Trial Outcomes & Findings for Capecitabine Pharmacokinetics(PK)-Actual Versus Ideal Body Weight (NCT NCT01828554)
NCT ID: NCT01828554
Last Updated: 2019-11-25
Results Overview
AUC will be calculated for Capecitabine dosed for Ideal Body Weight during the first cycle (days 1-7) and for Capecitabine dosed for Actual Body Weight for first cycle (days 9-15). \[nonlinear mixed effects modeling approach\]
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
Up to 15 days
Results posted on
2019-11-25
Participant Flow
Participant milestones
| Measure |
Xeloda (Capecitabine)
Cycle 1: Days 1-7 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using "Ideal Body Weight" to calculate dosage. Cycle 1, Day 8-No drug.
Cycle 1: Days 9-15 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage. Days 16-21-No drug.
Cycle 2 and greater: Days 1-14 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage.
Xeloda: Cycle 1: Days 1-7 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using "Ideal Body Weight" to calculate dosage. Cycle 1, Day 8-No drug.
Cycle 1: Days 9-15 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage. Days 16-21-No drug.
Cycle 2 and greater: Days 1-14 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Capecitabine Pharmacokinetics(PK)-Actual Versus Ideal Body Weight
Baseline characteristics by cohort
| Measure |
Xeloda (Capecitabine)
n=8 Participants
Cycle 1: Days 1-7 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using "Ideal Body Weight" to calculate dosage. Cycle 1, Day 8-No drug.
Cycle 1: Days 9-15 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage. Days 16-21-No drug.
Cycle 2 and greater: Days 1-14 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage.
Xeloda: Cycle 1: Days 1-7 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using "Ideal Body Weight" to calculate dosage. Cycle 1, Day 8-No drug.
Cycle 1: Days 9-15 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage. Days 16-21-No drug.
Cycle 2 and greater: Days 1-14 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage.
|
|---|---|
|
Age, Customized
40-49 years
|
1 Participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
2 Participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
4 Participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 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
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 15 daysAUC will be calculated for Capecitabine dosed for Ideal Body Weight during the first cycle (days 1-7) and for Capecitabine dosed for Actual Body Weight for first cycle (days 9-15). \[nonlinear mixed effects modeling approach\]
Outcome measures
| Measure |
Xeloda (Capecitabine)
n=8 Participants
Cycle 1: Days 1-7 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using "Ideal Body Weight" to calculate dosage. Cycle 1, Day 8-No drug.
Cycle 1: Days 9-15 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage. Days 16-21-No drug.
Cycle 2 and greater: Days 1-14 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage.
Xeloda: Cycle 1: Days 1-7 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using "Ideal Body Weight" to calculate dosage. Cycle 1, Day 8-No drug.
Cycle 1: Days 9-15 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage. Days 16-21-No drug.
Cycle 2 and greater: Days 1-14 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage.
|
|---|---|
|
Area Under the Curve (AUC) on Cycle 1 Day 1 and Cycle 1 Day 9
Cycle 1 Day 1
|
6.84 AUC (ug/ml)*h
Standard Deviation 7.89
|
|
Area Under the Curve (AUC) on Cycle 1 Day 1 and Cycle 1 Day 9
Cycle 1 Day 9
|
8.28 AUC (ug/ml)*h
Standard Deviation 6.64
|
PRIMARY outcome
Timeframe: Up to 15 daysCmax will be reported for Capecitabine dosed for Ideal Body Weight during the first cycle (days 1-7) and for Capecitabine dosed for Actual Body Weight for first cycle (days 9-15). \[nonlinear mixed effects modeling approach\]
Outcome measures
| Measure |
Xeloda (Capecitabine)
n=8 Participants
Cycle 1: Days 1-7 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using "Ideal Body Weight" to calculate dosage. Cycle 1, Day 8-No drug.
Cycle 1: Days 9-15 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage. Days 16-21-No drug.
Cycle 2 and greater: Days 1-14 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage.
Xeloda: Cycle 1: Days 1-7 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using "Ideal Body Weight" to calculate dosage. Cycle 1, Day 8-No drug.
Cycle 1: Days 9-15 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage. Days 16-21-No drug.
Cycle 2 and greater: Days 1-14 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage.
|
|---|---|
|
Cmax During Cycle 1
Cycle 1 Day 1
|
2.44 Cmax (ug/ml)
Standard Deviation 1.89
|
|
Cmax During Cycle 1
Cycle 1 Day 9
|
2.71 Cmax (ug/ml)
Standard Deviation 0.98
|
SECONDARY outcome
Timeframe: Up to 6 monthsResponses will be determined using RECIST v. 1.1 criteria and summarized in tabular format. The complete and partial response rates will be calculated and reported along with the corresponding 95% confidence intervals.
Outcome measures
| Measure |
Xeloda (Capecitabine)
n=8 Participants
Cycle 1: Days 1-7 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using "Ideal Body Weight" to calculate dosage. Cycle 1, Day 8-No drug.
Cycle 1: Days 9-15 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage. Days 16-21-No drug.
Cycle 2 and greater: Days 1-14 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage.
Xeloda: Cycle 1: Days 1-7 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using "Ideal Body Weight" to calculate dosage. Cycle 1, Day 8-No drug.
Cycle 1: Days 9-15 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage. Days 16-21-No drug.
Cycle 2 and greater: Days 1-14 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage.
|
|---|---|
|
Response Rate
|
0 percentage
Interval 0.0 to 32.4
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: The median PFS has not been reached (NBR) within the follow-up period of this trial
Progression-free survival will be analyzed using the Kaplan-Meier method.
Outcome measures
| Measure |
Xeloda (Capecitabine)
n=8 Participants
Cycle 1: Days 1-7 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using "Ideal Body Weight" to calculate dosage. Cycle 1, Day 8-No drug.
Cycle 1: Days 9-15 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage. Days 16-21-No drug.
Cycle 2 and greater: Days 1-14 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage.
Xeloda: Cycle 1: Days 1-7 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using "Ideal Body Weight" to calculate dosage. Cycle 1, Day 8-No drug.
Cycle 1: Days 9-15 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage. Days 16-21-No drug.
Cycle 2 and greater: Days 1-14 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage.
|
|---|---|
|
Progression Free Survival
|
NA months
Interval 1.4 to
The median Progression Free Survival has (PFS) not been reached (NBR) within the follow-up period of this trial
|
Adverse Events
Xeloda (Capecitabine)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Xeloda (Capecitabine)
n=8 participants at risk
Cycle 1: Days 1-7 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using "Ideal Body Weight" to calculate dosage. Cycle 1, Day 8-No drug.
Cycle 1: Days 9-15 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage. Days 16-21-No drug.
Cycle 2 and greater: Days 1-14 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage.
Xeloda: Cycle 1: Days 1-7 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using "Ideal Body Weight" to calculate dosage. Cycle 1, Day 8-No drug.
Cycle 1: Days 9-15 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage. Days 16-21-No drug.
Cycle 2 and greater: Days 1-14 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
75.0%
6/8 • Number of events 15 • up to 9 months
|
|
Gastrointestinal disorders
Constipation
|
37.5%
3/8 • Number of events 3 • up to 9 months
|
|
Gastrointestinal disorders
Diarrhea
|
37.5%
3/8 • Number of events 8 • up to 9 months
|
|
Gastrointestinal disorders
Mucositis oral
|
37.5%
3/8 • Number of events 4 • up to 9 months
|
|
Gastrointestinal disorders
Vomiting
|
37.5%
3/8 • Number of events 5 • up to 9 months
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8 • Number of events 2 • up to 9 months
|
|
Gastrointestinal disorders
Stomach pain
|
12.5%
1/8 • Number of events 1 • up to 9 months
|
|
Gastrointestinal disorders
Toothache
|
12.5%
1/8 • Number of events 1 • up to 9 months
|
|
General disorders
Fatigue
|
50.0%
4/8 • Number of events 4 • up to 9 months
|
|
General disorders
Pain
|
25.0%
2/8 • Number of events 3 • up to 9 months
|
|
General disorders
Edema limbs
|
12.5%
1/8 • Number of events 1 • up to 9 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
75.0%
6/8 • Number of events 9 • up to 9 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
12.5%
1/8 • Number of events 1 • up to 9 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
2/8 • Number of events 3 • up to 9 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
1/8 • Number of events 1 • up to 9 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
12.5%
1/8 • Number of events 1 • up to 9 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
12.5%
1/8 • Number of events 1 • up to 9 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
1/8 • Number of events 2 • up to 9 months
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Number of events 1 • up to 9 months
|
|
Nervous system disorders
Dysgeusia
|
12.5%
1/8 • Number of events 1 • up to 9 months
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Number of events 1 • up to 9 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
12.5%
1/8 • Number of events 1 • up to 9 months
|
|
Infections and infestations
Otitis media
|
12.5%
1/8 • Number of events 1 • up to 9 months
|
|
Infections and infestations
Rhinitis infective
|
12.5%
1/8 • Number of events 1 • up to 9 months
|
|
Infections and infestations
Sinusitis
|
12.5%
1/8 • Number of events 1 • up to 9 months
|
|
Injury, poisoning and procedural complications
Fall
|
25.0%
2/8 • Number of events 2 • up to 9 months
|
|
Metabolism and nutrition disorders
Anorexia
|
12.5%
1/8 • Number of events 3 • up to 9 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
12.5%
1/8 • Number of events 2 • up to 9 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
12.5%
1/8 • Number of events 1 • up to 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
2/8 • Number of events 3 • up to 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8 • Number of events 2 • up to 9 months
|
|
Blood and lymphatic system disorders
Anemia
|
12.5%
1/8 • Number of events 1 • up to 9 months
|
|
Eye disorders
Eye disorders - Other, specify
|
12.5%
1/8 • Number of events 1 • up to 9 months
|
|
Investigations
INR increased
|
12.5%
1/8 • Number of events 3 • up to 9 months
|
|
Renal and urinary disorders
Hematuria
|
12.5%
1/8 • Number of events 1 • up to 9 months
|
|
Vascular disorders
Thromboembolic event
|
12.5%
1/8 • Number of events 1 • up to 9 months
|
Additional Information
Kari B. Wisinski
University of Madison Carbone Cancer Center
Phone: (608) 262-2876
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place