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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00070031 |
RATIONALE: Drugs used in chemotherapy such as edotecarin use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well edotecarin works in treating women with locally advanced or metastatic breast cancer that has not responded to previous chemotherapy.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: edotecarin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Intravenous Edotecarin (PHA-782615) in Patients With Anthracycline- and Taxane-Refractory or Chemoresistant Metastatic Breast Cancer |
Study Start Date: | June 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter study.
Patients receive edotecarin IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months until disease progression.
PROJECTED ACCRUAL: A total of 31-65 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed primary adenocarcinoma of the breast
At least 1 unidimensionally measurable lesion
Meets 1 of the following criteria:
Previously treated with anthracycline and concurrent or sequential taxane therapy
Refractory to the most recent taxane-based chemotherapy, defined as 1 of the following:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
None of the following within the past 6 months:
Pulmonary
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
No concurrent radiotherapy during and for 5 days after study treatment
Surgery
Other
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Principal Investigator: | Andrew D. Seidman, MD | Memorial Sloan-Kettering Cancer Center |
Principal Investigator: | Clifford A. Hudis, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000329917, MSKCC-03056, PHARMACIA-EDOABC-4439-001 |
Study First Received: | October 3, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00070031 History of Changes |
Health Authority: | United States: Federal Government |
recurrent breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer |
Skin Diseases Breast Neoplasms Taxane Breast Diseases Recurrence |
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |