Metastatic Non-hematologic Malignancies Clinical Trial
Official title:
Phase I Study of the Oral Vascular Endothelial Growth Factor Inhibitor PTK787/ZK 222584 in Combination With Paclitaxel in Patients With Advanced Solid Tumors.
PTK787/ZK 222584 is an inhibitor of VEGFR family tyrosine kinases. The primary objective of this study is to assess the safety of daily oral PTK787/ZK 222584 in combination with paclitaxel infused every 21 days. Secondary objectives include pharmacokinetic assessment of the impact of PTK787/ZK 222584 on paclitaxel metabolism and evaluation of tumor response to the investigational treatment.
- We are looking for the highest dose of Paclitaxel that can be given safely in combination with the highest safe dose of Vatalanib. Therefore, not all people will receive the same dose of the study drug. - Small groups of people will be enrolled in steps on this trial. This first group will be given a certain dose of Paclitaxel and Vatalanib. If they have few or manageable side effects, the next small group of people enrolled will receive higher doses of the study drugs. This increase in doses will continue until the study doctors find the highest dose of the drugs that can be given without causing severe or unmanageable side effects. - In this study, Vatalanib tablets are taken daily, and paclitaxel is given by three-hour intravenous infusion once every 21 days. ;