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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00067314
First received: August 15, 2003
Last updated: January 13, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Breast Neoplasms
Neoplasm Metastasis
Drug: Edotecarin
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: A Phase II Study Of Intravenous Edotecarin (PHA-782615) In Patients With Anthracycline- And Taxane Resistant Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Pfizer:

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

Estimated Enrollment: 65
Study Start Date: June 2003
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  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: NCT00067314

Locations
United States, New York
Pfizer Investigational Site
Manhasset, New York, United States, 11030
Pfizer Investigational Site
New York, New York, United States, 10021
United States, Ohio
Pfizer Investigational Site
Cleveland, Ohio, United States, 44121
Pfizer Investigational Site
Cleveland, Ohio, United States, 44106
Pfizer Investigational Site
Orange Village, Ohio, United States, 44122
Pfizer Investigational Site
Westlake, Ohio, United States, 44145
United States, Tennessee
Pfizer Investigational Site
Nashville, Tennessee, United States, 37203
Australia, Victoria
Pfizer Investigational Site
East Bentleigh, Victoria, Australia, 3165
Pfizer Investigational Site
Parkville, Victoria, Australia, 3050
Belgium
Pfizer Investigational Site
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
France
Pfizer Investigational Site
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
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00067314     History of Changes
Other Study ID Numbers: EDOABC-4439-001
Study First Received: August 15, 2003
Last Updated: January 13, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014