CerviPrep for Applying Topical Gemcitabine to the Cervix in Treating Patients With Primary Endometrial, Cervical, or Ovarian Epithelial Cancer
This study has been completed.
Sponsor:
Masonic Cancer Center, University of Minnesota
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT00610740
First received: February 7, 2008
Last updated: November 6, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cervical Cancer Endometrial Cancer Ovarian Cancer |
Drug: topical gemcitabine hydrochloride Procedure: therapeutic conventional surgery |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | WCC# 44: A Pilot Study of CerviPrep, a Novel Drug Delivery Device for the Cervix, in the Local Administration of Gemcitabine, a Radiation Sensitizer |
Resource links provided by NLM:
Further study details as provided by Masonic Cancer Center, University of Minnesota:
Primary Outcome Measures:
- Number of Patients With Measurable Concentration of Gemcitabine in Uterine Vein (dFdC) [ Time Frame: 30 Minutes After Application of Gemcitabine ] [ Designated as safety issue: No ]Efficacy of the CerviPrep™ device in delivering topical gemcitabine hydrochloride to the cervix as measured by gemcitabine hydrochloride concentration levels in tissue samples.
- Number of Patients With Measurable Concentration of Gemcitabine Metabolites in Uterine Vein (dFdU) [ Time Frame: 30 minutes post administration ] [ Designated as safety issue: No ]Efficacy of the CerviPrep™ device in delivering topical gemcitabine hydrochloride to the cervix as measured by local (uterine vein) gemcitabine hydrochloride concentration levels in blood
Secondary Outcome Measures:
- Number of Patients With Measurable Peripheral Vein Concentration of dFdC [ Time Frame: 30, 60, 90 minutes post uterine vein sample ] [ Designated as safety issue: No ]Efficacy of the CerviPrep™ device in delivering topical gemcitabine hydrochloride to the cervix as measured by peripheral gemcitabine hydrochloride concentration levels in blood
| Enrollment: | 18 |
| Study Start Date: | July 2006 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Patients Treated with CerviPrep™
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.
|
Drug: topical gemcitabine hydrochloride
Gemcitabine 100 mg/m2 will be administered as a single dose, directly to the cervix via the CerviPrep™ device.
Other Name: Gemzar
Procedure: therapeutic conventional surgery
hysterectomy
Other Name: removal of uterus
|
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 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00610740
Locations
| United States, Minnesota | |
| University of Minnesota Cancer Center | |
| Minneapolis, Minnesota, United States, 55455 | |
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
| Principal Investigator: | Levi S. Downs, MD | Masonic Cancer Center, University of Minnesota |
More Information
Additional Information:
No publications provided
| Responsible Party: | Masonic Cancer Center, University of Minnesota |
| ClinicalTrials.gov Identifier: | NCT00610740 History of Changes |
| Other Study ID Numbers: | 2005LS071, WCC #44, UMN-0510M6486 |
| Study First Received: | February 7, 2008 |
| Results First Received: | May 19, 2010 |
| Last Updated: | November 6, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Masonic Cancer Center, University of Minnesota:
|
recurrent cervical cancer cervical cancer endometrial carcinoma |
ovarian epithelial cancer recurrent ovarian epithelial cancer recurrent endometrial carcinoma |
Additional relevant MeSH terms:
|
Endometrial Neoplasms Uterine Cervical Neoplasms Ovarian Neoplasms Adenoma Neoplasms, Glandular and Epithelial Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Diseases Genital Diseases, Female Uterine Cervical Diseases Endocrine Gland Neoplasms Ovarian Diseases |
Adnexal Diseases Endocrine System Diseases Gonadal Disorders Neoplasms by Histologic Type Radiation-Sensitizing Agents Gemcitabine Physiological Effects of Drugs Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 23, 2013