Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT00023660
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed squamous, adenocarcinoma, or adenosquamous carcinoma of the cervix
* Stage IIB-IVA OR
* Stage IB-IIA with pelvic node metastases and/or tumor size at least 5 cm
* No small cell, carcinoid, glassy cell, clear cell, or adenoid cystic disease
* No metastatic disease outside of pelvis
* No para-aortic disease
PATIENT CHARACTERISTICS:
Age:
* 18 to 85
Performance status:
* Zubrod 0-2
Life expectancy:
* At least 6 months
Hematopoietic:
* WBC at least 3,000/mm\^3
* Absolute granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
* AST or ALT no greater than 2.5 times upper limit of normal (ULN)
Renal:
* Creatinine no greater than 1.5 mg/dL
* Creatinine clearance at least 50 mL/min
* Calcium no greater than 1.3 times ULN
Cardiovascular:
* No severe heart disease
Other:
* Not pregnant or nursing
* Negative pregnancy test
* HIV negative
* No prior allergy to sulfonamides or non-steroidal anti-inflammatory drugs (NSAIDs)
* No prior hypersensitivity to celecoxib or any component of its formulation
* No medical or psychiatric illness that would preclude study
* No active gastrointestinal (GI) ulcer, GI bleeding, or inflammatory bowel disease
* No other prior malignancy within the past 5 years except cutaneous basal cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No recent prior celecoxib or other cyclo-oxygenase-2 inhibitor
Chemotherapy:
* No prior systemic chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy to pelvis except transvaginal radiotherapy to control bleeding
Surgery:
* No prior surgery for cervical cancer except biopsy
Other:
* No concurrent phenytoin or lithium
* No other concurrent NSAIDs
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT00023660
Study Brief:
Protocol Section:
NCT00023660