Cervical Cancer, Endometrial Cancer, Ovarian Cancer
Conditions
Keywords
recurrent cervical cancer, cervical cancer, endometrial carcinoma, ovarian epithelial cancer, recurrent ovarian epithelial cancer, recurrent endometrial carcinoma
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.
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.
Interventions
DRUGtopical gemcitabine hydrochloride
Gemcitabine 100 mg/m2 will be administered as a single dose, directly to the cervix via the CerviPrep™ device.
PROCEDUREtherapeutic conventional surgery
hysterectomy
Sponsors
Masonic Cancer Center, University of Minnesota
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Measurable Concentration of Gemcitabine in Uterine Vein (dFdC) | 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) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Measurable Peripheral Vein Concentration of dFdC | 30, 60, 90 minutes post uterine vein sample | Efficacy of the CerviPrep™ device in delivering topical gemcitabine hydrochloride to the cervix as measured by peripheral gemcitabine hydrochloride concentration levels in blood |
Countries
United States
Participant flow
Recruitment details
5 additional patients were consented, but never treated.
Participants by arm
| Arm | Count |
|---|---|
| Patients Treated With CerviPrep™ During routine hysterectomy for endometrial or cervical carcinoma apply topical gemcitabine 100mg/m\^2 using CerviPrep™ drug delivery system. 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. | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | Patients Treated With CerviPrep™ |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Age, Continuous | 50.4 Years STANDARD_DEVIATION 11.1 |
| Region of Enrollment United States | 18 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 18 |
| serious Total, serious adverse events | 1 / 18 |
Outcome results
Primary
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.
Time frame: 30 Minutes After Application of Gemcitabine
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Patients Treated With CerviPrep™ | Number of Patients With Measurable Concentration of Gemcitabine in Uterine Vein (dFdC) | 5 Participants | 8.2 |
Primary
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
Time frame: 30 minutes post administration
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Patients Treated With CerviPrep™ | Number of Patients With Measurable Concentration of Gemcitabine Metabolites in Uterine Vein (dFdU) | 3 Participants | 80.7 |
Secondary
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
Time frame: 30, 60, 90 minutes post uterine vein sample
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients Treated With CerviPrep™ | Number of Patients With Measurable Peripheral Vein Concentration of dFdC | 30 Minutes | 0 Participants |
| Patients Treated With CerviPrep™ | Number of Patients With Measurable Peripheral Vein Concentration of dFdC | 60 Minutes | 0 Participants |
| Patients Treated With CerviPrep™ | Number of Patients With Measurable Peripheral Vein Concentration of dFdC | 90 Minutes | 0 Participants |