Clinical trial NCT00231829 (phase 2, status: terminated)
Conditions: uterine cancer
ICD codes: C57.4, D28.2
Drugs: celecoxib
SMILES: COC1=CC=C(C=C1)C(=O)CC(=O)C1=CC=C(C=C1)C(C)(C)C
Reason stopped: 
    due to reported toxicity of celecoxib at high doses
  
Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be at least 18 years of age

          -  Histologically confirmed uterine cancer of the following histologic types: grade 2 or
             grade 3 endometrioid-type, clear cell, or papillary serous types. The pre-therapy
             samples come from either an endometrial sampling (e.g. pipelle) or dilation and
             curettage of the uterus with or without hysteroscopy. Unstained slides of the primary
             tumor, a primary tumor block, or cytologic preparation must be available for review.
             COX-II expression is seen in the majority of patients with these tumor types. Effects
             of COX-II inhibitors occur even in the absence of COX-II expression and will be
             measured with other IHC staining, apoptosis studies and gene expression. Therefore,
             patients will not be tested for COX-II expression preoperatively in order to include
             them in the study.

          -  Disease status: Only patients with clinical stage I or stage II disease will be
             eligible.

          -  Negative urine pregnancy test in women of child-bearing potential (within 14 days of
             the initiation of Celebrex).

          -  All eligible patients need to have a Zubrod/ECOG/GOG performance status ≤2 that
             permits surgery, with or without staging, as indicated.

          -  All patients must be informed of the investigational nature of this study and must
             sign and give written informed consent in accordance with institutional and federal
             guidelines.

        Exclusion Criteria:

          -  Celecoxib is contraindicated in patients with known hypersensitivity to Celecoxib.
             Celecoxib should not be given to patients who have demonstrated allergic-type
             reactions to sulfonamides. Celecoxib should not be given to patients who have
             experienced asthma, urticaria, or allergic-type reactions after taking aspirin or
             other NSAIDs.

          -  Concurrent therapy: Patients who have had daily usage of any form of NSAID or aspirin
             prior to endometrial biopsy will be excluded from this study.

          -  Selective COX-II inhibitors have some activity on the gastrointestinal mucosa.
             Although Celecoxib is not contraindicated in patients with peptic ulcer disease, these
             patients will be excluded to avoid any untoward gastrointestinal side effects.

          -  There is no information regarding the use of Celecoxib in patients with advanced renal
             disease. Therefore, treatment with Celecoxib is not recommended in these patients.

          -  Patient has impairment of hepatic, renal or hematologic function as defined by the
             following baseline laboratory values performed <= 4 weeks prior to the study:

               -  Serum SGOT and/or SGPT > 2.5 times the institutional upper limit of normal
                  (IULN).

               -  Total serum bilirubin > 1.5 mg/dL.

               -  History of chronic active hepatitis or cirrhosis.

               -  Serum creatinine > 2.0 mg/dL.

               -  Platelets < 100,000/mm3

               -  Absolute neutrophil count (ANC) < 1500/mm3

               -  Hemoglobin < 8.0 g/dL

               -  PT/PTT within normal range

               -  Pregnant or nursing women are excluded. Women of child-bearing potential must
                  agree to use a chemical or barrier contraceptive during the dosing portion of the
                  study.