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Trial record 44 of 125 for:    lapatinib | Recruiting, Active, not recruiting, Completed Studies | Phase 2

Lapatinib in Treating Patients With Locally Advanced or Metastatic Biliary Tract or Liver Cancer That Cannot Be Removed By Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00101036
Recruitment Status : Completed
First Posted : January 10, 2005
Results First Posted : January 5, 2015
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adult Primary Hepatocellular Carcinoma
Advanced Adult Primary Liver Cancer
Localized Unresectable Adult Primary Liver Cancer
Recurrent Adult Primary Liver Cancer
Recurrent Extrahepatic Bile Duct Cancer
Recurrent Gallbladder Cancer
Unresectable Extrahepatic Bile Duct Cancer
Unresectable Gallbladder Cancer
Interventions Drug: lapatinib ditosylate
Other: laboratory biomarker analysis
Enrollment 57
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description GW572016 1500 mg orally daily for 28 days, Biliary strata GW572016 1500 mg orally daily for 28 days, HCC strata
Period Title: Overall Study
Started 17 40
Completed 17 40
Not Completed 0 0
Arm/Group Title Arm 1 Arm 2 Total
Hide Arm/Group Description GW572016 1500 mg orally daily for 28 days, Biliary strata GW572016 1500 mg orally daily for 28 days, HCC strata Total of all reporting groups
Overall Number of Baseline Participants 17 40 57
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 17 participants 40 participants 57 participants
58
(44 to 76)
62
(19 to 82)
62
(19 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 40 participants 57 participants
Female
13
  76.5%
8
  20.0%
21
  36.8%
Male
4
  23.5%
32
  80.0%
36
  63.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants 40 participants 57 participants
17 40 57
1.Primary Outcome
Title Response Rate
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-Ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:
GW572016 1500 mg orally daily for 28 days, Biliary strata
GW572016 1500 mg orally daily for 28 days, HCC strata
Overall Number of Participants Analyzed 17 40
Measure Type: Number
Unit of Measure: percentage of responding patients
0 5
2.Secondary Outcome
Title Overall Survival
Hide Description Estimated by the Kaplan-Meier method.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:
GW572016 1500 mg orally daily for 28 days, Biliary strata
GW572016 1500 mg orally daily for 28 days, HCC strata
Overall Number of Participants Analyzed 17 40
Median (95% Confidence Interval)
Unit of Measure: Months
5.2 [1] 
(3.3 to NA)
6.2 [1] 
(5.1 to NA)
[1]
The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
3.Secondary Outcome
Title Progression-free Survival
Hide Description Estimated using the Kaplan-Meier method. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:
GW572016 1500 mg orally daily for 28 days, Biliary strata
GW572016 1500 mg orally daily for 28 days, HCC strata
Overall Number of Participants Analyzed 17 40
Median (95% Confidence Interval)
Unit of Measure: Months
1.8
(1.7 to 5.2)
2.3
(1.7 to 5.6)
4.Secondary Outcome
Title Disease Control Rate.
Hide Description

The mathematical sum of percentages of complete response, partial response and stable disease.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions

Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:
GW572016 1500 mg orally daily for 28 days, Biliary strata
GW572016 1500 mg orally daily for 28 days, HCC strata
Overall Number of Participants Analyzed 17 40
Measure Type: Number
Unit of Measure: percentage of participants
26 5
Time Frame Adverse events were collected over a period of 2 years, 3 months.
Adverse Event Reporting Description "Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
 
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description GW572016 1500 mg orally daily for 28 days, Biliary strata GW572016 1500 mg orally daily for 28 days, HCC strata
All-Cause Mortality
Arm 1 Arm 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1 Arm 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/17 (35.29%)      13/40 (32.50%)    
Gastrointestinal disorders     
Abdominal pain * 1  1/17 (5.88%)  1 1/40 (2.50%)  1
Ascites * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Duodenal ulcer * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Esophageal varices hemorrhage * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Lower gastrointestinal hemorrhage * 1  0/17 (0.00%)  0 2/40 (5.00%)  2
Nausea * 1  1/17 (5.88%)  1 0/40 (0.00%)  0
Upper gastrointestinal hemorrhage * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Vomiting * 1  1/17 (5.88%)  1 0/40 (0.00%)  0
General disorders     
Chest pain * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Death * 1  1/17 (5.88%)  1 0/40 (0.00%)  0
Disease progression * 1  1/17 (5.88%)  1 4/40 (10.00%)  4
Fever * 1  1/17 (5.88%)  2 0/40 (0.00%)  0
Pain * 1  1/17 (5.88%)  1 0/40 (0.00%)  0
Hepatobiliary disorders     
Hepatic failure * 1  0/17 (0.00%)  0 1/40 (2.50%)  3
Infections and infestations     
Bone infection * 1  1/17 (5.88%)  2 0/40 (0.00%)  0
Infection * 1  1/17 (5.88%)  1 0/40 (0.00%)  0
Investigations     
Hyperbilirubinemia * 1  1/17 (5.88%)  1 0/40 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration * 1  1/17 (5.88%)  1 0/40 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back pain * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Nervous system disorders     
Encephalopathy * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Vascular disorders     
Thrombosis * 1  2/17 (11.76%)  2 1/40 (2.50%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, meddra9.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1 Arm 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/17 (100.00%)      39/40 (97.50%)    
Blood and lymphatic system disorders     
Hemoglobin decreased * 1  6/17 (35.29%)  9 20/40 (50.00%)  67
Hemolysis * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Lymphatic disorder * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Cardiac disorders     
Left ventricular failure * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Sinus tachycardia * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Ear and labyrinth disorders     
External ear pain * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Eye disorders     
Dry eye syndrome * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Vision blurred * 1  0/17 (0.00%)  0 2/40 (5.00%)  9
Gastrointestinal disorders     
Abdominal pain * 1  4/17 (23.53%)  8 15/40 (37.50%)  25
Ascites * 1  0/17 (0.00%)  0 1/40 (2.50%)  2
Constipation * 1  3/17 (17.65%)  5 9/40 (22.50%)  10
Diarrhea * 1  10/17 (58.82%)  12 26/40 (65.00%)  58
Dry mouth * 1  1/17 (5.88%)  2 3/40 (7.50%)  5
Dyspepsia * 1  1/17 (5.88%)  1 6/40 (15.00%)  17
Dysphagia * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Ear, nose and throat examination abnormal * 1  0/17 (0.00%)  0 2/40 (5.00%)  2
Flatulence * 1  0/17 (0.00%)  0 2/40 (5.00%)  2
Gastritis * 1  1/17 (5.88%)  1 0/40 (0.00%)  0
Gastrointestinal disorder * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Hemorrhoidal hemorrhage * 1  0/17 (0.00%)  0 2/40 (5.00%)  2
Mucositis oral * 1  2/17 (11.76%)  2 4/40 (10.00%)  7
Nausea * 1  9/17 (52.94%)  23 20/40 (50.00%)  32
Rectal hemorrhage * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Stomach pain * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Upper gastrointestinal hemorrhage * 1  0/17 (0.00%)  0 3/40 (7.50%)  3
Vomiting * 1  5/17 (29.41%)  8 9/40 (22.50%)  11
General disorders     
Chest pain * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Disease progression * 1  14/17 (82.35%)  14 22/40 (55.00%)  22
Edema limbs * 1  0/17 (0.00%)  0 5/40 (12.50%)  8
Fatigue * 1  12/17 (70.59%)  21 27/40 (67.50%)  68
Fever * 1  2/17 (11.76%)  2 2/40 (5.00%)  3
Flu-like symptoms * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
General symptom * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Pain * 1  0/17 (0.00%)  0 2/40 (5.00%)  2
Hepatobiliary disorders     
Hepatic pain * 1  0/17 (0.00%)  0 2/40 (5.00%)  2
Portal hypertension * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Infections and infestations     
Pharyngitis * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Upper respiratory infection * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Urinary tract infection * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Injury, poisoning and procedural complications     
Radiation recall reaction (dermatologic) * 1  0/17 (0.00%)  0 1/40 (2.50%)  2
Investigations     
Activated partial thromboplastin time prolonged * 1  0/17 (0.00%)  0 3/40 (7.50%)  4
Alanine aminotransferase increased * 1  4/17 (23.53%)  6 18/40 (45.00%)  46
Alkaline phosphatase increased * 1  9/17 (52.94%)  15 18/40 (45.00%)  44
Amylase increased * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Aspartate aminotransferase increased * 1  5/17 (29.41%)  8 26/40 (65.00%)  91
Creatinine increased * 1  1/17 (5.88%)  1 5/40 (12.50%)  8
Hyperbilirubinemia * 1  7/17 (41.18%)  9 15/40 (37.50%)  40
INR increased * 1  1/17 (5.88%)  2 4/40 (10.00%)  6
Laboratory test abnormal * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Leukopenia * 1  0/17 (0.00%)  0 5/40 (12.50%)  18
Lipase increased * 1  0/17 (0.00%)  0 2/40 (5.00%)  2
Lymphopenia * 1  2/17 (11.76%)  4 7/40 (17.50%)  13
Neutrophil count decreased * 1  0/17 (0.00%)  0 5/40 (12.50%)  7
Platelet count decreased * 1  0/17 (0.00%)  0 12/40 (30.00%)  42
Weight loss * 1  3/17 (17.65%)  4 7/40 (17.50%)  8
Metabolism and nutrition disorders     
Anorexia * 1  5/17 (29.41%)  11 16/40 (40.00%)  23
Blood bicarbonate decreased * 1  0/17 (0.00%)  0 4/40 (10.00%)  5
Dehydration * 1  2/17 (11.76%)  2 2/40 (5.00%)  2
Hypercalcemia * 1  1/17 (5.88%)  1 0/40 (0.00%)  0
Hyperglycemia * 1  8/17 (47.06%)  17 20/40 (50.00%)  50
Hyperkalemia * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Hypermagnesemia * 1  1/17 (5.88%)  1 0/40 (0.00%)  0
Hypernatremia * 1  1/17 (5.88%)  1 0/40 (0.00%)  0
Hypoalbuminemia * 1  6/17 (35.29%)  8 15/40 (37.50%)  31
Hypocalcemia * 1  2/17 (11.76%)  2 4/40 (10.00%)  8
Hypoglycemia * 1  0/17 (0.00%)  0 2/40 (5.00%)  3
Hypokalemia * 1  4/17 (23.53%)  5 3/40 (7.50%)  7
Hypomagnesemia * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Hyponatremia * 1  4/17 (23.53%)  6 12/40 (30.00%)  20
Hypophosphatemia * 1  1/17 (5.88%)  1 1/40 (2.50%)  1
Musculoskeletal and connective tissue disorders     
Back pain * 1  2/17 (11.76%)  3 4/40 (10.00%)  5
Bone pain * 1  1/17 (5.88%)  3 0/40 (0.00%)  0
Chest wall pain * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Joint pain * 1  1/17 (5.88%)  1 2/40 (5.00%)  4
Muscle weakness * 1  1/17 (5.88%)  1 3/40 (7.50%)  3
Myalgia * 1  1/17 (5.88%)  1 1/40 (2.50%)  3
Neck pain * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Pain in extremity * 1  0/17 (0.00%)  0 2/40 (5.00%)  3
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumor pain * 1  1/17 (5.88%)  2 1/40 (2.50%)  1
Nervous system disorders     
Ataxia * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Dizziness * 1  2/17 (11.76%)  2 2/40 (5.00%)  3
Headache * 1  0/17 (0.00%)  0 5/40 (12.50%)  6
Peripheral motor neuropathy * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Peripheral sensory neuropathy * 1  1/17 (5.88%)  1 1/40 (2.50%)  3
Taste alteration * 1  2/17 (11.76%)  3 6/40 (15.00%)  9
Psychiatric disorders     
Anxiety * 1  0/17 (0.00%)  0 1/40 (2.50%)  2
Confusion * 1  1/17 (5.88%)  2 2/40 (5.00%)  2
Depression * 1  0/17 (0.00%)  0 2/40 (5.00%)  2
Insomnia * 1  0/17 (0.00%)  0 7/40 (17.50%)  10
Renal and urinary disorders     
Kidney pain * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Proteinuria * 1  1/17 (5.88%)  1 0/40 (0.00%)  0
Urinary frequency * 1  0/17 (0.00%)  0 1/40 (2.50%)  2
Reproductive system and breast disorders     
Pelvic pain * 1  1/17 (5.88%)  1 0/40 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough * 1  1/17 (5.88%)  1 3/40 (7.50%)  3
Dyspnea * 1  0/17 (0.00%)  0 3/40 (7.50%)  10
Hemorrhage nasal * 1  1/17 (5.88%)  1 2/40 (5.00%)  2
Hypoxia * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Laryngoscopy abnormal * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Pharyngolaryngeal pain * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Pleural effusion * 1  0/17 (0.00%)  0 1/40 (2.50%)  3
Pleuritic pain * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Pneumonitis * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Skin and subcutaneous tissue disorders     
Acne * 1  2/17 (11.76%)  5 9/40 (22.50%)  24
Alopecia * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Dry skin * 1  1/17 (5.88%)  2 5/40 (12.50%)  10
Hand-and-foot syndrome * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Petechiae * 1  0/17 (0.00%)  0 2/40 (5.00%)  2
Pruritus * 1  2/17 (11.76%)  3 10/40 (25.00%)  16
Rash desquamating * 1  5/17 (29.41%)  5 12/40 (30.00%)  37
Skin disorder * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Skin hyperpigmentation * 1  1/17 (5.88%)  3 3/40 (7.50%)  17
Sweating * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Vascular disorders     
Flushing * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
Hypotension * 1  0/17 (0.00%)  0 1/40 (2.50%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, meddra9.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: DCC Project Administrator
Organization: California Cancer Consortium
Phone: 626-256-4673 ext 60094
EMail: CCCP@coh.org
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00101036     History of Changes
Other Study ID Numbers: NCI-2012-03065
NCI-2012-03065 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
PHII-53 ( Other Identifier: UC Davis Comprehensive Cancer Center )
6674 ( Other Identifier: CTEP )
N01CM62201 ( U.S. NIH Grant/Contract )
N01CM62209 ( U.S. NIH Grant/Contract )
First Submitted: January 7, 2005
First Posted: January 10, 2005
Results First Submitted: July 21, 2014
Results First Posted: January 5, 2015
Last Update Posted: April 20, 2018