CerviPrep for Applying Topical Gemcitabine to the Cervix in Treating Patients With Primary Endometrial, Cervical, or Ovarian Epithelial Cancer

OBJECTIVES:

Primary

• To evaluate the efficacy of the CerviPrep™ device in delivering topical gemcitabine hydrochloride to the cervix

Secondary

• To document any side effects directly attributed to local administration of gemcitabine hydrochloride.

OUTLINE: Patients undergo application of topical gemcitabine hydrochloride directly to the cervix using the CerviPrep™ drug delivery device during routine hysterectomy.

Uterine vein and peripheral blood samples are obtained periodically to measure local and peripheral gemcitabine hydrochloride concentration levels in the blood. Local gemcitabine hydrochloride concentration levels are also measured in uterine tissue samples obtained from the surgical specimen after hysterectomy.

Patients complete a self-reported symptom diary for the first 7 days after surgery for assessment of local and systemic side effects associated with topical administration of gemcitabine hydrochloride.

After completion of study therapy, patients are followed at 2-4 weeks.

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