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A Randomized Double-Blind Phase II Trial of Celecoxib, a COX-2 Inhibitor, in the Treatment of Patients With Cervical Intraepithelial Neoplasia 2/3 or 3 (CIN 2/3 or CIN 3)


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Cervical Cancer, Precancerous Condition

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Trial Information

A Randomized Double-Blind Phase II Trial of Celecoxib, a COX-2 Inhibitor, in the Treatment of Patients With Cervical Intraepithelial Neoplasia 2/3 or 3 (CIN 2/3 or CIN 3)


OBJECTIVES:

Primary

- Determine the efficacy of celecoxib, in terms of achieving histologic complete or
partial response, in patients with cervical intraepithelial neoplasia (CIN) 2/3 or 3.

- Determine the toxicity of this drug in these patients.

Secondary

- Determine the effect of this drug on changes in lesion size in these patients.

- Determine the effect of this drug on human papillomavirus (HPV) viral load in these
patients.

- Correlate histologic response, HPV viral load, lesion size, proliferation index,
apoptosis index, angiogenesis (VEGF) and COX-2 in tissue, amount of VEGF and bFGF in
serum, and serum celecoxib levels during treatment in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to lesion size (covering ≤ ½ area of the cervix vs covering > ½
area of the cervix) and degree of cervical intraepithelial neoplasia (CIN) (CIN 2/3 vs CIN
3). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral celecoxib once daily for 14-18 weeks.

- Arm II: Patients receive oral placebo once daily for 14-18 weeks. Patients undergo
colposcopy at week 8 and between weeks 14 and 18. Between weeks 14 and 18, patients
with evidence of disease also undergo large loop excision of the transformation zone
(cone biopsy) or cervical biopsy and patients with no evidence of disease undergo a
cervical biopsy to confirm the absence of disease on colposcopy.

PROJECTED ACCRUAL: A maximum of 130 patients (39 per treatment arm) will be accrued for this
study within 13 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed cervical intraepithelial neoplasia (CIN) 2/3 or 3 by
cervical biopsy 2-8 weeks prior to study entry

- Pathology report must clearly state "CIN 2/3" or "3" OR "moderate-severe
dysplasia," "moderate-severe dyskaryosis," "severe dysplasia," or "sever
dyskaryosis."

- No CIN 2 alone OR moderate dysplasia or dyskaryosis alone

- Colposcopically visible cervical lesion at study entry that is consistent with biopsy

- No evidence of endocervical dysplasia or invasive cancer by cytology or biopsy

- No history of cervical cancer

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- GOG 0-2

Life expectancy

- Not specified

Hematopoietic

- Platelet count > 125,000/mm^3

- Hemoglobin > 11.0 g/dL

- WBC > 3,000/mm^3

- No significant bleeding disorder

Hepatic

- Bilirubin ≤ 1.5 times upper limit of normal (ULN) (> 1.5 times ULN allowed if due to
Gilbert's disease)

- AST and ALT < 2.0 times ULN

- No hepatic disorder

Renal

- Creatinine ≤ 1.5 times ULN

- No known renal failure

Cardiovascular

- No history of transient ischemic attack or stroke

- No history of cardiovascular disease

- No uncontrolled hypertension

Other

- No undiagnosed abnormal vaginal bleeding

- No known immunocompromised condition

- No known allergic reaction (such as asthma, urticaria, or other reaction) to NSAIDs
or aspirin

- No known hypersensitivity to celecoxib

- No known allergic reaction to sulfonamides

- No history of peptic ulcer disease

- Must be good candidate for delayed treatment of CIN (i.e., deemed reliable to return
for follow-up and provide adequate contact information)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- No prior renal transplantation

Other

- At least 15 days since prior nonsteriodal anti-inflammatory agents (NSAIDs) or
aspirin

- No other concurrent NSAIDs or aspirin

- No concurrent fluconazole or lithium

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention

Outcome Measure:

Histologic complete response

Safety Issue:

No

Principal Investigator

Janet S. Rader, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Washington University Siteman Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000360805

NCT ID:

NCT00081263

Start Date:

June 2005

Completion Date:

Related Keywords:

  • Cervical Cancer
  • Precancerous Condition
  • cervical cancer
  • cervical intraepithelial neoplasia grade 2
  • cervical intraepithelial neoplasia grade 3
  • Neoplasms
  • Uterine Cervical Neoplasms
  • Precancerous Conditions
  • Cervical Intraepithelial Neoplasia
  • Carcinoma in Situ

Name

Location

CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Elkhart General HospitalElkhart, Indiana  46515
Howard Community HospitalKokomo, Indiana  46904
Lakeland Regional Cancer Care Center - St. JosephSt. Joseph, Michigan  49085
Cancer Care Associates - Saint Francis CampusTulsa, Oklahoma  74136-1929
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
Michiana Hematology-Oncology, PC - ElkhartElkhart, Indiana  46514
Elkhart Clinic, LLCElkhart, Indiana  46514-2098
Michiana Hematology Oncology PC - La PorteLa Porte, Indiana  46350
Michiana Hematology-Oncology, PC - South BendMishawaka, Indiana  46545-1470
Michiana Hematology Oncology PC - PlymouthPlymouth, Indiana  46563
Lakeside Cancer Specialists, PLLCSaint Joseph, Michigan  49085
FirstHealth Moore Regional Community Hospital Comprehensive Cancer CenterPinehurst, North Carolina  28374
Women's Cancer Center - La CanadaLas Vegas, Nevada  89169