Status:
TERMINATED
A Pilot Study of Celecoxib in Patients With Grade 2 or 3 Uterine Cancers
Lead Sponsor:
Mark H. Einstein
Collaborating Sponsors:
Pharmacia
Conditions:
Uterine Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Expression of COX-II has been identified in many types of human cancers. Uterine cancer is the most common gynecologic cancer in the US and there has been an increase in uterine cancer deaths over the...
Detailed Description
Endometrial cancer is the most common gynecologic cancer in the United States. The number of deaths from endometrial cancer has risen 128% since 1987. In 2001, an estimated 38,300 women will develop e...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
End Date :
March 1 2004
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00231829
Start Date
April 1 2003
End Date
March 1 2004
Last Update
April 24 2012
Active Locations (1)
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1
Montefiore Medical Center
The Bronx, New York, United States, 10461