Clinical trial NCT00610740: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cervical Cancer
Endometrial Cancer
Ovarian Cancer
Keywords: recurrent cervical cancer
cervical cancer
endometrial carcinoma
ovarian epithelial cancer
recurrent ovarian epithelial cancer
recurrent endometrial carcinoma
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2008-02-08
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Patients With Measurable Concentration of Gemcitabine in Uterine Vein (dFdC)
timeFrame: 30 Minutes After Application of Gemcitabine
measure: Number of Patients With Measurable Concentration of Gemcitabine Metabolites in Uterine Vein (dFdU)
timeFrame: 30 minutes post administration
Secondary outcomes:
measure: Number of Patients With Measurable Peripheral Vein Concentration of dFdC
timeFrame: 30, 60, 90 minutes post uterine vein sample
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Cancer Center
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Levi S. Downs, MD
role: PRINCIPAL_INVESTIGATOR
References: