Trial Outcomes & Findings for Lapatinib and Capecitabine for Second Line Treatment of Pancreas Cancer (NCT NCT00881621)

Results Overview

Time of study entry to time of death

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

17 participants

Primary outcome timeframe

24 months

Results posted on

2025-03-03

Participant Flow

Due to change of practice, it is difficult to complete the enrollment for the study

Participant milestones

Participant milestones
Measure	Lapatinib and Capecitabine Treatment Lapatinib and Capecitabine: Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles
Overall Study STARTED	51
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	34

Reasons for withdrawal

Reasons for withdrawal
Measure	Lapatinib and Capecitabine Treatment Lapatinib and Capecitabine: Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles
Overall Study Physician Decision	34

Baseline Characteristics

Lapatinib and Capecitabine for Second Line Treatment of Pancreas Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lapatinib and Capecitabine n=17 Participants Treatment Lapatinib and Capecitabine: Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles
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	4 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
ECOG ECOG PS 0	3 participants n=5 Participants
ECOG ECOG PS 1	12 participants n=5 Participants
ECOG ECOG PS2	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Time of study entry to time of death

Outcome measures

Outcome measures
Measure	Lapatinib and Capecitabine n=17 Participants Treatment Lapatinib and Capecitabine: Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles
Overall Survival	5.2 months Interval 3.4 to 9.0

SECONDARY outcome

Timeframe: 3 months

number of participants who had stable disease or partial response or complete response per Response Evaluation Criteria In Solid Tumors. Complete Response: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Outcome measures

Outcome measures
Measure	Lapatinib and Capecitabine n=17 Participants Treatment Lapatinib and Capecitabine: Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles
Clinical Benefit Response	6 participants

SECONDARY outcome

Timeframe: 24 months

Population: Time of study entry to disease progression.

Time of study entry to cancer progression.

Outcome measures

Outcome measures
Measure	Lapatinib and Capecitabine n=17 Participants Treatment Lapatinib and Capecitabine: Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles
Progression Free Survival	2.6 months Interval 1.3 to 3.8

SECONDARY outcome

Timeframe: 2 years

Population: grade 3 or 4 toxicities

Grade 3 or 4 toxicities

Outcome measures

Outcome measures
Measure	Lapatinib and Capecitabine n=17 Participants Treatment Lapatinib and Capecitabine: Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles
Adverse Events	3 participants

Adverse Events

Lapatinib and Capecitabine

Serious events: 5 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Lapatinib and Capecitabine n=17 participants at risk Treatment Lapatinib and Capecitabine: Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles
General disorders fatigue	5.9% 1/17 • Number of events 1 • 2 years
Gastrointestinal disorders nausea, vomiting	11.8% 2/17 • Number of events 2 • 2 years
Gastrointestinal disorders diarrhea	11.8% 2/17 • Number of events 2 • 2 years

Other adverse events

Other adverse events
Measure	Lapatinib and Capecitabine n=17 participants at risk Treatment Lapatinib and Capecitabine: Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles
General disorders fatigue	41.2% 7/17 • Number of events 7 • 2 years
General disorders anorexia	5.9% 1/17 • Number of events 1 • 2 years
Gastrointestinal disorders nausea vomiting	5.9% 1/17 • Number of events 1 • 2 years
Gastrointestinal disorders diarrhea	29.4% 5/17 • Number of events 5 • 2 years
Skin and subcutaneous tissue disorders hand-foot syndrome	17.6% 3/17 • Number of events 3 • 2 years
Skin and subcutaneous tissue disorders skin rash	11.8% 2/17 • Number of events 2 • 2 years
Nervous system disorders sensort neuropathy	5.9% 1/17 • Number of events 1 • 2 years
Gastrointestinal disorders stomatitis	11.8% 2/17 • Number of events 2 • 2 years
Blood and lymphatic system disorders thrombocytopenia	11.8% 2/17 • Number of events 2 • 2 years

Additional Information

Dr. Aiwu Ruth He

Georgetown University

Phone: 202-444-8642

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60