Study of Xyotax (CT-2103) in Patients With Metastatic Breast Cancer

December 19, 2007 updated by: Dana-Farber Cancer Institute

Phase II Study of CT-2103 in Patients With Metastatic Breast Cancer

The purpose of this study is to collect information on what effects (good or bad) CT-2103 (Xyotax) has on breast cancer as well as any side effects the drug may cause.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • Patients will be given CT-2103 intravenously every 3 weeks. One week after the first dose of CT-2103 a physical exam, blood work and assessment of any side effects will be performed.
  • Prior to each injection of CT-2103, a physical exam, blood work and assessment of any side effects will be performed (every 3 weeks).
  • Every 6 weeks the patient's cancer will be re-evaluated with either a CT scan or MRI to determine whether the treatment is working.
  • Additional blood work will be performed once per week after the first two doses of CT-2103.
  • The participation in this study will last at least 2 cycles (6 weeks), however patients may remain on the study as long as there is no disease progression, and they are able to tolerate the study drug without severe side effects.

Study Type

Interventional

Enrollment

45

Phase

  • Phase 2

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
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02115
        • Beth Israel Deaconess Medical 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

All

Description

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of invasive breast cancer, Stage IV disease
  • Age greater than 18 years
  • At least one measurable target lesion as defined by RECIST that has not been previously treated with local therapy
  • HER2-negative breast cancer
  • Up to one prior chemotherapy for advanced or metastatic disease
  • ECOG performance status 0-1
  • Life expectancy > 12 weeks
  • Adequate liver and bone marrow function: AST < 2.5 x ULN; Bilirubin < 1.5 x ULN; ANC > 1,500/ul; platelet count > 100,000/ul; normal PT and PTT
  • At least 2 weeks since prior radiation and recovered from treatment-related toxicity

Exclusion Criteria:

  • Prior taxanes for treatment of metastatic disease
  • Pregnant of breast-feeding women
  • HER2-positive breast cancer
  • More than 1 prior chemotherapy regimen for metastatic disease
  • Untreated brain metastases
  • Concurrent radiotherapy or investigational drug
  • Prior bone marrow or stem cell transplant
  • History of other malignancy within the last 5 years, not including curatively-treated carcinoma in situ of the cervix or non-melanoma skin cancer
  • Uncontrolled infection
  • Active bleeding, or history of bleeding requiring transfusion
  • Active cardiac disease
  • Serious medical or psychiatric illness

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 Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To evaluate the response to CT02103 as first or second-line treatment in patients with metastatic breast cancer.

Secondary Outcome Measures

Outcome Measure
To evaluate the side effects of CT-2103 in patients with metastatic breast cancer
to evaluate the proportion of patients that have complete or partial response or stable disease at 4 months
to determine the time to progression and overall survival of patients treated with CT2103.

Collaborators and Investigators

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

Sponsor

Dana-Farber Cancer Institute

Collaborators

Beth Israel Deaconess Medical Center
Brigham and Women's Hospital

Investigators

  • Principal Investigator: Lawrence N. Shulman, MD, Dana-Farber Cancer Institute

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

October 1, 2004

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 8, 2005

Study Record Updates

Last Update Posted (Estimate)

December 21, 2007

Last Update Submitted That Met QC Criteria

December 19, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-299

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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