Clinical trial NCT00045591 (phase 2, status: terminated)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: celecoxib, celecoxib
SMILES: COC1=CC=C(C=C1)C(=O)CC(=O)C1=CC=C(C=C1)C(C)(C)C, COC1=CC=C(C=C1)C(=O)CC(=O)C1=CC=C(C=C1)C(C)(C)C
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed invasive breast cancer

               -  Metastatic or recurrent disease documented by physical or radiographic
                  examination

               -  Isolated recurrence of breast cancer not considered eligible

               -  Bone disease alone allowed

          -  At least 4 prior courses (or 4 months) of chemotherapy resulting in stable disease,
             partial response, or complete response

          -  Treated brain metastases allowed provided all of the following conditions are met:

               -  Palliation achieved without evidence of progression for at least 3 months after
                  completion of radiotherapy and/or surgical treatment

               -  At least 30 days since prior dexamethasone or other corticosteroids

               -  Documentation of another site of metastatic disease (in addition to brain
                  metastases)

          -  Measurable or evaluable disease

          -  Pleural or peritoneal effusion as only manifestation of disease allowed if palliated
             by prior chemotherapy

          -  Hormone receptor status:

               -  Not specified

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Sex

          -  Female

        Menopausal status

          -  Not specified

        Performance status

          -  CTC (ECOG) 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  WBC at least 3,000/mm^3

          -  Absolute neutrophil count at least 1,000/mm^3

          -  Platelet count at least 100,000/mm^3

        Hepatic

          -  Bilirubin no greater than 1.5 times upper limit of normal (ULN)

          -  AST or ALT no greater than 2.5 times ULN (5 times ULN if liver metastases present)

          -  Albumin at least 3.0 g/dL

        Renal

          -  Creatinine no greater than 1.5 times ULN

        Other

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No other active malignancy within the past 2 years except nonmelanoma skin cancer

          -  No active peptic ulcer disease

          -  No known hypersensitivity to sulfonamides, aspirin, or other NSAIDs, including
             celecoxib

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Concurrent trastuzumab (Herceptin) allowed if initiated at least 3 months prior to
             study entry

        Chemotherapy

          -  See Disease Characteristics

          -  At least 6 weeks since prior chemotherapy

          -  No more than 2 prior chemotherapy regimens for recurrent or metastatic disease

        Endocrine therapy

          -  See Disease Characteristics

          -  Prior hormonal therapy for metastatic disease allowed

          -  No concurrent hormonal therapy except hormones for noncancer-related conditions (e.g.,
             insulin for diabetes)

        Radiotherapy

          -  See Disease Characteristics

          -  At least 4 weeks since prior radiotherapy

          -  Prior radiotherapy to the breast and for metastatic disease allowed

          -  No concurrent palliative radiotherapy

        Surgery

          -  See Disease Characteristics

        Other

          -  Prior adjuvant therapy for metastatic disease allowed

          -  Concurrent bisphosphonates allowed

          -  Concurrent low-dose aspirin (no greater than 325 mg/day) is allowed

          -  No other concurrent therapy with celecoxib or other nonsteroidal anti-inflammatory
             drugs (NSAIDs) (e.g., rofecoxib, aspirin, choline magnesium trisalicylate, ibuprofen,
             naproxen, etodolac, oxaprozin, diflunisal, nabumetone, or tolmetin)

          -  No concurrent fluconazole