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

University of Minnesota (UMN)

Status and phase: Completed; Phase 2

Conditions: Endometrial Cancer; Ovarian Cancer; Cervical Cancer

Treatments: Drug: topical gemcitabine hydrochloride; Procedure: therapeutic conventional surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT00610740

2005LS071

WCC #44 (Other Identifier)

UMN-0510M6486 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Patients Treated with CerviPrep™

Experimental group

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.

Treatment:

Procedure: therapeutic conventional surgery

Drug: topical gemcitabine hydrochloride