NCT00598247

A Pilot Study of PPX in Women With Metastatic Colorectal Cancer

A Pilot Study of PPX (Paclitaxel Poliglumex, CT-2103) in Women With Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study uses the drug PPX (also called Xyotax and CT-2103) in women with advanced colorectal cancer. PPX is an experimental drug that has not been approved by the Food and Drug Administration (FDA). PPX has been shown in the laboratory and in studies in humans to cause some cancer cells to die and some tumors to shrink. Women in some studies with PPX have been shown to live longer than the men that receive the drug. Some studies in humans suggest that estrogen (a hormone found in women) may protect women from getting colorectal cancer and allow women that do get colorectal cancer to live longer than men that do. The purpose of this study is to see if women with colorectal cancer and a certain level of estrogen experience tumor shrinkage after they receive the drug PPX. This study will also study genes (genes are the cell's blueprint) in participant's tumors and in their blood. Several genes can affect how people's bodies react to the cancer drugs. We want to see if these predict response to the study drugs.

Conditions

• Advanced Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel Poliglumex	Paclitaxel Poliglumex 175 mg/m2 will be given over ten minutes every 3 weeks.

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-09-01
• Completion: 2011-07-01
• First posted: 2008-01-21
• Last updated: 2014-02-06

Locations

1 site across 1 country: United States