4 cycles of induction treatment with nab-paclitaxel and carboplatin followed by nab-paclitaxel monotherapy for those subjects who are progression free at the end of 4 cycles.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
University Cancer Institute
Boynton Beach, Florida, United States
Ochsner Clinic Nephrology
New Orleans, Louisiana, United States
Henry Ford Health System
Detroit, Michigan, United States
University of RochesterJames P. Wilmont Cancer Center
Percentage of Participants Who Discontinued Study Treatment During the Induction Period Due to Treatment Emergent Adverse Events (TEAEs).
Treatment-emergent adverse events were defined as any adverse event (AE) or serious adverse event (SAE) that occurred or worsened on or after the day of the first dose of the investigational product through 28 days after the last dose of IP. In addition, any SAE with an onset date more than 28 day after the last dose of IP that was assessed by the investigator as related to IP was considered a TEAE. A participant met the primary endpoint if: an AE was the reason for discontinuation as recorded in the electronic Case Report Form (eCRF) and the participant had no doses administered beyond Cycle 4. 95% confidence interval for the percentage was calculated using the Clopper Pearson method.
Time frame: From date of the first dose of IP until 28 days after the last dose of IP during induction and SAEs made known to the investigator any time thereafter that are suspected of being related to IP; maximum treatment duration during induction was 3.9 months
Percentage of Participants Who Discontinued Study Treatment During the Induction Period (Discontinuation Rate)
Discontinuation Rate was measured as Percentage of Participants who Discontinued Study Treatment During the Induction Period
Time frame: From date of the first dose of IP until 28 days after the last dose of IP during induction and SAEs made known to the investigator any time thereafter that are suspected of being related to IP; maximum treatment duration during induction was 3.9 months
Dose Intensity of Nab-Paclitaxel During the Entire Study
Dose intensity for nab-paclitaxel during the entire study period was (mg/m\^2/week) = \[cumulative dose for nab-paclitaxel in mg/m\^2\] / \[nab-paclitaxel dosing period in weeks\]
Time frame: From Day 1 of study treatment to end of study treatment; maximum treatment duration on study was 14.1 months
Dose Intensity of Carboplatin During the Entire Study
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Rochester, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Dose intensity for carboplatin during the entire study period was (mg\*min/mL/week) = \[cumulative dose for carboplatin in mg\*min/mL\] / \[carboplatin dosing period in weeks\].
Time frame: From Day 1 of study treatment to end of study treatment; maximum treatment duration on study was 14.1 months
Percentage of Participants With Dose Reductions During the Entire Study
A dose reduction occurs when the dose assigned at a visit was lower than the dose assigned at the previous visit. Dose reductions are typically caused by clinically significant laboratory abnormalities and/or treatment emergent adverse events or toxicities.
Time frame: From day 1 of IP until 28 days after the last dose of IP; maximum treatment duration was 14.1 months during the entire study
Kaplan Meier Estimate of Progression-Free Survival (PFS)
Progression-free survival was defined as the time in months from day 1 of treatment to the date of disease progression based on the investigator's assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria (documented by radiological assessment) or death (any cause) on or prior to the clinical cut-off date, which ever occurred earlier. RECIST V1.1 criteria includes: - Complete Response (CR) is the disappearance of all target lesions; - Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions from baseline; - Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease (PD); - Progressive Disease is at least a 20% increase in the sum of diameters of target lesions from nadir
Time frame: From Day 1 of study drug treatment to the date of disease progression; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months
Percentage of Participants Who Achieved a Complete Response or Partial Response or Continued Stable Disease (Disease Control Rate)
Disease control rate was defined as the percentage of participants who had continued stable disease, complete or partial response during the course of the study, according to RECIST v1.1 guidelines, as evaluated by the investigator. RECIST V1.1 criteria includes: - Complete Response is the disappearance of all target lesions; - Partial Response is at least a 30% decrease in the sum of diameters of target lesions from baseline; - Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease; - Progressive Disease is at least a 20% increase in the sum of diameters of target lesions from nadir
Time frame: Response assessments were evaluated every 6 weeks; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months
Kaplan Meier Estimate of Overall Survival (OS)
Overall survival was defined as the time in months between day 1 of treatment and death from any cause). Participants who were still alive as of the clinical cut-off date had their OS censored at the date of last contact or clinical cut-off, whichever was earlier. Participants who were lost to follow-up prior to the end of the study or who were withdrawn from the study were censored at the time of last contact.
Time frame: From Day 1 of study treatment to death from any cause; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months
Percentage of Participants Who Achieved a Best Overall Response of Complete Response or Partial Response According to RECIST 1.1 Guidelines
Overall tumor response is defined as the percentage of participants who achieved an objective confirmed CR (the disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions from baseline) according to RECIST V1.1 guidelines, compared with baseline where baseline was the last computed tomography (CT) scan obtained prior to or on Day 1 of study treatment.
Time frame: Response assessments were evaluated every 2 cycles; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months
Time to Response
Time to response was defined as the time from Day 1 of study treatment to the first occurrence of response (CR or PR) according to RECIST v1.1 guidelines. RECIST V1.1 criteria includes: - A Complete Response (CR) is the disappearance of all target lesions; - A Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions from baseline
Time frame: From Day 1 of study drug treatment to the date of first occurrence of CR or PR; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months
Kaplan Meier Estimate of Duration of Response
Duration of overall response was measured from the time measurement criteria were first met for CR (the disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions from baseline), whichever was first recorded, until the first date that recurrent disease or PD (at least a 20% increase in the sum of diameters of target lesions from nadir) was radiologically documented (taking as reference for PD the smallest measurements recorded on study). Median and 95% CI were estimated based on the Kaplan-Meier method.
Time frame: From Day 1 of study drug treatment to the date of first occurrence of CR or PR; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months
Number of Participants With TEAEs During the Induction and Monotherapy Periods
Treatment-emergent adverse events were defined as any adverse event or serious adverse event that occurred or worsened on or after the day of the first dose of the IP through 28 days after the last dose of IP. In addition, any SAE with an onset date more than 28 day after the last dose of IP that was assessed by the investigator as related to IP was considered a TEAE. The severity of AEs were graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and the scale: Grade 1 = Mild l intervention/therapy required Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death.
Time frame: From date of the first dose of IP until 28 days after the last IP dose and SAEs made known to the investigator any time thereafter that are suspected of being related to IP; up to cutoff date of 24 Feb 2017; maximum treatment duration was 14.1 months