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Sponsors and Collaborators: |
Barbara Ann Karmanos Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00096109 |
RATIONALE: Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin (17-AAG), work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well 17-AAG works in treating women with refractory locally advanced or metastatic breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: tanespimycin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Clinical Trial Of 17-Allylamino-17-Demethoxygeldanamycin (17-AAG) In Chemotherapy Refractory Metastatic Breast Cancer |
Estimated Enrollment: | 37 |
Study Start Date: | September 2004 |
Estimated Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive 17-N-allylamino-17-demethoxygeldanamycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed at day 30, every 10-12 weeks until disease progression, and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 14 months.
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 ≥ 2 cm by conventional techniques OR ≥ 1 cm by MRI or spiral CT scan
No known brain or leptomeningeal metastases requiring active therapy
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Performance status
Sex
Menopausal status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
No symptomatic pulmonary disease including any of the following:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Hawaii | |
Kapiolani Medical Center for Women and Children | |
Honolulu, Hawaii, United States, 96913 | |
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | |
Detroit, Michigan, United States, 48201-1379 | |
Weisberg Cancer Treatment Center | |
Detroit, Michigan, United States, 48334 | |
United States, Ohio | |
Case Comprehensive Cancer Center | |
Cleveland, Ohio, United States, 44106-5065 |
Study Chair: | Elaina M. Gartner, MD | Barbara Ann Karmanos Cancer Institute |
Study ID Numbers: | CDR0000391198, WSU-C-2803, NCI-6552 |
Study First Received: | November 9, 2004 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00096109 |
Health Authority: | United States: Federal Government |
recurrent breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer |
Skin Diseases Breast Neoplasms Breast Diseases Recurrence |
Neoplasms Neoplasms by Site |