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WCC# 44: A Pilot Study of CerviPrep, a Novel Drug Delivery Device for the Cervix, in the Local Administration of Gemcitabine, a Radiation Sensitizer


Phase 2
18 Years
N/A
Not Enrolling
Female
Cervical Cancer, Endometrial Cancer, Ovarian Cancer

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Trial Information

WCC# 44: A Pilot Study of CerviPrep, a Novel Drug Delivery Device for the Cervix, in the Local Administration of Gemcitabine, a Radiation Sensitizer


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Patients With Measurable Concentration of Gemcitabine in Uterine Vein (dFdC)

Outcome Description:

Efficacy of the CerviPrep™ device in delivering topical gemcitabine hydrochloride to the cervix as measured by gemcitabine hydrochloride concentration levels in tissue samples.

Outcome Time Frame:

30 Minutes After Application of Gemcitabine

Safety Issue:

No

Principal Investigator

Levi S. Downs, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota

Authority:

United States: Food and Drug Administration

Study ID:

2005LS071

NCT ID:

NCT00610740

Start Date:

July 2006

Completion Date:

April 2008

Related Keywords:

  • Cervical Cancer
  • Endometrial Cancer
  • Ovarian Cancer
  • recurrent cervical cancer
  • cervical cancer
  • endometrial carcinoma
  • ovarian epithelial cancer
  • recurrent ovarian epithelial cancer
  • recurrent endometrial carcinoma
  • Endometrial Neoplasms
  • Uterine Cervical Neoplasms
  • Ovarian Neoplasms
  • Adenoma
  • Neoplasms, Glandular and Epithelial

Name

Location

University of Minnesota Cancer CenterMinneapolis, Minnesota  55455