A Phase I/II Study Of COX-2 Inhibitor, CELEBREX (CELECOXIB), And Chemoradiation In Patients With Locally Advanced Cervical Cancer

Inclusion 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