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