Trial Outcomes & Findings for Lapatinib Ditosylate in Treating Patients With Unresectable Liver or Biliary Tract Cancer (NCT NCT00107536)

Last Updated: 2015-04-29

Results Overview

PR (Partial Response) definded as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. CR (Complete Response) is defined as the disappearance of all target lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

26 participants

Primary outcome timeframe

Up to 3 years

Results posted on

2015-04-29

Participant Flow

Patients were enrolled between the dates of March 3, 2006-May 14, 2007.

Participant milestones

Participant milestones
Measure	Lapatinib Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate laboratory biomarker analysis: Correlative studies
Overall Study STARTED	26
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lapatinib Ditosylate in Treating Patients With Unresectable Liver or Biliary Tract Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I n=26 Participants Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate laboratory biomarker analysis: Correlative studies
Age, Continuous	58 years n=39 Participants
Sex: Female, Male Female	8 Participants n=39 Participants
Sex: Female, Male Male	18 Participants n=39 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=39 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=39 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=39 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants
Race (NIH/OMB) Asian	1 Participants n=39 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants
Race (NIH/OMB) Black or African American	4 Participants n=39 Participants
Race (NIH/OMB) White	20 Participants n=39 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=39 Participants
Region of Enrollment United States	26 participants n=39 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status Performance status 0	12 participants n=39 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status Performance status 1	14 participants n=39 Participants
Sites of metastasis Lymph nodes	8 participants n=39 Participants
Sites of metastasis Lungs	8 participants n=39 Participants
Sites of metastasis Spine	1 participants n=39 Participants
Sites of metastasis Bone	1 participants n=39 Participants
Sites of metastasis Adrenal gland	1 participants n=39 Participants
Sites of metastasis Peritoneal mets	1 participants n=39 Participants
Sites of metastasis Hepatic mets	1 participants n=39 Participants
Sites of metastasis Chest wall	1 participants n=39 Participants
Sites of metastasis Not available	4 participants n=39 Participants
Prior treatments X-ray treatment	3 participants n=39 Participants
Prior treatments Chemo-embolization	2 participants n=39 Participants
Prior treatments Surgery	16 participants n=39 Participants
Prior treatments Chemotherapy	3 participants n=39 Participants
Prior treatments Unknown	2 participants n=39 Participants

PRIMARY outcome

Timeframe: Up to 3 years

Population: Only 25 patients were evaluable for response (1 patient passed away before staging).

Outcome measures

Outcome measures
Measure	Arm I n=25 Participants Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate laboratory biomarker analysis: Correlative studies
Proportion of Patients Demonstrating Objective Response (PR+CR) as Defined by RECIST	0 patients

SECONDARY outcome

Timeframe: up to 6 months

Outcome measures

Outcome measures
Measure	Arm I n=26 Participants Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate laboratory biomarker analysis: Correlative studies
Progression-free Survival	1.9 months Interval 1.8 to 3.6

SECONDARY outcome

Timeframe: Up to 3 years

Population: All 26 patients were evaluable for toxicity analysis.

Percentage of patients with Adverse events accordng to NCI CTCAE version 3.0

Outcome measures

Outcome measures
Measure	Arm I n=26 Participants Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate laboratory biomarker analysis: Correlative studies
Toxicity Profile Assessed Using NCI CTCAE Version 3.0 Diarrhea	73 percentage of patients
Toxicity Profile Assessed Using NCI CTCAE Version 3.0 Nausea	54 percentage of patients
Toxicity Profile Assessed Using NCI CTCAE Version 3.0 Rash	50 percentage of patients

SECONDARY outcome

Timeframe: Up to 3 years

Outcome measures

Outcome measures
Measure	Arm I n=26 Participants Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate laboratory biomarker analysis: Correlative studies
Median Overall Survival	12.6 months Interval 7.8 to 22.4

SECONDARY outcome

Timeframe: up to 12.6 months

Outcome measures

Outcome measures
Measure	Arm I n=26 Participants Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate laboratory biomarker analysis: Correlative studies
Overall Survival	12.6 months Interval 7.8 to 22.4

SECONDARY outcome

Timeframe: Up to 3 years

EGFR (exons 18-21)

Outcome measures

Outcome measures
Measure	Arm I n=26 Participants Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate laboratory biomarker analysis: Correlative studies
Target-EGFR/EGFR-P Protein Expression	0 patients with somatic mutations

SECONDARY outcome

Timeframe: Up to 3 years

Outcome measures

Outcome measures
Measure	Arm I n=24 Participants Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate laboratory biomarker analysis: Correlative studies
Expression Profile and Mutations of Genes Critical for EGFR and ERBB2 Signaling Pathways	0 patients with mutations

Adverse Events

Arm I

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Arm I n=26 participants at risk Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate laboratory biomarker analysis: Correlative studies
Gastrointestinal disorders Diarrhea	73.1% 19/26 • Number of events 19 • Week 1 through end of study evaluation The NCI Common Terminology Criteria for Adverse Events v3.0 was utilized for Adverse Event (AE) reporting.
Gastrointestinal disorders Nausea	53.8% 14/26 • Number of events 14 • Week 1 through end of study evaluation The NCI Common Terminology Criteria for Adverse Events v3.0 was utilized for Adverse Event (AE) reporting.
General disorders Fatigue	42.3% 11/26 • Number of events 11 • Week 1 through end of study evaluation The NCI Common Terminology Criteria for Adverse Events v3.0 was utilized for Adverse Event (AE) reporting.
Gastrointestinal disorders Vomiting	26.9% 7/26 • Number of events 7 • Week 1 through end of study evaluation The NCI Common Terminology Criteria for Adverse Events v3.0 was utilized for Adverse Event (AE) reporting.
Investigations Alkaline phosphatase	19.2% 5/26 • Number of events 5 • Week 1 through end of study evaluation The NCI Common Terminology Criteria for Adverse Events v3.0 was utilized for Adverse Event (AE) reporting.
Investigations ALT, SGPT (serum glutamic pyruvic transaminase)	19.2% 5/26 • Number of events 5 • Week 1 through end of study evaluation The NCI Common Terminology Criteria for Adverse Events v3.0 was utilized for Adverse Event (AE) reporting.
Investigations AST, SGOT(serum glutamic oxaloacetic transaminase)	15.4% 4/26 • Number of events 4 • Week 1 through end of study evaluation The NCI Common Terminology Criteria for Adverse Events v3.0 was utilized for Adverse Event (AE) reporting.
Blood and lymphatic system disorders Hemoglobin	15.4% 4/26 • Number of events 4 • Week 1 through end of study evaluation The NCI Common Terminology Criteria for Adverse Events v3.0 was utilized for Adverse Event (AE) reporting.
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	11.5% 3/26 • Number of events 3 • Week 1 through end of study evaluation The NCI Common Terminology Criteria for Adverse Events v3.0 was utilized for Adverse Event (AE) reporting.
Investigations Leukocytes (total WBC)	7.7% 2/26 • Number of events 2 • Week 1 through end of study evaluation The NCI Common Terminology Criteria for Adverse Events v3.0 was utilized for Adverse Event (AE) reporting.
Metabolism and nutrition disorders Anorexia	11.5% 3/26 • Number of events 3 • Week 1 through end of study evaluation The NCI Common Terminology Criteria for Adverse Events v3.0 was utilized for Adverse Event (AE) reporting.
Investigations Creatinine	7.7% 2/26 • Number of events 2 • Week 1 through end of study evaluation The NCI Common Terminology Criteria for Adverse Events v3.0 was utilized for Adverse Event (AE) reporting.
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	7.7% 2/26 • Number of events 2 • Week 1 through end of study evaluation The NCI Common Terminology Criteria for Adverse Events v3.0 was utilized for Adverse Event (AE) reporting.
Skin and subcutaneous tissue disorders Pruritus/itching	7.7% 2/26 • Number of events 2 • Week 1 through end of study evaluation The NCI Common Terminology Criteria for Adverse Events v3.0 was utilized for Adverse Event (AE) reporting.
Gastrointestinal disorders Gastritis (including bile reflux gastritis)	7.7% 2/26 • Number of events 2 • Week 1 through end of study evaluation The NCI Common Terminology Criteria for Adverse Events v3.0 was utilized for Adverse Event (AE) reporting.
Skin and subcutaneous tissue disorders Rash	50.0% 13/26 • Number of events 13 • Week 1 through end of study evaluation The NCI Common Terminology Criteria for Adverse Events v3.0 was utilized for Adverse Event (AE) reporting.

Additional Information

Tanio Bekaii-Saab, MD

The Ohio State University Comprehensive Cancer Center

Phone: 614-293-9863

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60