Phase 2 N=18 Treatment

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

Cervical Cancer · Endometrial Cancer · Ovarian Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00610740 ↗

Enrolled (actual)

Serious AEs

5.6%

Results posted

Jun 2010

Primary outcome: Primary: Number of Patients With Measurable Concentration of Gemcitabine in Uterine Vein (dFdC) — 5 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: topical gemcitabine hydrochloride (Drug); therapeutic conventional surgery (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Masonic Cancer Center, University of Minnesota
Primary completion: Apr 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients With Measurable Concentration of Gemcitabine in Uterine Vein (dFdC)	5	—
PRIMARY Number of Patients With Measurable Concentration of Gemcitabine Metabolites in Uterine Vein (dFdU)	3	—
SECONDARY Number of Patients With Measurable Peripheral Vein Concentration of dFdC	0; 0; 0	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00610740). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.