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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00067314
• Other study ID #: EDOABC-4439-001
• Status: Completed
• Phase: Phase 2
• First received: August 15, 2003
• Last updated: January 13, 2012
• Start date: June 2003
• Est. completion date: June 2007

Study information

• Verified date: January 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Neoplasm Metastasis
• Neoplasms

Intervention

Drug:
• Edotecarin

Locations

Country	Name	City	State
Australia	Pfizer Investigational Site	East Bentleigh	Victoria
Australia	Pfizer Investigational Site	Parkville	Victoria
Belgium	Pfizer Investigational Site	Brussel
Belgium	Pfizer Investigational Site	Charleroi
Belgium	Pfizer Investigational Site	Haine St. Paul
Belgium	Pfizer Investigational Site	Leuven
Belgium	Pfizer Investigational Site	Wilrijk
France	Pfizer Investigational Site	Dijon
France	Pfizer Investigational Site	Montpellier
France	Pfizer Investigational Site	Paris
France	Pfizer Investigational Site	Toulouse Cedex
France	Pfizer Investigational Site	Vandoeuvre Les Nancy
United States	Pfizer Investigational Site	Cleveland	Ohio
United States	Pfizer Investigational Site	Cleveland	Ohio
United States	Pfizer Investigational Site	Manhasset	New York
United States	Pfizer Investigational Site	Nashville	Tennessee
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Orange Village	Ohio
United States	Pfizer Investigational Site	Westlake	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  France, 

Outcome

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

External Links

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