Carboplatin, Gemcitabine Hydrochloride, and Stereotactic Body Radiation Therapy in Gynecological Cancer
|ClinicalTrials.gov Identifier: NCT01652794|
Recruitment Status : Completed
First Posted : July 30, 2012
Last Update Posted : August 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Leydig Cell Tumor Ovarian Sarcoma Ovarian Stromal Cancer Pseudomyxoma Peritonei 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: carboplatin Drug: gemcitabine hydrochloride Other: laboratory biomarker analysis Other: pharmacogenomic studies||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||March 2015|
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
Drug: gemcitabine hydrochloride
Other: laboratory biomarker analysis
Optional correlative studies
Other: pharmacogenomic studies
Optional correlative studies
Other Name: Pharmacogenomic Study
- 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 ]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 ]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 ]Descriptive and tabular data will be reported. Assessed using the Cox proportional hazards model.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|