Cervical CancerPhase 2NCT00610740
CerviPrep for Applying Topical Gemcitabine to the Cervix in Treating Patients With Primary Endometrial, Cervical, or Ovarian Epithelial Cancer
A Phase 2 study testing topical gemcitabine hydrochloride and therapeutic conventional surgery in people with Cervical Cancer and Endometrial Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Endometrial Cancer, Ovarian Cancer
- What is being tested?
- topical gemcitabine hydrochloride and therapeutic conventional surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Apr 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
About this study
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
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.
Read the 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.
- Conditions
- Cervical Cancer, Endometrial Cancer, Ovarian Cancer
- Being tested
- topical gemcitabine hydrochloride, therapeutic conventional surgery
- Keywords
- recurrent cervical cancer, cervical cancer, endometrial carcinoma, ovarian epithelial cancer, recurrent ovarian epithelial cancer, recurrent endometrial carcinoma
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical gemcitabine hydrochlorideDrug
Also called Gemzar
Gemcitabine 100 mg/m2 will be administered as a single dose, directly to the cervix via the CerviPrep™ device.
therapeutic conventional surgeryProcedure or surgery
Also called removal of uterus
hysterectomy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: topical gemcitabine hydrochloride; Procedure: therapeutic conventional surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 30 minutes post administration
Secondary outcomes (1)
Number of Patients With Measurable Peripheral Vein Concentration of dFdC
Efficacy of the CerviPrep™ device in delivering topical gemcitabine hydrochloride to the cervix as measured by peripheral gemcitabine hydrochloride concentration levels in blood
Measured: 30, 60, 90 minutes post uterine vein sample
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2008 (estimated)
- Study startJul 2006
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Levi S. Downs, MD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00610740
- Sponsor's protocol ID
- 2005LS071
- Other IDs
- WCC #44, UMN-0510M6486
- Status last verified
- Dec 2017
- First submitted
- 7 Feb 2008
- Last updated
- 28 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00610740
- Acronym / sponsor ID
- 2005LS071
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 8 Feb 2008 (estimated)
- Results
- Posted 17 Jun 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Treated with CerviPrep™ | Experimental | Drug: topical gemcitabine hydrochloride, Procedure: therapeutic conventional surgeryCerviPrep™, 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| topical gemcitabine hydrochlorideAlso: GemzarGemcitabine 100 mg/m2 will be administered as a single dose, directly to the cervix via the CerviPrep™ device. | Drug | Patients Treated with CerviPrep™ |
| therapeutic conventional surgeryAlso: removal of uterushysterectomy | Procedure or surgery | Patients Treated with CerviPrep™ |
Primary outcome
Number of Patients With Measurable Concentration of Gemcitabine in Uterine Vein (dFdC)
Time frame: 30 Minutes After Application of Gemcitabine
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
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
1 secondary outcome
Number of Patients With Measurable Peripheral Vein Concentration of dFdC
Time frame: 30, 60, 90 minutes post uterine vein sample
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Levi S. Downs, MD principal investigator
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing topical gemcitabine hydrochloride and therapeutic conventional surgery in people with Cervical Cancer and Endometrial Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Measurable Concentration of Gemcitabine in Uterine Vein (dFdC) (time frame: 30 Minutes After Application of Gemcitabine). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2017.