Back to resultsPTK787 in Patients With Advanced Metastatic Pancreatic Adenocarcinoma
Primary Purpose
Neoplasm
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PTK787/ZK222584
Sponsored by
About this trial
This is an interventional treatment trial for Neoplasm focused on measuring pancreas, adenocarcinoma, cancer, metastatic, advanced cancer, Phase II, growth factor, VEGF, angiogenesis
Eligibility 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.
Sites / Locations
- Scottsdale Healthcare
- University of Arizona/Arizona Cancer Center
- Tower Hematology Oncology Medical Group
- Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins
- Virginia Piper Cancer Institute/Abbott Northwestern Hospital
- Sarah Cannon Research Institute
- South Texas Oncology and Hematology
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
Vatalanib
Arm Description
Administered orally, twice daily: after enrollment - first week 250 BID, second week 500 BID, then 750 BID thereafter.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
To assess the response rates of 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.
To evaluate DCE-MRI as a surrogate of response to PTK787/ZK222584 therapy in pancreatic cancer patients.
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.
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.
Full Information
NCT ID
NCT00226005
First Posted
September 22, 2005
Last Updated
May 8, 2012
Sponsor
Pancreatic Cancer Research Team
1. Study Identification
Unique Protocol Identification Number
NCT00226005
Brief Title
PTK787 in Patients With Advanced Metastatic Pancreatic Adenocarcinoma
Official Title
Phase II Trial of PTK787/ZK222584 in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma Who Failed First-Line Gemcitabine Therapy.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pancreatic Cancer Research Team
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasm
Keywords
pancreas, adenocarcinoma, cancer, metastatic, advanced cancer, Phase II, growth factor, VEGF, angiogenesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vatalanib
Arm Type
Active Comparator
Arm Description
Administered orally, twice daily: after enrollment - first week 250 BID, second week 500 BID, then 750 BID thereafter.
Intervention Type
Drug
Intervention Name(s)
PTK787/ZK222584
Other Intervention Name(s)
bevacizumab
Intervention Description
One arm: administered orally, twice daily: after enrollment - first week 250 BID, second week 500 BID, then 750 BID thereafter.
Primary Outcome Measure Information:
Title
To evaluate the 6-month survival rate and time to progression in pancreatic cancer patients treated with PTK787/ZK222584.
Description
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)
Time Frame
DSMC Schedule
Secondary Outcome Measure Information:
Title
To assess the response rates of patients treated with PTK787/ZK222584.
Description
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.
Time Frame
DSMC Schedule
Title
To evaluate DCE-MRI as a surrogate of response to PTK787/ZK222584 therapy in pancreatic cancer patients.
Description
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.
Time Frame
DSMC Schedule
Title
To perform analysis of tissue, blood and plasma markers that may be helpful in assessing the likelihood of benefit from PTK787/ZK222584 therapy.
Description
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.
Time Frame
DSMC Schedule
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomislav Dragovich, MD, PhD
Organizational Affiliation
University of Arizona/Arizona Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scottsdale Healthcare
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
University of Arizona/Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Tower Hematology Oncology Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211-18500
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Virginia Piper Cancer Institute/Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
South Texas Oncology and Hematology
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
PTK787 in Patients With Advanced Metastatic Pancreatic Adenocarcinoma
We'll reach out to this number within 24 hrs