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

Primary Purpose

Breast Neoplasms, Neoplasm Metastasis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Edotecarin
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to tumor response (TAR)
Duration of response (DR)
Time to tumor progression (TTP)
Time to treatment failure (TTF)
Overall survival (OS)
Clinical benefit
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

Full Information

First Posted
August 15, 2003
Last Updated
January 13, 2012
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00067314
Brief Title
Study in Women With Metastatic Breast Cancer Whose Cancer Has Gotten Worse After Anthracycline and Taxane Therapy
Official Title
A Phase II Study Of Intravenous Edotecarin (PHA-782615) In Patients With Anthracycline- And Taxane Resistant Metastatic Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Neoplasm Metastasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
65 (false)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Pfizer Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Pfizer Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44121
Country
United States
Facility Name
Pfizer Investigational Site
City
Orange Village
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Pfizer Investigational Site
City
Westlake
State/Province
Ohio
ZIP/Postal Code
44145
Country
United States
Facility Name
Pfizer Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Pfizer Investigational Site
City
East Bentleigh
State/Province
Victoria
ZIP/Postal Code
3165
Country
Australia
Facility Name
Pfizer Investigational Site
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Pfizer Investigational Site
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Charleroi
ZIP/Postal Code
B-6000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Haine St. Paul
ZIP/Postal Code
7100
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Dijon
ZIP/Postal Code
21034
Country
France
Facility Name
Pfizer Investigational Site
City
Montpellier
ZIP/Postal Code
34059
Country
France
Facility Name
Pfizer Investigational Site
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Pfizer Investigational Site
City
Toulouse Cedex
ZIP/Postal Code
31052
Country
France
Facility Name
Pfizer Investigational Site
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=EDOABC-4439-001&StudyName=Study%20in%20Women%20with%20Metastatic%20Breast%20Cancer%20whose%20Cancer%20has%20Gotten%20Worse%20after%20Anthracycline%20and%20Taxane%20Therapy
Description
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Study in Women With Metastatic Breast Cancer Whose Cancer Has Gotten Worse After Anthracycline and Taxane Therapy

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