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Sponsored by: |
Medical University of South Carolina |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00499122 |
RATIONALE: Oxidized glutathione (NOV-002) may stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving NOV-002 together with chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well giving oxidized glutathione (NOV-002) together with doxorubicin and cyclophosphamide followed by docetaxel works in treating women with newly diagnosed stage II or stage III breast cancer.
Condition | Intervention | Phase |
Breast Cancer |
Drug: cyclophosphamide Drug: docetaxel Drug: doxorubicin hydrochloride Drug: glutathione disulfide NOV-002 Procedure: conventional surgery |
Phase II |
Genetics Home Reference related topics: | breast cancer |
MedlinePlus related topics: | Breast Cancer Cancer |
ChemIDplus related topics: | Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Docetaxel Glutathione Glutathione disulfide |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of Neoadjuvant Treatment With NOV-002 in Combination With Doxorubicin and Cyclophosphamide Followed by Docetaxel in Patients With Stages IIB-IIIC Breast Cancer |
Estimated Enrollment: | 46 |
Study Start Date: | May 2007 |
Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oxidized glutathione (NOV-002) IV twice on day -1 of course 1 and once on day 1 of courses 2-8. Patients receive NOV-002 subcutaneously once daily on days 2-21 of courses 1-8. Patients also receive chemotherapy comprising doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 of courses 1-4 followed by docetaxel IV on day 1 of courses 5-8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Patients undergo definitive surgery 3-6 weeks after completion of neoadjuvant therapy.
Blood samples are obtained at baseline and periodically during study to measure serum and plasma protein glutathionlylation. Additional blood samples are collected from some patients for immunological correlative studies.
After completion of study therapy, patients are followed at 30 days.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed infiltrating (i.e., invasive) breast cancer
Clinical stage IIB or IIIC (T2-4, N0 or N1, M0) or (any T, N1-3, M0) disease, as defined by 1 of the following criteria:
Clinically palpable disease that is measurable by RECIST AND meets 1 of the following staging criteria:
Primary tumor ≥ 2 cm (T2-4)
Hormone-receptor status:
PATIENT CHARACTERISTICS:
No prior or concurrent clinically significant (i.e., active) cardiac disease, including any of the following:
PRIOR CONCURRENT THERAPY:
No concurrent localized or partial breast radiotherapy
United States, South Carolina | |||||
Hollings Cancer Center at Medical University of South Carolina | Recruiting | ||||
Charleston, South Carolina, United States, 29425 | |||||
Contact: Clinical Trials Office - Hollings Cancer Center at Medical Uni 843-792-9321 |
Medical University of South Carolina |
Study Chair: | Alberto Montero, MD | Medical University of South Carolina |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000554833, MUSC-101072, MUSC-HR-17111 |
First Received: | July 10, 2007 |
Last Updated: | October 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00499122 |
Health Authority: | Unspecified |
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