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

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Masonic Cancer Center, University of Minnesota
• Treatments: Gemcitabine

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