Status:
TERMINATED
Nexium Study To Suppress Nausea During Chemotherapy
Lead Sponsor:
Baylor Breast Care Center
Collaborating Sponsors:
AstraZeneca
Conditions:
Nausea
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
This study will look at a drug called esomeprazole, the newest PPI, as a way to further reduce the amount of nausea and vomiting seen in breast cancer patients receiving adriamycin or epirubicin chemo...
Detailed Description
1. Breast Cancer The American Cancer Society estimates that there will be approximately 215,990 new cases of breast cancer diagnosed in women during 2004 in the United States. Breast cancer is the...
Eligibility Criteria
Inclusion
- For inclusion, participants must:
- be female, age 18 years or older
- sign an informed consent
- have Stage I, II, or III breast cancer
- be receiving at least four cycles of anthracycline-based chemotherapy which may include: doxorubicin/cyclophosphamide AC),5-fluorouracil/doxorubicin/cyclophosphamide (FAC), fluoruracil/epirubicin/cyclophosphamide (FEC) or dose dense chemotherapy regimen (AC every two weeks) as their agents for neoadjuvant or adjuvant chemotherapy
- patient must receive a serotonin receptor antagonist and a steroid for premedication
- have a negative serum pregnancy test within 7 days prior to starting study if pre-menopausal
- have adequate renal function, defined by a serum creatinine within 1.5 times the upper limit of normal
- have adequate liver function, defined by a total bilirubin, SGOT, alkaline phosphatase and albumin within 1.5 times the upper limits of normal
- have adequate bone marrow function, defined as a WBC \>4.0, platelet count \>100K, and HCT \>30
- have no prior or current malignancies for which chemotherapy was utilized
- have a performance status of at least 2 according to the Eastern Cooperative Oncology Group World Health Organization or a Karnofsky score of 50% or greater.
Exclusion
- pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential
- severe or underlying chronic illness or disease
- renal insufficiency or liver abnormalities
- chronic use of steroids
- uncontrolled GERD
- current use of proton pump inhibitors
- history of Barrett's esophagus
- history of erosive gastritis
- intolerance to serotonin receptor antagonists
- current use of aprepitant or palonosetron as antiemetics
- concomitant use of H2-receptor antagonists (ranitidine, cimetidine, famotidine or nizatidine) or metaclopramide
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00206440
Start Date
August 1 2005
End Date
February 1 2012
Last Update
December 6 2018
Active Locations (1)
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1
Baylor Breast Center
Houston, Texas, United States, 77030