Clinical trial NCT00226005: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neoplasm
Keywords: pancreas
adenocarcinoma
cancer
metastatic
advanced cancer
Phase II
growth factor
VEGF
angiogenesis
Lead sponsor: Pancreatic Cancer Research Team
Sponsor class: OTHER
First posted: 2005-09-26
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: To evaluate the 6-month survival rate and time to progression in pancreatic cancer patients treated with PTK787/ZK222584.
timeFrame: DSMC Schedule
Secondary outcomes:
measure: To assess the response rates of patients treated with PTK787/ZK222584.
timeFrame: DSMC Schedule
measure: To evaluate DCE-MRI as a surrogate of response to PTK787/ZK222584 therapy in pancreatic cancer patients.
timeFrame: DSMC Schedule
measure: To perform analysis of tissue, blood and plasma markers that may be helpful in assessing the likelihood of benefit from PTK787/ZK222584 therapy.
timeFrame: DSMC Schedule
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale Healthcare
state: Arizona
city: Tucson
country: United States
facility: University of Arizona/Arizona Cancer Center
state: Arizona
city: Beverly Hills
country: United States
facility: Tower Hematology Oncology Medical Group
state: California
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins
state: Maryland
city: Minneapolis
country: United States
facility: Virginia Piper Cancer Institute/Abbott Northwestern Hospital
state: Minnesota
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: San Antonio
country: United States
facility: South Texas Oncology and Hematology
state: Texas
Study officials:
affiliation: University of Arizona/Arizona Cancer Center
name: Tomislav Dragovich, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: