A Phase 1 Study of Carboplatin and Gemcitabine Chemotherapy and Stereotactic Body Radiosurgery for the Palliative Treatment of Persistent or Recurrent Gynecologic Cancer
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
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.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of acute grade 3-5 toxicities following carboplatin/gemcitabine hydrochloride and SBRT treatment graded based on CTCAE, version 4.0
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.
Within 30 days of completing treatment
Robert DeBernardo, MD
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
United States: Institutional Review Board
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|