Status:
TERMINATED
Biomarkers in Women Receiving Chemotherapy & Celecoxib for Stage II or Stage III Breast Cancer Removable by Surgery
Lead Sponsor:
University of Nebraska
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
19-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer....
Detailed Description
OBJECTIVES: * To determine the safety and efficacy of four courses of neoadjuvant chemotherapy comprising docetaxel, capecitabine, and celecoxib followed by doxorubicin hydrochloride, cyclophosphamid...
Eligibility Criteria
Inclusion
- Pathologic evidence of invasive breast cancer
- Stage II-III disease
- Resectable disease
- Must have a primary tumor estimated by mammogram, ultrasound or palpation to be ≥ 3 cm and/or palpable axillary nodes \> 1 cm for whom neoadjuvant chemotherapy is appropriate
- ECOG performance status 0-1
- Absolute granulocyte count \> 2,000/mm\^3
- Platelet count \> 100,000/mm\^3
- Serum bilirubin \< 1.5 times upper limit of normal (ULN)
- Serum creatinine \< 1.5 times ULN
- Fertile patients must use effective contraception during and for 3 months after completion of study therapy
- At least 2 weeks since prior treatment with cyclooxygenase (COX)-2 inhibitors
Exclusion
- Not pregnant or nursing/negative pregnancy test
- No allergies to sulfa medication, aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs)
- No uncontrolled concurrent illness that might jeopardize the patient's ability to receive the chemotherapy program outlined in this protocol, including any of the following:
- Active infection requiring intravenous antibiotics
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Serious, uncontrolled cardiac arrhythmia
- No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, noninvasive carcinomas, or other cancers from which the patient has been disease-free for at least 5 years
- No prior chemotherapy or radiation therapy for ipsilateral breast cancer
- No concurrent sorivudine or brivudine to treat herpes simplex or herpes zoster viral infections
- No concurrent participation in another therapeutic clinical trial
Key Trial Info
Start Date :
April 15 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2009
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00665457
Start Date
April 15 2004
End Date
July 31 2009
Last Update
September 13 2023
Active Locations (1)
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1
Unversity of Nebraska Medical Center
Omaha, Nebraska, United States, 68198