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Lapatinib in Treating Patients With Recurrent and/or Metastatic Adenoid Cystic Cancer or Other Salivary Gland Cancers

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ClinicalTrials.gov Identifier: NCT00095563
Recruitment Status : Completed
First Posted : November 8, 2004
Results First Posted : April 18, 2017
Last Update Posted : April 18, 2017
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 High-grade Salivary Gland Carcinoma
High-grade Salivary Gland Mucoepidermoid Carcinoma
Low-grade Salivary Gland Carcinoma
Low-grade Salivary Gland Mucoepidermoid Carcinoma
Recurrent Adenoid Cystic Carcinoma of the Oral Cavity
Recurrent Salivary Gland Cancer
Salivary Gland Acinic Cell Tumor
Salivary Gland Adenocarcinoma
Salivary Gland Adenoid Cystic Carcinoma
Salivary Gland Malignant Mixed Cell Type Tumor
Interventions Drug: lapatinib ditosylate
Other: laboratory biomarker analysis
Enrollment 40
Recruitment Details  
Pre-assignment Details 1 enrolled patient was a screen failure.
Arm/Group Title Treatment (Lapatinib Ditosylate)
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Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.

lapatinib ditosylate: Given orally

laboratory biomarker analysis: Correlative studies

Period Title: Overall Study
Started 39
Completed 39
Not Completed 0
Arm/Group Title Treatment (Lapatinib Ditosylate)
Hide Arm/Group Description

Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.

lapatinib ditosylate: Given orally

laboratory biomarker analysis: Correlative studies

Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
<=18 years
0
   0.0%
Between 18 and 65 years
27
  67.5%
>=65 years
13
  32.5%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 40 participants
57
(39 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
11
  27.5%
Male
29
  72.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 40 participants
40
1.Primary Outcome
Title Objective Response Rates (Partial and Complete Responses)
Hide Description Per Response - Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions;
Time Frame Up to 5 years
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Hide Analysis Population Description
36 assessable participants.
Arm/Group Title Treatment (Lapatinib Ditosylate)
Hide Arm/Group Description:

Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.

lapatinib ditosylate: Given orally

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 36
Measure Type: Number
Unit of Measure: participants
0
2.Secondary Outcome
Title Duration of Objective Response
Hide Description [Not Specified]
Time Frame From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years
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Hide Analysis Population Description
This assessment was not performed since no participants showed a response.
Arm/Group Title Treatment (Lapatinib Ditosylate)
Hide Arm/Group Description:

Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.

lapatinib ditosylate: Given orally

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Rate of Stable Disease
Hide Description Number of patients who had Stable disease for more than or equal to 6 months together in both Adenoid cystic carcinoma (ACC) and non-adenoid cyctic carcinoma (non-ACC)
Time Frame 6 months
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Hide Analysis Population Description
36 assessable participants, 19 with ACC and 17 with non-ACC.
Arm/Group Title Treatment (Lapatinib Ditosylate)
Hide Arm/Group Description:

Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.

lapatinib ditosylate: Given orally

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 36
Measure Type: Number
Unit of Measure: participants
ACC Number Analyzed 19 participants
9
Non-ACC Number Analyzed 17 participants
4
4.Secondary Outcome
Title Progression-free Survival (PFS) According to RECIST
Hide Description [Not Specified]
Time Frame From the date of study enrolment to disease progression, death or last contact, or last tumor assessment before the start of further anti-tumor therapy, assessed up to 5 years
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Hide Analysis Population Description
36 assessable participants, 19 with ACC and 17 with non-ACC.
Arm/Group Title Treatment (Lapatinib Ditosylate)
Hide Arm/Group Description:

Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.

lapatinib ditosylate: Given orally

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 36
Median (95% Confidence Interval)
Unit of Measure: months
ACC Number Analyzed 19 participants
3.6
(3.1 to 12.4)
Non-ACC Number Analyzed 17 participants
2.1
(1.6 to 9.2)
5.Secondary Outcome
Title Overall Survival (OS)
Hide Description Survival estimates will be computed using the Kaplan-Meier method.
Time Frame From the date of study enrolment to death or last contact, assessed up to 5 years
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Hide Analysis Population Description
20 participants with ACC, 19 participants with non-ACC.
Arm/Group Title Treatment (Lapatinib Ditosylate)
Hide Arm/Group Description:

Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.

lapatinib ditosylate: Given orally

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 39
Median (95% Confidence Interval)
Unit of Measure: months
ACC Number Analyzed 20 participants
NA [1] 
(NA to NA)
Non-ACC Number Analyzed 19 participants
16.5
(9.1 to 30.9)
[1]
Not reached
6.Secondary Outcome
Title Most Frequent Adverse Events of Grade 1-2 by CTCAE Grading
Hide Description Number of participants that experienced the most frequent adverse events of grade 1-2 by CTCAE grading.
Time Frame Up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Lapatinib Ditosylate)
Hide Arm/Group Description:

Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.

lapatinib ditosylate: Given orally

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 39
Measure Type: Number
Unit of Measure: participants
Diarrhea 26
Fatigue 28
Rash 19
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Lapatinib Ditosylate)
Hide Arm/Group Description

Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.

lapatinib ditosylate: Given orally

laboratory biomarker analysis: Correlative studies

All-Cause Mortality
Treatment (Lapatinib Ditosylate)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Lapatinib Ditosylate)
Affected / at Risk (%)
Total   6/39 (15.38%) 
Ear and labyrinth disorders   
Hearing loss   1/39 (2.56%) 
Injury, poisoning and procedural complications   
Fracture   1/39 (2.56%) 
Investigations   
Weight gain   1/39 (2.56%) 
Renal and urinary disorders   
Ureteric obstruction   1/39 (2.56%) 
Respiratory, thoracic and mediastinal disorders   
Laryngeal edema   1/39 (2.56%) 
Voice alteration   1/39 (2.56%) 
Dyspnea   2/39 (5.13%) 
Pneumonitis   1/39 (2.56%) 
Vascular disorders   
Hypertension   1/39 (2.56%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Treatment (Lapatinib Ditosylate)
Affected / at Risk (%)
Total   39/39 (100.00%) 
Blood and lymphatic system disorders   
Leukocyte count decreased   11/39 (28.21%) 
Cardiac disorders   
Left ventricular failure   1/39 (2.56%) 
Sinus bradycardia   2/39 (5.13%) 
Sinus tachycardia   1/39 (2.56%) 
Ear and labyrinth disorders   
External ear inflammation   2/39 (5.13%) 
Hearing loss   4/39 (10.26%) 
Otitis externa   1/39 (2.56%) 
Tinnitus   1/39 (2.56%) 
Eye disorders   
Diplopia   1/39 (2.56%) 
Dry eye syndrome   1/39 (2.56%) 
Eye pain   1/39 (2.56%) 
Loss Of Peripheral Vision   1/39 (2.56%) 
Vision blurred   2/39 (5.13%) 
Vision Changes   1/39 (2.56%) 
Watering eyes   1/39 (2.56%) 
Gastrointestinal disorders   
Abdominal distension   2/39 (5.13%) 
Abdominal pain   4/39 (10.26%) 
Cheilitis   2/39 (5.13%) 
Constipation   7/39 (17.95%) 
Diarrhea   26/39 (66.67%) 
Dry lips   1/39 (2.56%) 
Dry mouth   3/39 (7.69%) 
Dyspepsia   11/39 (28.21%) 
Dysphagia   6/39 (15.38%) 
Early Satiety   1/39 (2.56%) 
Mucositis oral   8/39 (20.51%) 
Nausea   16/39 (41.03%) 
Oral pain   1/39 (2.56%) 
Salivation   1/39 (2.56%) 
Toothache   2/39 (5.13%) 
Ulceration - medical intervention not indicated   1/39 (2.56%) 
Vomiting   6/39 (15.38%) 
General disorders   
Chest pain   6/39 (15.38%) 
Chest wall pain   2/39 (5.13%) 
Ear, nose and throat examination abnormal   4/39 (10.26%) 
Edema limbs   5/39 (12.82%) 
Facial pain   3/39 (7.69%) 
Fatigue   28/39 (71.79%) 
Fever   2/39 (5.13%) 
Flu-like symptoms   1/39 (2.56%) 
Localized edema   1/39 (2.56%) 
Infections and infestations   
Eye infection   2/39 (5.13%) 
Kidney infection   1/39 (2.56%) 
Left Ear Drainage   1/39 (2.56%) 
Mucosal infection   1/39 (2.56%) 
Nail infection   3/39 (7.69%) 
Pain   1/39 (2.56%) 
Plantar Wart   1/39 (2.56%) 
Sinusitis   1/39 (2.56%) 
Tooth infection   1/39 (2.56%) 
Upper aerodigestive tract infection   1/39 (2.56%) 
Upper respiratory infection   3/39 (7.69%) 
Injury, poisoning and procedural complications   
Dermatitis radiation   1/39 (2.56%) 
Knee injury   1/39 (2.56%) 
Thermal burn   1/39 (2.56%) 
Investigations   
Activated partial thromboplastin time prolonged   4/39 (10.26%) 
Alanine aminotransferase increased   8/39 (20.51%) 
Alkaline phosphatase increased   12/39 (30.77%) 
Aspartate aminotransferase increased   12/39 (30.77%) 
Bilirubin increased   6/39 (15.38%) 
Coagulopathy - PT   1/39 (2.56%) 
Creatinine increased   4/39 (10.26%) 
Gamma-glutamyltransferase increased   1/39 (2.56%) 
Hemoglobin decreased   20/39 (51.28%) 
INR increased   1/39 (2.56%) 
Lymphocyte count decreased   25/39 (64.10%) 
Neutrophil count decreased   7/39 (17.95%) 
Platelet count decreased   2/39 (5.13%) 
Serum cholesterol increased   2/39 (5.13%) 
Weight gain   1/39 (2.56%) 
Weight loss   3/39 (7.69%) 
Metabolism and nutrition disorders   
Anorexia   10/39 (25.64%) 
Blood glucose increased   16/39 (41.03%) 
Blood uric acid increased   2/39 (5.13%) 
Dehydration   1/39 (2.56%) 
Serum albumin decreased   3/39 (7.69%) 
Serum calcium decreased   3/39 (7.69%) 
Serum calcium increased   5/39 (12.82%) 
Serum glucose decreased   1/39 (2.56%) 
Serum magnesium decreased   2/39 (5.13%) 
Serum phosphate decreased   7/39 (17.95%) 
Serum potassium decreased   5/39 (12.82%) 
Serum potassium increased   1/39 (2.56%) 
Serum sodium decreased   5/39 (12.82%) 
Serum sodium increased   2/39 (5.13%) 
Musculoskeletal and connective tissue disorders   
Arthritis   1/39 (2.56%) 
Back pain   7/39 (17.95%) 
Bone pain   4/39 (10.26%) 
Joint pain   3/39 (7.69%) 
Myalgia   4/39 (10.26%) 
Neck pain   5/39 (12.82%) 
Neck soft tissue necrosis   1/39 (2.56%) 
Pain - hands   1/39 (2.56%) 
Pain - hip   2/39 (5.13%) 
Pain - jaw   1/39 (2.56%) 
Pain - left jaw   1/39 (2.56%) 
Trismus   1/39 (2.56%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Cyst on back   1/39 (2.56%) 
Second Malignancy, Supraglottic Cancer   1/39 (2.56%) 
Tumor pain   1/39 (2.56%) 
Nervous system disorders   
Ataxia   1/39 (2.56%) 
Burning in feet   1/39 (2.56%) 
Dizziness   4/39 (10.26%) 
Facial nerve disorder   1/39 (2.56%) 
Headache   10/39 (25.64%) 
Neuralgia   2/39 (5.13%) 
Nystagmus   1/39 (2.56%) 
Optic nerve disorder   1/39 (2.56%) 
Peripheral motor neuropathy   2/39 (5.13%) 
Peripheral sensory neuropathy   12/39 (30.77%) 
Pyramidal tract syndrome   1/39 (2.56%) 
Speech disorder   1/39 (2.56%) 
Taste alteration   6/39 (15.38%) 
Tremor   2/39 (5.13%) 
Trigeminal nerve disorder   1/39 (2.56%) 
Psychiatric disorders   
Anxiety   4/39 (10.26%) 
Depression   3/39 (7.69%) 
Insomnia   11/39 (28.21%) 
Renal and urinary disorders   
Dysuria   2/39 (5.13%) 
Ureteric obstruction   1/39 (2.56%) 
Urinary frequency   3/39 (7.69%) 
Urinary incontinence   1/39 (2.56%) 
Urinary tract infection   2/39 (5.13%) 
Reproductive system and breast disorders   
Erectile dysfunction   1/39 (2.56%) 
Menopausal symptoms   1/39 (2.56%) 
Vaginal discharge   1/39 (2.56%) 
Vaginal dryness   1/39 (2.56%) 
Vaginal hemorrhage   1/39 (2.56%) 
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis   5/39 (12.82%) 
Bronchopulmonary hemorrhage   1/39 (2.56%) 
Cough   14/39 (35.90%) 
Dyspnea   18/39 (46.15%) 
Hemorrhage nasal   5/39 (12.82%) 
Hiccups   2/39 (5.13%) 
Laryngitis   1/39 (2.56%) 
Nasal congestion   4/39 (10.26%) 
Pharyngolaryngeal pain   1/39 (2.56%) 
Pulmonary hemorrhage   1/39 (2.56%) 
Voice alteration   4/39 (10.26%) 
Skin and subcutaneous tissue disorders   
Alopecia   4/39 (10.26%) 
Dry skin   12/39 (30.77%) 
Folliculitis   1/39 (2.56%) 
Nail disorder   3/39 (7.69%) 
Onycolysis   1/39 (2.56%) 
Pruritus   7/39 (17.95%) 
Rash acneiform   19/39 (48.72%) 
Rash desquamating   5/39 (12.82%) 
Skin change   1/39 (2.56%) 
Skin hyperpigmentation   1/39 (2.56%) 
Skin ulceration   1/39 (2.56%) 
Skin-Carbuncle   1/39 (2.56%) 
Thinner Skin Finger Tips   1/39 (2.56%) 
Urticaria   1/39 (2.56%) 
Vascular disorders   
Flushing   1/39 (2.56%) 
Indicates events were collected by systematic assessment
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: Dr. Lillian Siu
Organization: Princess Margaret Cancer Centre
Phone: 416-946-2911
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00095563     History of Changes
Other Study ID Numbers: NCI-2012-03089
NCI-2012-03089 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
6701
PHL-028 ( Other Identifier: Princess Margaret Hospital Phase 2 Consortium )
6701 ( Other Identifier: CTEP )
N01CM62201 ( U.S. NIH Grant/Contract )
N01CM62203 ( U.S. NIH Grant/Contract )
First Submitted: November 5, 2004
First Posted: November 8, 2004
Results First Submitted: July 30, 2015
Results First Posted: April 18, 2017
Last Update Posted: April 18, 2017