A Phase 1 Study of Carboplatin and Gemcitabine Chemotherapy and Stereotactic Body Radiosurgery for the Palliative Treatment of Persistent or Recurrent Gynecologic Cancer
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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).
TERTIARY OBJECTIVES:
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.
Interventional
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
Yes
Robert DeBernardo, MD
Principal Investigator
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
United States: Institutional Review Board
CASE8810
NCT01652794
May 2012
Name | Location |
---|---|
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |