Trial Outcomes & Findings for Phase II Trial of Lapatinib & Capecitabine for Patients With Refractory Advanced Colorectal Adenocarcinoma (NCT NCT00574171)
NCT ID: NCT00574171
Last Updated: 2019-12-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
duration of study; on average 1 year
Results posted on
2019-12-18
Participant Flow
Participant milestones
| Measure |
Lapatinib and Capecitabine
Capecitabine : 2000mg/m2 of body surface area (BSA), by mouth, divided into twice daily dosing. Capecitabine will be given for days 1 through 14 of a 21 day cycle.
lapatinib : 1250mg by mouth daily one hour before or after breakfast on a continuous basis.
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Trial of Lapatinib & Capecitabine for Patients With Refractory Advanced Colorectal Adenocarcinoma
Baseline characteristics by cohort
| Measure |
Arm 1
n=29 Participants
Capecitabine : 2000mg/m2 of body surface area (BSA), by mouth, divided into twice daily dosing. Capecitabine will be given for days 1 through 14 of a 21 day cycle.
lapatinib : 1250mg by mouth daily one hour before or after breakfast on a continuous basis.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: duration of study; on average 1 yearOutcome measures
| Measure |
Lapatinib/Capecitabine
n=29 Participants
lapatinib: 1250mg by mouth daily one hour before or after breakfast on a continuous basis. Capecitabine: 2000mg/m2 of body surface area (BSA), by mouth, divided into twice daily dosing. Capecitabine will be given for days 1 through 14 of a 21 day cycle.
|
|---|---|
|
Response Rate of Lapatinib/Capecitabine.
PD
|
4 participants
|
|
Response Rate of Lapatinib/Capecitabine.
SD
|
1 participants
|
Adverse Events
Arm 1
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1
n=29 participants at risk
Capecitabine : 2000mg/m2 of body surface area (BSA), by mouth, divided into twice daily dosing. Capecitabine will be given for days 1 through 14 of a 21 day cycle.
lapatinib : 1250mg by mouth daily one hour before or after breakfast on a continuous basis.
|
|---|---|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
3.4%
1/29 • Number of events 2
|
|
Gastrointestinal disorders
Obstruction - small bowel, NOS
|
3.4%
1/29 • Number of events 2
|
|
General disorders
Death
|
6.9%
2/29 • Number of events 2
|
|
Cardiac disorders
Hypoxia
|
3.4%
1/29 • Number of events 1
|
|
Gastrointestinal disorders
Infection with normal ANC or Grade 1 or 2 neutrophils - Rectum - Presacral mass
|
3.4%
1/29 • Number of events 1
|
|
General disorders
Sedation from narcotic over dose.
|
3.4%
1/29 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place