Investigators hypothesize that concurrent ribociclib treatment and chemotherapy will enhance the response to platinum-based therapy and maintenance therapy will slow ovarian cancer tumor growth leading to prolongation in progression free survival.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Ribociclib (LEE-011) will be given on days 1-4, 8-11, and 15-18 of a 28 day cycle at 200, 400, or 600mg/day during the dose escalation phase. During the maintenance phase, ribociclib (LEE-011) will be given at 600mg/day, 3 weeks on, 1 week off until progression.
During the escalation phase Paclitaxel will be given on days 1, 8, and 15 of a 28 day cycle.
During the escalation phase Carboplatin will be given on days 1, 8, and 15 of a 28 day cycle.
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
UPMC Hillman Cancer Center Upper St. Clair
Bethel Park, Pennsylvania, United States
UPMC Hillman Cancer Center Arnold Palmer at Mountain View
Greensburg, Pennsylvania, United States
Maximal tolerated dose (MTD) of ribociclib (LEE-011) when given with carboplatin + paclitaxel in platinum-sensitive recurrent ovarian cancer
Participants will be observed for the first two treatment cycles (2, 28 day cycles) and maximum tolerated dose will be determined.
Time frame: 56 days
Number of participants that respond to treatment
Overall response rate (ORR) will be analyzed. The number of patients that respond to treatment (exhibit Partial Response (PR) or Complete Response (CR)) will be recorded. PR is defined as at least a 50% reduction in CA 125 levels (response must be confirmed and maintained for at least 28 days) and/or at least 30% decrease in the sum diameters of target lesions. CR is defined as normalization of CA125 levels ((response must be confirmed and maintained for at least 28 days) and disappearance of all target lesions.
Time frame: 18 months post treatment
Time from treatment until disease progression or death
Progression is defined as one of the following: * Patients with elevated CA-125 pretreatment and normalization of CA-125 must show evidence of CA-125 greater than, or equal to, 2 times the upper limit of the reference range on 2 occasions at least 1 week apart or * Patients with elevated CA-125 before treatment, which never normalizes, must show evidence of CA-125 greater than, or equal to, 2 times the nadir value on 2 occasions at least 1 week apart or * Patients with CA-125 in the reference range before treatment must show evidence of CA-125 greater than, or equal to, 2 times the upper limit of the reference range on 2 occasions at least 1 week apart * Increase in at least 20% in sum of diameters of target lesions or any new lesions or unequivocal increase in non-target lesions. * Response determined via measurable disease (measurement of target and non-target lesions) takes precedence over CA125 criteria Stable Disease (SD): CA
Time frame: 18 months post treatment
Number of participants encountering toxicity at each dose level
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UPMC Hillman Cancer Center Arnold Palmer Medical at Norwin
Irwin, Pennsylvania, United States
UPMC Hillman Cancer Center Arnold Palmer at Mt Pleasant
Mount Pleasant, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
UPMC Hillman Cancer Center Passavant (OHA)
Pittsburgh, Pennsylvania, United States
UPMC Hillman Cancer Center Washington
Washington, Pennsylvania, United States
Patients will potentially be treated with 3 different dose levels of ribociclib in combination with platinum-based chemotherapy.
Time frame: 30 days post treatment
Overall Survival (OS)
The (median) length of time from start of treatment patients are still alive.
Time frame: Up to 5 years