PTK787 in Patients With Advanced Metastatic Pancreatic Adenocarcinoma
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.
|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.|
- 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)
- 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 ]
|Study Start Date:||December 2005|
|Study Completion Date:||February 2010|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Active Comparator: Vatalanib
Administered orally, twice daily: after enrollment - first week 250 BID, second week 500 BID, then 750 BID thereafter.
One arm: administered orally, twice daily: after enrollment - first week 250 BID, second week 500 BID, then 750 BID thereafter.
Other Name: bevacizumab
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00226005
|United States, Arizona|
|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|
|Principal Investigator:||Tomislav Dragovich, MD, PhD||University of Arizona/Arizona Cancer Center|