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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00067314

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 II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Edotecarin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Study Of Intravenous Edotecarin (PHA-782615) In Patients With Anthracycline- And Taxane Resistant Metastatic Breast Cancer

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

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

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

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	EDOABC-4439-001
Study First Received:	August 15, 2003
Last Updated:	August 22, 2007
ClinicalTrials.gov Identifier:	NCT00067314 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Skin Diseases
Neoplasm Metastasis
Breast Neoplasms
Taxane
Breast Diseases

Additional relevant MeSH terms:

Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site

Skin Diseases
Neoplasm Metastasis
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009