Carboplatin, Gemcitabine Hydrochloride, and Stereotactic Body Radiation Therapy in Gynecological Cancer
The purpose of this phase I study is to determine the highest dose of carboplatin and gemcitabine (gemcitabine hydrochloride) that can be given safely to subjects with gynecologic cancer, in combination with stereotactic body radiation therapy (SBRT). This dose is called the maximum tolerated dose (MTD). To determine the MTD, patients will receive different amounts of carboplatin and gemcitabine.
Leydig Cell Tumor
Ovarian Stromal Cancer
Recurrent Cervical Cancer
Recurrent Endometrial Carcinoma
Recurrent Fallopian Tube Cancer
Recurrent Ovarian Epithelial Cancer
Recurrent Ovarian Germ Cell Tumor
Recurrent Primary Peritoneal Cavity Cancer
Recurrent Uterine Sarcoma
Recurrent Vaginal Cancer
Recurrent Vulvar Cancer
Radiation: stereotactic body radiation therapy
Drug: gemcitabine hydrochloride
Other: laboratory biomarker analysis
Other: pharmacogenomic studies
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1 Study of Carboplatin and Gemcitabine Chemotherapy and Stereotactic Body Radiosurgery for the Palliative Treatment of Persistent or Recurrent Gynecologic Cancer|
- Rate of acute grade 3-5 toxicities following carboplatin/gemcitabine hydrochloride and SBRT treatment graded based on CTCAE, version 4.0 [ Time Frame: Within 30 days of completing treatment ] [ Designated as safety issue: Yes ]A modified Fibonacci design used during the dose-finding portion of this study. When =< 1 out of 6 patients enter at highest next dose level below the maximum tolerated dose (MTD), this is the recommended phase 2 dose. At least 6 patients must be entered at the recommended phase 2 dose.
- Progression‐free survival [ Time Frame: From the time from registration until time of progression, recurrence, or death, up to 6 months ] [ Designated as safety issue: No ]Calculated following the method of Kaplan and Meier and survival dependence on measured covariates will be assessed using the Cox proportional hazards model.
- Survival dependence on measured covariates [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]Descriptive and tabular data will be reported. Assessed using the Cox proportional hazards model.
|Study Start Date:||May 2012|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Experimental: Treatment (carboplatin, gemcitabine hydrochloride, and SBRT)
Patients also receive carboplatin IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on day 1 and undergo SBRT on days 2-4.
Radiation: stereotactic body radiation therapy
Other Names:Drug: carboplatin
Other Names:Drug: gemcitabine hydrochloride
Other Names:Other: laboratory biomarker analysis
Optional correlative studiesOther: pharmacogenomic studies
Optional correlative studies
Other Name: Pharmacogenomic Study
I. Determine maximum tolerated carboplatin/gemcitabine dose administered with SBRT as measured by < 30‐day acute toxicity defined by Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
I. Off-study SBRT target local control assessment: 6-week post-trial fludeoxyglucose F 18 (18F-FDG) positron emission tomography (PET)/computed tomography (CT) or other imaging response by European Organisation for Research and Treatment of Cancer (EORTC) PET criteria as listed and National Cancer Institute (NCI) guidelines.
II. Off-treatment late toxicity assessment: record 3-month and 6-month radiation-related toxicity defined by CTCAE v4.0.
III. Off‐study global clinical benefit assessment: 6‐month post-therapy clinical benefit (defined as percentage of patients who had complete, partial, or stable disease for at least 6 months).
I. Associate pretherapy tumor biopsy ribonucleotide reductase (R1, R2, p53R2), Tip60 and Poly(ADP‐ribose) polymerase 1/2 expression with 6‐week therapy response.
OUTLINE: This is a dose-escalation study of carboplatin and gemcitabine hydrochloride.
Patients also receive carboplatin intravenously (IV) over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on day 1 and undergo SBRT on days 2-4.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 1 year, and then yearly for 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01652794
|United States, Ohio|
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Steven Waggoner, MD||Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|