Cervical Carcinoma Clinical Trial
Official title:
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 3)
This randomized phase II trial studies how well celecoxib works in treating patients with cervical intraepithelial neoplasia, a precancerous lesion of the cervix which can develop into cervical cancer. Celecoxib may be effective in preventing the development of cervical cancer in patients who have cervical intraepithelial neoplasia.
PRIMARY OBJECTIVES:
I. To determine the efficacy of celecoxib to induce complete remission (or partial regression
to cervical intraepithelial neoplasia (CIN) 1) of CIN 2/3 or CIN 3 as evaluated in the
post-treatment excisional biopsy.
II. To determine the toxicity of celecoxib (400 mg once daily) as assessed by Common
Terminology Criteria for Adverse Events in this patient population of women with CIN 2/3 or
CIN 3.
SECONDARY OBJECTIVES:
I. To assess whether treatment with celecoxib changes the number of quadrants containing
acetowhite lesions as determined through colposcopic examination.
II. To determine the efficacy of celecoxib treatment in changing human papillomavirus (HPV)
viral load in cervical cells.
III. To examine the association of histologic response; HPV viral load; lesion size;
proliferation index (marker of proliferation Ki-67 [Ki67]), apoptosis index (terminal
deoxynucleotidyl transferase (TdT)-mediated dUTP nick end labelin [TUNEL] assay),
angiogenesis (vascular endothelial growth factor [VEGF]), and cyclooxygenase-2 (COX-2) in
tissue; the amount of VEGF and basic fibroblast growth factor (bFGF) in serum before and
after treatment; and the amount of celecoxib present in serum during treatment. Cervical
cytology karyometry will be assessed as a potential marker for regression IV. To determine
the feasibility of digital imaging, web-based review of histopathology in a Gynecologic
Oncology Group (GOG) study.
V. To compare the diagnoses of the web-based review of histopathology with the diagnoses of
GOG's standard procedure.
OUTLINE: 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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05458869 -
Evaluating the Human Papillomavirus Self-Collection Experience in Individuals Who Have Experienced Sexual Trauma
|
||
| Not yet recruiting |
NCT04483557 -
Neo-Adjuvant Chemotherapy and Conservative Surgery in Cervical Cancer to Preserve Fertility
|
Phase 2 | |
| Terminated |
NCT04099277 -
A Study of LY3435151 in Participants With Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT04452526 -
I Vaccinate: Testing Multi-Level Interventions to Improve HPV Vaccination
|
N/A | |
| Active, not recruiting |
NCT04443296 -
Study of Tumor Infiltrating Lymphocytes Following CCRT in the Treatment of Patients With Cervical Carcinoma
|
Phase 1 | |
| Recruiting |
NCT05180851 -
Safety and Efficacy of Recombinant Oncolytic Adenovirus L-IFN Injection in Relapsed/Refractory Solid Tumors Clinical Study
|
Early Phase 1 | |
| Withdrawn |
NCT03220009 -
Nivolumab or Expectant Observation Following Ipilimumab, Nivolumab, and Surgery in Treating Patients With High Risk Localized, Locoregionally Advanced, or Recurrent Mucosal Melanoma
|
Phase 2 | |
| Completed |
NCT02460237 -
HPV Self-Test Intervention in Ohio Appalachia
|
N/A | |
| Terminated |
NCT00924066 -
Ixabepilone to Treat Cervical Cancer
|
Phase 2 | |
| Completed |
NCT04208724 -
Support Program for Adoption of Cancer Screening Interventions at a Rural Community-Based Organization
|
N/A | |
| Completed |
NCT03307044 -
Fractional CO2 Laser Therapy for Survivors of Breast Malignancies
|
N/A | |
| Recruiting |
NCT05139368 -
Hypofractionated Radiotherapy for the Treatment of Cervical or Endometrial Cancer
|
N/A | |
| Completed |
NCT03180294 -
Bupropion Hydrochloride in Improving Sexual Desire in Women With Breast or Gynecologic Cancer
|
Phase 2 | |
| Recruiting |
NCT05366478 -
A Clinical Study of LM103 Injection in the Treatment of Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT03849469 -
A Study of XmAb®22841 Monotherapy & in Combination w/ Pembrolizumab in Subjects w/ Selected Advanced Solid Tumors
|
Phase 1 | |
| Terminated |
NCT03345784 -
Testing AZD1775 inC Combination With Radiotherapy and Chemotherapy in Cervical, Upper Vaginal and Uterine Cancers
|
Phase 1 | |
| Completed |
NCT02523365 -
HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA） for Cervical Carcinoma
|
Phase 1/Phase 2 | |
| Completed |
NCT03372720 -
Fractional CO2 Laser Therapy in Minimizing Genitourinary Syndrome of Menopause in Gynecological Cancer Survivors
|
N/A | |
| Active, not recruiting |
NCT03752398 -
A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3)
|
Phase 1 | |
| Active, not recruiting |
NCT00867464 -
Extended Follow Up of Young Women in Costa Rica Who Received Vaccine for Human Papillomavirus Types 16 and 18 and Unvaccinated Controls
|