Study in Women With Metastatic Breast Cancer Whose Cancer Has Gotten Worse After Anthracycline and Taxane Therapy
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00067314
First received: August 15, 2003
Last updated: January 13, 2012
Last verified: January 2012
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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
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:
|
Breast Neoplasms Neoplasms Neoplasm Metastasis Neoplasms by Site |
Breast Diseases Skin Diseases Neoplastic Processes Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013