ACTIVE COMPARATORAdministered orally, twice daily: after enrollment - first week 250 BID, second week 500 BID, then 750 BID thereafter.
Interventions
One arm: administered orally, twice daily: after enrollment - first week 250 BID, second week 500 BID, then 750 BID thereafter.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Scottsdale Healthcare
Scottsdale, Arizona, 85259, United States
University of Arizona/Arizona Cancer Center
Tucson, Arizona, 85724, United States
Tower Hematology Oncology Medical Group
Beverly Hills, California, 90211-18500, United States
Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins
Baltimore, Maryland, 21231, United States
Virginia Piper Cancer Institute/Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
South Texas Oncology and Hematology
San Antonio, Texas, 78229, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tomislav Dragovich, MD, PhD
University of Arizona/Arizona Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2005
First Posted
September 26, 2005
Study Start
December 1, 2005
Primary Completion
December 1, 2008
Study Completion
February 1, 2010
Last Updated
May 9, 2012
Record last verified: 2012-05