Patient case: 26-year-old female with Cervical cancer. Genetic variant: STK11. Other conditions: None.

Clinical trial: S0212 Celecoxib in Treating Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix

Summary: RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. Celecoxib may be effective in preventing cervical cancer.
  PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing cervical cancer in patients who have high-grade squamous intraepithelial lesions of the cervix.

Detailed description: OBJECTIVES:
  -  Compare the complete response rate in patients with high-grade squamous intraepithelial lesions of the cervix treated with celecoxib vs placebo.
  -  Compare the toxicity of these drugs in these patients.
  -  Determine, preliminarily, the effect of celecoxib on cyclooxygenase-2 expression and human papilloma virus expression in these patients.
  OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to high-grade squamous intraepithelial lesion status (cervical intraepithelial neoplasia [CIN] 2 vs CIN 3). Patients are randomized to 1 of 2 treatment arms.
  -  Arm I: Patients receive oral celecoxib twice daily for 1 month.
  -  Arm II: Patients receive oral placebo twice daily for 1 month. In both arms, treatment repeats monthly for 3 courses in the absence of disease progression or unacceptable toxicity. All patients then undergo loop electrosurgical excision procedure or cone biopsy to determine response.
  PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study within 1-2 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed high-grade squamous intraepithelial lesions (HGSIL) of the cervix
  -  Cervical intraepithelial neoplasia (CIN) 2 (moderate dysplasia) OR CIN 3 (severe dysplasia, carcinoma in situ)
  -  Must have remaining HGSIL after biopsy
  -  No suspicion of invasive cancer by colposcopy within the past 28 days
  -  No invasive or preinvasive high-grade intraepithelial neoplasia by endocervical curettage within the past 56 days
  PATIENT CHARACTERISTICS:
  Age
  -  18 and over
  Performance status
  -  Zubrod 0-1
  Life expectancy
  -  Not specified
  Hematopoietic
  -  Not specified
  Hepatic
  -  SGOT and SGPT less than 2.0 times upper limit of normal (ULN)
  -  Bilirubin less than 2.0 times ULN
  Renal
  -  Creatinine less than 2.0 mg/dL
  Immunologic
  -  No prior asthma, urticaria, or allergic-type reactions to aspirin or other NSAIDs
  -  No allergy to sulfonamides
  -  No known sensitivity to celecoxib
  -  No known AIDS or HIV-associated complex
  Other
  -  Not pregnant or nursing
  -  Fertile patients must use effective contraception
  -  No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated stage I or II cancer currently in complete remission
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  Not specified
  Chemotherapy
  -  Not specified
  Endocrine therapy
  -  Not specified
  Radiotherapy
  -  No prior pelvic radiotherapy
  Surgery
  -  See Disease Characteristics
  Other
  -  More than 3 months since prior topical medications for genital condyloma
  -  No prior treatment for squamous intraepithelial lesions
  -  No concurrent topical medications for genital condyloma
  -  No other concurrent treatment
  -  No concurrent chronic (daily for more than 30 days) aspirin
  -  No other concurrent nonsteroidal anti-inflammatory drugs (NSAIDs)

Relevance to patient case: not relevant