A Pilot Study of PPX in Women With Metastatic Colorectal Cancer

February 5, 2014 updated by: University of Southern California

A Pilot Study of PPX (Paclitaxel Poliglumex, CT-2103) 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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California (U.S.C.)/ Norris Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women with histologically confirmed metastatic adenocarcinoma of the colon or rectum. The primary histologic diagnosis is sufficient if there is clear evidence by imaging and/or markers of metastatic disease sites.
  • Must have failed or are intolerant of or ineligible for CPT-11, 5-FU, oxaliplatin, bevacizumab and either cetuximab or panitumumab therapies.
  • Tumor must be accessible for biopsy or paraffin embedded tissue must be available for review.
  • SWOG performance status 0-2.
  • Estradiol levels >30 pg/mL **This may be supplemented by exogenous estrogen (by gel)
  • AGC >1,500, platelets >100,000
  • Total bilirubin < 3 x upper limit of normal, Transaminase (AST and/or ALT) < 2 x upper limit of normal or < 5 x upper limit of normal in patients with liver metastasis.
  • Patients must have a creatinine of < 1.5 x upper limit of normal or a measured or calculated creatinine clearance greater than 35 mL/min obtained within 7 days of first receiving study drug.
  • Except for cancer-related abnormalities, patients should not have unstable or pre-existing major medical conditions.
  • At least one measurable lesion according to the RECIST criteria which has not been irradiated (i.e. newly arising lesions in previously irradiated areas are accepted). Ascites, pleural effusion, and bone metastases are not considered measurable. Minimum indicator lesion size: > 10 mm measured by spiral CT or > 20mm measured by conventional techniques.
  • Have a negative serum pregnancy test within 7 days prior to initiation of chemotherapy (female patients of childbearing potential).
  • Life expectancy > 3 months.

Exclusion Criteria:

  • History of a malignancy other than colon or rectal cancer, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for five years.
  • Estradiol levels < 30 pg/mL, not responsive to supplementation.
  • History of previous thromboembolic event, unless patient is on anticoagulation therapy.
  • Grade 2 or greater neuropathy.
  • Pregnant or lactating woman. Woman or men of childbearing potential not using a reliable and appropriate contraceptive method (either a barrier or hormonal method is acceptable). Patients must agree to continue contraception for 30 days from the date of the last study drug administration. (Postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential).
  • Patients with known brain metastases, unless they are well controlled - i.e. on a stable dose of steroids or if steroid therapy has been completed.
  • Patients that have received experimental therapies or other approved bio- or chemotherapies within 30 days of study entry.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
RECIST Response
Time Frame: Assessed Every 6 Weeks Until Patient goes off Study
Assessed Every 6 Weeks Until Patient goes off Study

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to progression
Time Frame: Until Patient goes off study
Until Patient goes off study
Toxicity
Time Frame: Until Patient Goes off study
Until Patient Goes off study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

CTI BioPharma
ASCEND Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ACTUAL)

September 1, 2008

Study Completion (ACTUAL)

July 1, 2011

Study Registration Dates

First Submitted

January 10, 2008

First Submitted That Met QC Criteria

January 10, 2008

First Posted (ESTIMATE)

January 21, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

February 6, 2014

Last Update Submitted That Met QC Criteria

February 5, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3C-07-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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