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

This study has been completed.
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00148707
First received: September 7, 2005
Last updated: December 19, 2007
Last verified: December 2007
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Metastatic Breast Cancer
Drug: CT-2103 (Xyotax)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of CT-2103 in Patients With Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 45
Study Start Date: October 2004
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
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.
  Eligibility

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

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
  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: NCT00148707

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Investigators
Principal Investigator: Lawrence N. Shulman, MD Dana-Farber Cancer Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00148707     History of Changes
Other Study ID Numbers: 04-299
Study First Received: September 7, 2005
Last Updated: December 19, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
Metastatic Breast Cancer
HER2-negative Breast Cancer
CT-2103
Xyotax

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 24, 2014