Trial Outcomes & Findings for Weight-based Dosing for Dense Weekly Paclitaxel and Carboplatin in Overweight Patients w/ Body Surface Area (BSA) > 2.0 (NCT NCT02756013)
NCT ID: NCT02756013
Last Updated: 2022-06-30
Results Overview
Prospective evaluation of the Relative Dose Intensity (RDI) of weight-based dose dense weekly paclitaxel and carboplatin as measured by the average percent of completed treatment cycles out of the intended therapeutic plan
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
Up to 190 days
Results posted on
2022-06-30
Participant Flow
Participant milestones
| Measure |
Paclitaxel + Carboplatin
Paclitaxel dosed by actual body surface area (BSA) and not maxed at BSA 2.0. The Carboplatin dose will be calculated according to the Calvert formula using as estimated glomerular filtration rate from the Cockcroft-Gault formula and will be subject to maximum allowed doses.
Paclitaxel: 80mg/m2 IV days 1,8, and 15 every 21 days x 6-9 cycles
Carboplatin: area under the curve (AUC) 6 IV day 1 every 21 days x 6-9 cycles
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Paclitaxel + Carboplatin
Paclitaxel dosed by actual body surface area (BSA) and not maxed at BSA 2.0. The Carboplatin dose will be calculated according to the Calvert formula using as estimated glomerular filtration rate from the Cockcroft-Gault formula and will be subject to maximum allowed doses.
Paclitaxel: 80mg/m2 IV days 1,8, and 15 every 21 days x 6-9 cycles
Carboplatin: area under the curve (AUC) 6 IV day 1 every 21 days x 6-9 cycles
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Hypersensitivity
|
1
|
Baseline Characteristics
Weight-based Dosing for Dense Weekly Paclitaxel and Carboplatin in Overweight Patients w/ Body Surface Area (BSA) > 2.0
Baseline characteristics by cohort
| Measure |
Paclitaxel + Carboplatin
n=3 Participants
Paclitaxel dosed by actual body surface area and not maxed at BSA 2.0. The Carboplatin dose will be calculated according to the Calvert formula using as estimated glomerular filtration rate from the Cockcroft-Gault formula and will be subject to maximum allowed doses.
Paclitaxel: 80mg/m2 IV days 1,8, and 15 every 21 days x 6-9 cycles
Carboplatin: area under the curve (AUC) 6 IV day 1 every 21 days x 6-9 cycles
|
|---|---|
|
Age, Customized
50-59 years
|
2 Participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 190 daysPopulation: Participants who received treatment
Prospective evaluation of the Relative Dose Intensity (RDI) of weight-based dose dense weekly paclitaxel and carboplatin as measured by the average percent of completed treatment cycles out of the intended therapeutic plan
Outcome measures
| Measure |
Paclitaxel + Carboplatin
n=2 Participants
Paclitaxel dosed by actual body surface area and not maxed at BSA 2.0. The Carboplatin dose will be calculated according to the Calvert formula using as estimated glomerular filtration rate from the Cockcroft-Gault formula and will be subject to maximum allowed doses.
Paclitaxel: 80mg/m2 IV days 1,8, and 15 every 21 days x 6-9 cycles
Carboplatin: area under the curve (AUC) 6 IV day 1 every 21 days x 6-9 cycles
|
|---|---|
|
Relative Dose Intensity as Measured by Mean Percent of Intended Cycles Completed
|
77.5 percent of intended cycles completed
Interval 66.0 to 89.0
|
SECONDARY outcome
Timeframe: every 3 months for up to 2 years, then every 6 months (up to 31 months)Population: Participants enrolled in study. Long Term Follow Up stopped after termination of study due to low accrual.
Progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Paclitaxel + Carboplatin
n=3 Participants
Paclitaxel dosed by actual body surface area and not maxed at BSA 2.0. The Carboplatin dose will be calculated according to the Calvert formula using as estimated glomerular filtration rate from the Cockcroft-Gault formula and will be subject to maximum allowed doses.
Paclitaxel: 80mg/m2 IV days 1,8, and 15 every 21 days x 6-9 cycles
Carboplatin: area under the curve (AUC) 6 IV day 1 every 21 days x 6-9 cycles
|
|---|---|
|
Number of Participants With Progression-free Survival (PFS)
3 months
|
3 Participants
|
|
Number of Participants With Progression-free Survival (PFS)
6 months
|
3 Participants
|
|
Number of Participants With Progression-free Survival (PFS)
9 months
|
2 Participants
|
|
Number of Participants With Progression-free Survival (PFS)
12 months
|
2 Participants
|
|
Number of Participants With Progression-free Survival (PFS)
15 months
|
2 Participants
|
|
Number of Participants With Progression-free Survival (PFS)
18 months
|
2 Participants
|
|
Number of Participants With Progression-free Survival (PFS)
21 months
|
2 Participants
|
|
Number of Participants With Progression-free Survival (PFS)
24 months
|
2 Participants
|
|
Number of Participants With Progression-free Survival (PFS)
31 months
|
2 Participants
|
Adverse Events
Paclitaxel + Carboplatin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Paclitaxel + Carboplatin
n=3 participants at risk
Paclitaxel dosed by actual body surface area and not maxed at BSA 2.0. The Carboplatin dose will be calculated according to the Calvert formula using as estimated glomerular filtration rate from the Cockcroft-Gault formula and will be subject to maximum allowed doses.
Paclitaxel: 80mg/m2 IV days 1,8, and 15 every 21 days x 6-9 cycles
Carboplatin: area under the curve (AUC) 6 IV day 1 every 21 days x 6-9 cycles
|
|---|---|
|
Nervous system disorders
Peripheral neuropathy
|
33.3%
1/3 • Number of events 1 • Before each treatment, up to 189 days (21 day cycles, up to 9 cycles)
|
Additional Information
Dr. Peter Rose
Cleveland Clinic, Case Comprehensive Cancer Center
Phone: +1 216-444-6601
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place