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A Pilot Study of PPX in Women With Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00598247
Recruitment Status : Completed
First Posted : January 21, 2008
Last Update Posted : February 6, 2014
CTI BioPharma
ASCEND Therapeutics
Information provided by (Responsible Party):
University of Southern California

Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Colorectal Cancer Drug: Paclitaxel Poliglumex Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of PPX (Paclitaxel Poliglumex, CT-2103) in Women With Metastatic Colorectal Cancer
Study Start Date : January 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

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.

Primary Outcome Measures :
  1. RECIST Response [ Time Frame: Assessed Every 6 Weeks Until Patient goes off Study ]

Secondary Outcome Measures :
  1. Time to progression [ Time Frame: Until Patient goes off study ]
  2. Toxicity [ Time Frame: Until Patient Goes off study ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00598247

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United States, California
University of Southern California (U.S.C.)/ Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
CTI BioPharma
ASCEND Therapeutics
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Principal Investigator: Syma Iqbal, M.D. U.S.C. / Norris Comprehensive Cancer Center

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Responsible Party: University of Southern California Identifier: NCT00598247    
Other Study ID Numbers: 3C-07-3
First Posted: January 21, 2008    Key Record Dates
Last Update Posted: February 6, 2014
Last Verified: February 2014
Keywords provided by University of Southern California:
Colon Cancer Rectal Colorectal Women
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Paclitaxel poliglumex
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action