Ovarian Cancer Clinical Trial
CerviPrep for Applying Topical Gemcitabine to the Cervix in Treating Patients With Primary Endometrial, Cervical, or Ovarian Epithelial Cancer
Summary
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 CerviPrepâ„¢ 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 CerviPrepâ„¢ works in applying topical gemcitabine to the cervix in treating patients with primary endometrial cancer, cervical cancer, or ovarian epithelial cancer.
Full Description
OBJECTIVES:
Primary
To evaluate the efficacy of the CerviPrepâ„¢ 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 CerviPrepâ„¢ 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.
Eligibility Criteria
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
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There is 1 Location for this study
Minneapolis Minnesota, 55455, United States
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