Brief Title
CerviPrep for Applying Topical Gemcitabine to the Cervix in Treating Patients With Primary Endometrial, Cervical, or Ovarian Epithelial Cancer
Official Title
WCC# 44: A Pilot Study of CerviPrep, a Novel Drug Delivery Device for the Cervix, in the Local Administration of Gemcitabine, a Radiation Sensitizer
Brief 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 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.
Detailed Description
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Number of Patients With Measurable Concentration of Gemcitabine in Uterine Vein (dFdC)
Secondary Outcome
Number of Patients With Measurable Peripheral Vein Concentration of dFdC
Condition
Cervical Cancer
Intervention
topical gemcitabine hydrochloride
Study Arms / Comparison Groups
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
18
Start Date
July 2006
Completion Date
April 2008
Primary Completion Date
April 2008
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Levi S. Downs, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00610740
Organization ID
2005LS071
Secondary IDs
WCC #44
Responsible Party
Sponsor
Study Sponsor
Masonic Cancer Center, University of Minnesota
Study Sponsor
Levi S. Downs, MD, Principal Investigator, Masonic Cancer Center, University of Minnesota
Verification Date
December 2017