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A Pilot Study of PPX in Women With Metastatic Colorectal Cancer

NCT00598247 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2014-02-06

No results posted yet for this study

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

DRUG

Paclitaxel Poliglumex

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

Sponsors & Collaborators

  • CTI BioPharma

    collaborator INDUSTRY

  • ASCEND Therapeutics

    collaborator INDUSTRY

  • University of Southern California

    lead OTHER

Principal Investigators

  • Syma Iqbal, M.D. · U.S.C. / Norris Comprehensive Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2008-09-30
Completion
2011-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00598247 on ClinicalTrials.gov