Clinical trial · Interventional
CerviPrep for Applying Topical Gemcitabine to the Cervix in Treating Patients With Primary Endometrial, Cervical, or Ovarian Epithelial Cancer
WCC# 44: A Pilot Study of CerviPrep, a Novel Drug Delivery Device for the Cervix, in the Local Administration of Gemcitabine, a Radiation Sensitizer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Using the CerviPrep™ drug delivery device to apply topical gemcitabine to the cervix may be an effective way to kill more tumor cells. PURPOSE: This phase II trial is studying how well CerviPrep™ works in applying topical gemcitabine to the cervix in treating patients with primary endometrial cancer, cervical cancer, or ovarian epithelial cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
| topical gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients Treated with CerviPrep™
- description
- CerviPrep™, a novel drug delivery device, was developed specifically for applying pharmaceuticals directly on the cervix. It consists of a syringe-like tube attached to a plastic cap that covers the cervix. Drug can be delivered through the tube, directly to the cervix without spillage onto vaginal or vulvar tissues.
- interventionNames
- Drug: topical gemcitabine hydrochloride
- Procedure: therapeutic conventional surgery
Primary outcomes (2)
- measure
- Number of Patients With Measurable Concentration of Gemcitabine in Uterine Vein (dFdC)
- timeFrame
- 30 Minutes After Application of Gemcitabine
- description
- Efficacy of the CerviPrep™ device in delivering topical gemcitabine hydrochloride to the cervix as measured by gemcitabine hydrochloride concentration levels in tissue samples.
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of primary endometrial or cervical cancer * Scheduled to undergo abdominal hysterectomy as part of surgical staging and/or treatment * Gynecologic Oncology Group (GOG) performance status 0-2 * Absolute neutrophil count (ANC) ≥ 1,500 cells/mm³ * Platelet count ≥ 100,000 cells/mm³ * Creatinine ≤ 2.5 mg/dL * Serum Aspartate aminotransferase (AST) or Alanine transaminase (ALT) ≤ 3 times upper limit of normal * Total bilirubin ≤ 2.0 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception Exclusion Criteria: * Serious medical condition or psychiatric illness that places the patient at an unacceptable risk for study participation or precludes signing the informed consent * Known allergic reaction or hypersensitivity to gemcitabine hydrochloride * Prior radiotherapy to the whole abdomen or pelvis * More than 28 days since prior standard or experimental anticancer therapy * No other concurrent anticancer agents
References
Publications (0)
Data not yet available