CerviPrep for Applying Topical Gemcitabine to the Cervix in Treating Patients With Primary Endometrial, Cervical, or Ovarian Epithelial Cancer
NCT ID: NCT00610740
Last Updated: 2017-12-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
18 participants
INTERVENTIONAL
2006-07-31
2008-04-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Patients Treated with CerviPrep™
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.
topical gemcitabine hydrochloride
Gemcitabine 100 mg/m2 will be administered as a single dose, directly to the cervix via the CerviPrep™ device.
therapeutic conventional surgery
hysterectomy
Interventions
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topical gemcitabine hydrochloride
Gemcitabine 100 mg/m2 will be administered as a single dose, directly to the cervix via the CerviPrep™ device.
therapeutic conventional surgery
hysterectomy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Masonic Cancer Center, University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Levi S. Downs, MD
Role: PRINCIPAL_INVESTIGATOR
Masonic Cancer Center, University of Minnesota
Locations
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University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Countries
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Other Identifiers
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WCC #44
Identifier Type: OTHER
Identifier Source: secondary_id
UMN-0510M6486
Identifier Type: OTHER
Identifier Source: secondary_id
2005LS071
Identifier Type: -
Identifier Source: org_study_id