PTK787 in Patients With Advanced Metastatic Pancreatic Adenocarcinoma

Neoplasm Clinical Trial

Official title:

Phase II Trial of PTK787/ZK222584 in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma Who Failed First-Line Gemcitabine Therapy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00226005
• Other study ID #: PCRT04-001
• Status: Completed
• Phase: Phase 2
• First received: September 22, 2005
• Last updated: May 8, 2012
• Start date: December 2005
• Est. completion date: February 2010

Study information

• Verified date: May 2012
• Source: Pancreatic Cancer Research Team
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: February 2010
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Neoplasm

Intervention

Drug:
• PTK787/ZK222584
One arm: administered orally, twice daily: after enrollment - first week 250 BID, second week 500 BID, then 750 BID thereafter.

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins	Baltimore	Maryland
United States	Tower Hematology Oncology Medical Group	Beverly Hills	California
United States	Virginia Piper Cancer Institute/Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	South Texas Oncology and Hematology	San Antonio	Texas
United States	Scottsdale Healthcare	Scottsdale	Arizona
United States	University of Arizona/Arizona Cancer Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Pancreatic Cancer Research Team

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	DSMC Schedule	No
Secondary	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.	DSMC Schedule	No
Secondary	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.	DSMC Schedule	No

External Links

•   web page for the nonprofit group, Pancreatic Cancer Research Team