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

NCT00610740 | Completed Phase 2 Results DMC

• 3 other identifiers: 2005LS071WCC #44UMN-0510M6486
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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™ 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.

Conditions

Cervical Cancer; Endometrial Cancer; Ovarian Cancer

Keywords

recurrent cervical cancer; cervical cancer; endometrial carcinoma; ovarian epithelial cancer; recurrent ovarian epithelial cancer; recurrent endometrial carcinoma

Outcome Measures

Primary Outcomes (2)

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

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

  30 Minutes After Application of Gemcitabine

• Number of Patients With Measurable Concentration of Gemcitabine Metabolites in Uterine Vein (dFdU)

  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

  30 minutes post administration

Secondary Outcomes (1)

• Number of Patients With Measurable Peripheral Vein Concentration of dFdC

  30, 60, 90 minutes post uterine vein sample

Study Arms (1)

Patients Treated with CerviPrep™

EXPERIMENTAL

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; Procedure: therapeutic conventional surgery

Interventions

topical gemcitabine hydrochloride DRUG

Gemcitabine 100 mg/m2 will be administered as a single dose, directly to the cervix via the CerviPrep™ device.

Also known as: Gemzar

Patients Treated with CerviPrep™

therapeutic conventional surgery PROCEDURE

hysterectomy

Also known as: removal of uterus

Patients Treated with CerviPrep™

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Endometrial Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Gemcitabine; Hysterectomy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Levi Downs, Jr., M.D.
• Organization: Masonic Cancer Center, University of Minnesota

downs008@umn.edu

612-626-6628

Study Officials

• Levi S. Downs, MD

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2008
• First Posted: February 8, 2008
• Study Start: July 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: December 28, 2017
• Results First Posted: June 17, 2010

Record last verified: 2017-12

Locations

US (1)