PTK787 in Patients With Advanced Metastatic Pancreatic Adenocarcinoma

Sponsor

Pancreatic Cancer Research Team (Other)

Overall Status

Completed

CT.gov ID

NCT00226005

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

9.6

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasm	Drug: PTK787/ZK222584	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

67 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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.

Study Start Date :

Dec 1, 2005

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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 Names: bevacizumab

Arm

Intervention/Treatment

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 Names:

bevacizumab

Outcome Measures

Primary Outcome Measures

To evaluate the 6-month survival rate and time to progression in pancreatic cancer patients treated with PTK787/ZK222584. [DSMC Schedule]
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. [DSMC Schedule]
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. [DSMC Schedule]
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. [DSMC Schedule]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
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
5	Virginia Piper Cancer Institute/Abbott Northwestern Hospital	Minneapolis	Minnesota	United States	55407
6	Sarah Cannon Research Institute	Nashville	Tennessee	United States	37203
7	South Texas Oncology and Hematology	San Antonio	Texas	United States	78229