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Sponsors and Collaborators: |
USC/Norris Comprehensive Cancer Center Cell Therapeutics ASCEND Therapeutics |
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Information provided by: | USC/Norris Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT00598247 |
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.
Condition | Intervention |
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Advanced Colorectal Cancer |
Drug: Paclitaxel Poliglumex |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | A Pilot Study of PPX (Paclitaxel Poliglumex, CT-2103) in Women With Metastatic Colorectal Cancer |
Estimated Enrollment: | 15 |
Study Start Date: | January 2008 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Paclitaxel Poliglumex 175 mg/m2 will be given over ten minutes every 3 weeks. A
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Drug: Paclitaxel Poliglumex
Paclitaxel Poliglumex 175 mg/m2 will be given over ten minutes every 3 weeks.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Responsible Party: | University of Southern California (U.S.C.)/ Norris Comprehensive Cancer Center ( Syma Iqbal, M.D. ) |
Study ID Numbers: | 3C-07-3 |
Study First Received: | January 10, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00598247 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Colon Cancer Rectal Colorectal Women |
Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Antimitotic Agents Intestinal Diseases Rectal Diseases Intestinal Neoplasms |
Digestive System Diseases Paclitaxel Tubulin Modulators Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic Colorectal Neoplasms |
Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Mitosis Modulators Colonic Diseases Antimitotic Agents Intestinal Diseases Rectal Diseases Pharmacologic Actions |
Intestinal Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Paclitaxel Therapeutic Uses Tubulin Modulators Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic Colorectal Neoplasms |