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

Phase 2
18 Years
Not Enrolling

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Trial Information

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

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.

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.

Type of Study:


Study Design:

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

Outcome Measure:

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

Outcome 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)

Outcome Time Frame:

DSMC Schedule

Safety Issue:


Principal Investigator

Tomislav Dragovich, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arizona/Arizona Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

December 2005

Completion Date:

February 2010

Related Keywords:

  • Neoplasm
  • pancreas
  • adenocarcinoma
  • cancer
  • metastatic
  • advanced cancer
  • Phase II
  • growth factor
  • VEGF
  • angiogenesis
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Neoplasms



South Texas Oncology and HematologySan Antonio, Texas  78229
Tower Hematology Oncology Medical GroupLos Angeles, California  90048
Scottsdale HealthcareScottsdale, Arizona  85251
Sarah Cannon Research InstituteNashville, Tennessee  37203
University of Arizona/Arizona Cancer CenterTucson, Arizona  85724
Sidney Kimmel Comprehensive Cancer Center/Johns HopkinsBaltimore, Maryland  21231
Virginia Piper Cancer Institute/Abbott Northwestern HospitalMinneapolis, Minnesota  55407