A Pilot Study of PPX in Women With Metastatic Colorectal Cancer

This study has been completed.
Sponsor:
Collaborators:
CTI BioPharma
ASCEND Therapeutics
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT00598247
First received: January 10, 2008
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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 Phase
Advanced Colorectal Cancer
Drug: Paclitaxel Poliglumex
Phase 1

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • RECIST Response [ Time Frame: Assessed Every 6 Weeks Until Patient goes off Study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 15
Study Start Date: January 2008
Study Completion Date: July 2011
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00598247

Locations
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
Investigators
Principal Investigator: Syma Iqbal, M.D. U.S.C. / Norris Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT00598247     History of Changes
Other Study ID Numbers: 3C-07-3
Study First Received: January 10, 2008
Last Updated: February 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Southern California:
Colon Cancer Rectal Colorectal Women

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014