Trial Outcomes & Findings for Capecitabine (Xeloda) and Lapatinib (Tykerb) as First-line Therapy in HER2/Neu-positive Breast Cancer (NCT NCT00496366)
NCT ID: NCT00496366
Last Updated: 2017-03-21
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
2 years
Results posted on
2017-03-21
Participant Flow
We are reporting results on 11 subjects enrolled, who were recruited from July 2007 through December 2009. Subjects were recruited through the Cancer Institute of New Jersey's Oncology Group and this study was closed pre-maturely due to slow accrual.
Participant milestones
| Measure |
Capecitabine (Xeloda) + Lapatinib (Tykerb)
Capecitabine for 2 weeks straight (Days 1-14) followed by 1 week without capecitabine (Days 15-21).
Lapatinib will be taken daily continuously for 21 days (Days 1- 21).
Capecitabine: The dose of capecitabine is 1000 mg/m2/dose twice each day, orally, 12 hours apart, for 14 consecutive days, every 21 days (total daily dose = 2000 mg/m2).
Lapatinib: The daily dose of lapatinib is 1250 mg (5 tablets of 250 mg each) to be taken at approximately the same time each day, continuously. Lapatinib is taken even during the week that capecitabine is not taken.
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Capecitabine (Xeloda) + Lapatinib (Tykerb)
Capecitabine for 2 weeks straight (Days 1-14) followed by 1 week without capecitabine (Days 15-21).
Lapatinib will be taken daily continuously for 21 days (Days 1- 21).
Capecitabine: The dose of capecitabine is 1000 mg/m2/dose twice each day, orally, 12 hours apart, for 14 consecutive days, every 21 days (total daily dose = 2000 mg/m2).
Lapatinib: The daily dose of lapatinib is 1250 mg (5 tablets of 250 mg each) to be taken at approximately the same time each day, continuously. Lapatinib is taken even during the week that capecitabine is not taken.
|
|---|---|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Capecitabine (Xeloda) and Lapatinib (Tykerb) as First-line Therapy in HER2/Neu-positive Breast Cancer
Baseline characteristics by cohort
| Measure |
Capecitabine (Xeloda) + Lapatinib (Tykerb)
n=11 Participants
Capecitabine for 2 weeks straight (Days 1-14) followed by 1 week without capecitabine (Days 15-21).
Lapatinib will be taken daily continuously for 21 days (Days 1- 21).
Capecitabine: The dose of capecitabine is 1000 mg/m2/dose twice each day, orally, 12 hours apart, for 14 consecutive days, every 21 days (total daily dose = 2000 mg/m2).
Lapatinib: The daily dose of lapatinib is 1250 mg (5 tablets of 250 mg each) to be taken at approximately the same time each day, continuously. Lapatinib is taken even during the week that capecitabine is not taken.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=93 Participants
|
|
Age, Continuous
|
60.7 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Study to was terminated early and insufficient data was collected to assess this outcome measure.
Outcome measures
| Measure |
Capecitabine (Xeloda) + Lapatinib (Tykerb)
Capecitabine for 2 weeks straight (Days 1-14) followed by 1 week without capecitabine (Days 15-21).
Lapatinib will be taken daily continuously for 21 days (Days 1- 21).
Capecitabine: The dose of capecitabine is 1000 mg/m2/dose twice each day, orally, 12 hours apart, for 14 consecutive days, every 21 days (total daily dose = 2000 mg/m2).
Lapatinib: The daily dose of lapatinib is 1250 mg (5 tablets of 250 mg each) to be taken at approximately the same time each day, continuously. Lapatinib is taken even during the week that capecitabine is not taken.
|
|---|---|
|
Determine the Response Rate (as Determined by RECIST Criteria) of Capecitabine and Lapatinib as First-line Therapy in Patients With Advanced or Metastatic Breast Cancer That Overexpress HER2.
|
0
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Study was terminated early and insufficient data was collected to assess this outcome measure.
Outcome measures
| Measure |
Capecitabine (Xeloda) + Lapatinib (Tykerb)
Capecitabine for 2 weeks straight (Days 1-14) followed by 1 week without capecitabine (Days 15-21).
Lapatinib will be taken daily continuously for 21 days (Days 1- 21).
Capecitabine: The dose of capecitabine is 1000 mg/m2/dose twice each day, orally, 12 hours apart, for 14 consecutive days, every 21 days (total daily dose = 2000 mg/m2).
Lapatinib: The daily dose of lapatinib is 1250 mg (5 tablets of 250 mg each) to be taken at approximately the same time each day, continuously. Lapatinib is taken even during the week that capecitabine is not taken.
|
|---|---|
|
-Determine the Clinical Benefit Rate (Complete Response, Partial Response, or Stable Disease for at Least 6 Months) of Capecitabine and Lapatinib. -Determine Time to Disease Progression After Treatment With Capecitabine and Lapatinib. -Evaluate Overall
|
0
|
Adverse Events
Capecitabine (Xeloda) + Lapatinib (Tykerb)
Serious events: 3 serious events
Other events: 11 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Capecitabine (Xeloda) + Lapatinib (Tykerb)
n=11 participants at risk
Capecitabine for 2 weeks straight (Days 1-14) followed by 1 week without capecitabine (Days 15-21).
Lapatinib will be taken daily continuously for 21 days (Days 1- 21).
Capecitabine: The dose of capecitabine is 1000 mg/m2/dose twice each day, orally, 12 hours apart, for 14 consecutive days, every 21 days (total daily dose = 2000 mg/m2).
Lapatinib: The daily dose of lapatinib is 1250 mg (5 tablets of 250 mg each) to be taken at approximately the same time each day, continuously. Lapatinib is taken even during the week that capecitabine is not taken.
|
|---|---|
|
Infections and infestations
Sepsis
|
9.1%
1/11 • Number of events 1
|
|
Infections and infestations
Death
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
18.2%
2/11 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11 • Number of events 1
|
Other adverse events
| Measure |
Capecitabine (Xeloda) + Lapatinib (Tykerb)
n=11 participants at risk
Capecitabine for 2 weeks straight (Days 1-14) followed by 1 week without capecitabine (Days 15-21).
Lapatinib will be taken daily continuously for 21 days (Days 1- 21).
Capecitabine: The dose of capecitabine is 1000 mg/m2/dose twice each day, orally, 12 hours apart, for 14 consecutive days, every 21 days (total daily dose = 2000 mg/m2).
Lapatinib: The daily dose of lapatinib is 1250 mg (5 tablets of 250 mg each) to be taken at approximately the same time each day, continuously. Lapatinib is taken even during the week that capecitabine is not taken.
|
|---|---|
|
General disorders
Fatigue
|
36.4%
4/11 • Number of events 9
|
|
Investigations
Weight loss
|
9.1%
1/11 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
54.5%
6/11 • Number of events 19
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
9.1%
1/11 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
45.5%
5/11 • Number of events 11
|
|
Nervous system disorders
Dysgeusia
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
45.5%
5/11 • Number of events 8
|
|
Gastrointestinal disorders
Vomiting
|
27.3%
3/11 • Number of events 5
|
|
Metabolism and nutrition disorders
Anorexia
|
27.3%
3/11 • Number of events 4
|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis - oral
|
27.3%
3/11 • Number of events 3
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophiles
|
18.2%
2/11 • Number of events 4
|
|
Infections and infestations
Infection with unknown ANC
|
18.2%
2/11 • Number of events 2
|
|
Investigations
Alanine aminotransferase increased
|
9.1%
1/11 • Number of events 2
|
|
Investigations
Aspartate aminotransferase increased
|
9.1%
1/11 • Number of events 2
|
|
Investigations
Blood bilirubin increased
|
9.1%
1/11 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalemia
|
9.1%
1/11 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
9.1%
1/11 • Number of events 1
|
Additional Information
Deborah Toppmeyer, MD
Rutgers Cancer Institute of New Jersey
Phone: 732-235-6789
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place