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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00067314
• Collaborator: (none)
• Enrollment: 65
• Locations: 19
• Duration (Months): 48
• Patients Per Site: 3.4
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms; Neoplasm Metastasis	Drug: Edotecarin	Phase 2

Study Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Jun 1, 2003
• Actual Primary Completion Date: Jun 1, 2007
• Actual Study Completion Date: Jun 1, 2007

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Time to tumor response (TAR) []

2. Duration of response (DR) []

3. Time to tumor progression (TTP) []

4. Time to treatment failure (TTF) []

5. Overall survival (OS) []

6. Clinical benefit []

7. ie, a composite profile of pain intensity []

8. analgesic consumption and performance status (pain and analgesic consumption to be measured as described in Purohit 1994 [18] []

9. performance status to be assessed using the Eastern Cooperative Oncology Group ([ECOG]) scale [Appendix 2] []

10. Overall safety profile characterized by type, frequency, severity (as graded by version 2.0 of the National Cancer Institute (NCI) Common Toxicity Criteria [CTC] []

11. [Appendix 3], timing and relationship to study therapy of adverse events and laboratory abnormalities. []

12. Plasma pharmacokinetic parameters []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Manhasset	New York	United States	11030
2	Pfizer Investigational Site	New York	New York	United States	10021
3	Pfizer Investigational Site	Cleveland	Ohio	United States	44106
4	Pfizer Investigational Site	Cleveland	Ohio	United States	44121
5	Pfizer Investigational Site	Orange Village	Ohio	United States	44122
6	Pfizer Investigational Site	Westlake	Ohio	United States	44145
7	Pfizer Investigational Site	Nashville	Tennessee	United States	37203
8	Pfizer Investigational Site	East Bentleigh	Victoria	Australia	3165
9	Pfizer Investigational Site	Parkville	Victoria	Australia	3050
10	Pfizer Investigational Site	Brussel		Belgium	1090
11	Pfizer Investigational Site	Charleroi		Belgium	B-6000
12	Pfizer Investigational Site	Haine St. Paul		Belgium	7100
13	Pfizer Investigational Site	Leuven		Belgium	3000
14	Pfizer Investigational Site	Wilrijk		Belgium	2610
15	Pfizer Investigational Site	Dijon		France	21034
16	Pfizer Investigational Site	Montpellier		France	34059
17	Pfizer Investigational Site	Paris		France	75015
18	Pfizer Investigational Site	Toulouse Cedex		France	31052
19	Pfizer Investigational Site	Vandoeuvre Les Nancy		France	54511

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00067314
• Other Study ID Numbers: EDOABC-4439-001
• First Posted: Aug 18, 2003
• Last Update Posted: Jan 18, 2012
• Last Verified: Jan 1, 2012

• Additional relevant MeSH terms: Neoplasms; Neoplasm Metastasis; Breast Neoplasms

Study Results

No Results Posted as of Jan 18, 2012