A Pilot Study of PPX in Women With Metastatic Colorectal Cancer
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of PPX (Paclitaxel Poliglumex, CT-2103) in Women With Metastatic Colorectal Cancer|
- RECIST Response [ Time Frame: Assessed Every 6 Weeks Until Patient goes off Study ] [ Designated as safety issue: No ]
- Time to progression [ Time Frame: Until Patient goes off study ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: Until Patient Goes off study ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2008|
|Study Completion Date:||July 2011|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
Paclitaxel Poliglumex 175 mg/m2 will be given over ten minutes every 3 weeks. A
Drug: Paclitaxel Poliglumex
Paclitaxel Poliglumex 175 mg/m2 will be given over ten minutes every 3 weeks.
|United States, California|
|University of Southern California (U.S.C.)/ Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||Syma Iqbal, M.D.||U.S.C. / Norris Comprehensive Cancer Center|