Study in Women With Metastatic Breast Cancer Whose Cancer Has Gotten Worse After Anthracycline and Taxane Therapy

January 13, 2012 updated by: Pfizer

A Phase II Study Of Intravenous Edotecarin (PHA-782615) In Patients With Anthracycline- And Taxane Resistant Metastatic Breast Cancer

This international study will study how metastatic breast cancer responds to the investigational drug treatment, what are the side effects of the investigational drug when given to women with metastatic breast cancer and how often do these side effects occur. The study will also analyze how fast investigational drug and its breakdown products are cleared from the blood in these patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

65

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

  • Australia
    • Victoria
      • East Bentleigh, Victoria, Australia, 3165
        • Pfizer Investigational Site
      • Parkville, Victoria, Australia, 3050
        • Pfizer Investigational Site
  • Belgium
      • Brussel, Belgium, 1090
        • Pfizer Investigational Site
      • Charleroi, Belgium, B-6000
        • Pfizer Investigational Site
      • Haine St. Paul, Belgium, 7100
        • Pfizer Investigational Site
      • Leuven, Belgium, 3000
        • Pfizer Investigational Site
      • Wilrijk, Belgium, 2610
        • Pfizer Investigational Site
  • France
      • Dijon, France, 21034
        • Pfizer Investigational Site
      • Montpellier, France, 34059
        • Pfizer Investigational Site
      • Paris, France, 75015
        • Pfizer Investigational Site
      • Toulouse Cedex, France, 31052
        • Pfizer Investigational Site
      • Vandoeuvre Les Nancy, France, 54511
        • Pfizer Investigational Site
  • United States
    • New York
      • Manhasset, New York, United States, 11030
        • Pfizer Investigational Site
      • New York, New York, United States, 10021
        • Pfizer Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Pfizer Investigational Site
      • Cleveland, Ohio, United States, 44121
        • Pfizer Investigational Site
      • Orange Village, Ohio, United States, 44122
        • Pfizer Investigational Site
      • Westlake, Ohio, United States, 44145
        • Pfizer Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Pfizer Investigational Site

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:

  • Locally advanced or metastatic breast cancer not amenable to surgery or radiation with curative intent
  • Must have received any chemotherapy regimen in the past
  • Evidence of tumor resistance to last chemotherapy defined as progression after 6 months of previous chemotherapy for advanced disease
  • Must have measurable (by imaging techniques) disease
  • Adequate bone marrow, liver and renal function
  • Must provide evidence of informed consent and willingness and ability to comply with scheduled visits, treatment plan and study procedures.

Exclusion Criteria:

  • Received more than 2 prior chemotherapy regimens for metastatic disease
  • Received in the past another drug of the same class as the investigational drug, i.e. topoisomerase I inhibitor
  • Enrolled in another clinical intervention study
  • Pregnancy, breast feeding, fertile women refusing to use reliable contraceptive methods
  • Cardiac or thrombotic event in the last 12 months
  • Brain metastases

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 assess the anti-tumor activity of single-agent Edotecarin by determining the objective response rate

Secondary Outcome Measures

Outcome Measure
Clinical benefit
Time to treatment failure (TTF)
Overall survival (OS)
Time to tumor response (TAR)
Duration of response (DR)
Time to tumor progression (TTP)
ie, a composite profile of pain intensity
analgesic consumption and performance status (pain and analgesic consumption to be measured as described in Purohit 1994 [18]
performance status to be assessed using the Eastern Cooperative Oncology Group ([ECOG]) scale [Appendix 2]
Overall safety profile characterized by type, frequency, severity (as graded by version 2.0 of the National Cancer Institute (NCI) Common Toxicity Criteria [CTC]
[Appendix 3], timing and relationship to study therapy of adverse events and laboratory abnormalities.
Plasma pharmacokinetic parameters

Collaborators and Investigators

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

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

June 1, 2003

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

August 15, 2003

First Submitted That Met QC Criteria

August 15, 2003

First Posted (Estimate)

August 18, 2003

Study Record Updates

Last Update Posted (Estimate)

January 18, 2012

Last Update Submitted That Met QC Criteria

January 13, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EDOABC-4439-001

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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