This is a phase II study of rucaparib, a small molecule inhibitor poly (adenosine diphosphate \[ADP\]-ribose) polymerase (PARP), being tested in combination with bevacizumab in patients with recurrent cervical or endometrial cancer. The objective of this study is to determine the proportion of these patients who survive progression-free for at least 6 months while receiving this drug combination.
Patients who consent to participate in this study will receive treatment with rucaparib and bevacizumab until unacceptable toxicity or tumor progression. Subjects will take one rucaparib pill will be taken twice daily, and bevacizumab will be adimistered via IV onDay 1 of each 21 day cycle. Subjects will receive tests and procedures that are part of regular cancer care as well as those required for the purposes of this study. If there is no cancer found in scans after 6 cycles of treatment, patients may continue with study treatment for 1 year. Follow up visits will occur every 3 months for the first 2 years after treatment is completed and every 6 months for 3 additional years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Rucaparib 600mg PO BID daily
Bevacizumab 15mg/kg IV on day 1 of each cycle
University of Minnesota
Minneapolis, Minnesota, United States
Stephenson Cancer Center, University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
University of Virginia Cancer Center
Charlottesville, Virginia, United States
Proportion of Patients Who Are Progression-free at 6 Months
To estimate the proportion of pts treated w/bevacizumab who are progression-free. Progression for measurable disease per RECIST v1.1. Progression for pts with non-measurable disease at baseline is defined as increasing clinical, radiological, or histological evidence of disease since study entry.
Time frame: 6 months
Proportion of Patients Who Had Objective Tumor Response
To estimate the proportion of patients treated with bevacizumab and rucaparib who have objective tumor response (complete or partial)
Time frame: up to 2 years
Number of Patients Who Experience Toxicity
To determine the nature and degree of toxicity in combination of rucaparib and bevacizumab (Adverse Event Grade 3 and higher).
Time frame: up to 2 year
Median Overall Survival
To estimate the median overall survival of patients treated with combination rucaparib and bevacizumab.
Time frame: up to 2 years
Median Progression-free Survival Time
To estimate the progression-free survival (PFS) of patients with persistent or recurrent cervical or endometrial cancer treated with combination rucaparib and bevacizumab Progression for measurable disease per RECIST v1.1 Progression for patients with non-measurable disease at baseline is defined as increasing clinical, radiological, or histological evidence of disease since study entry.
Time frame: up to 2 years
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