Status:
COMPLETED
CerviPrep for Applying Topical Gemcitabine to the Cervix in Treating Patients With Primary Endometrial, Cervical, or Ovarian Epithelial Cancer
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Cervical Cancer
Endometrial Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00610740
Start Date
July 1 2006
End Date
April 1 2008
Last Update
December 28 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455