Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Not Enrolling
Both
Neoplasm

Thank you

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:

Interventional

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:

Yes

Principal Investigator

Tomislav Dragovich, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arizona/Arizona Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

PCRT04-001

NCT ID:

NCT00226005

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

Name

Location

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