Recurrent Ovarian Epithelial Cancer Clinical Trial
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
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.
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.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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