Oxidized Glutathione (NOV-002), Doxorubicin, Cyclophosphamide, and Docetaxel in Treating Women With Newly Diagnosed Stage IIB, or Stage IIIC Breast Cancer
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.
Drug: Doxorubicin hydrochloride
Drug: Glutathione disulfide NOV-002
Procedure: conventional surgery
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Percentage of Participants Achieving Pathologic Complete Response [ Time Frame: 4 years ] [ Designated as safety issue: No ]Pathologic complete response (pCR) is defined according to Hankoop et al  as either: the absence of any histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast or the presence of invasive tumor equal to or less than 10mm after preoperative treatment, determined at definitive breast surgery.
- To Define the Safety Profiles of Preoperative Administration of NOV-002 in Combination With Doxorubicin, Cyclophosphamide Followed by Docetaxel. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
- To Correlate Serum Protein Glutathionylation With Clinical and Pathologic Responses [ Time Frame: 4 years ] [ Designated as safety issue: No ]
|Study Start Date:||May 2007|
|Study Completion Date:||April 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
|Experimental: NOV-002 and Doxorubicin, Cyclophosphamide and Docetaxel||Drug: Cyclophosphamide Drug: Docetaxel Drug: Doxorubicin hydrochloride Drug: Glutathione disulfide NOV-002 Procedure: conventional surgery|
- The primary objective of this study is to define the rate of pathologic complete response rate (pCR) in the affected breast after the preoperative administration of NOV-002 in combination with doxorubicin and cyclophosphamide followed by docetaxel in patients with stage IIB-IIIC breast cancer.
- Define the safety profiles of preoperative administration of NOV-002 in combination with doxorubicin hydrochloride and cyclophosphamide followed by docetaxel.
- Correlate serum protein glutathionylation with clinical and pathologic responses.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00499122
|United States, Florida|
|University of Miami Sylvester Comprehensive Cancer Center - Miami|
|Miami, Florida, United States, 33136|
|United States, South Carolina|
|Hollings Cancer Center at Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Study Chair:||Keisuke Shirai, MD||Medical University of South Carolina|
|Principal Investigator:||Alberto Montero, MD||University of Miami Sylvester Comprehensive Cancer Center|