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Lapatinib in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy (NRR)

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ClinicalTrials.gov Identifier: NCT00246753
Recruitment Status : Completed
First Posted : October 31, 2005
Results First Posted : June 28, 2017
Last Update Posted : June 28, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Intervention Drug: lapatinib ditosylate
Enrollment 29
Recruitment Details Men with castration-resistant prostate cancer were recruited from 3 local institutions from 11/11/2005 to 8/29/2007.
Pre-assignment Details Of the 35 patients initially recruited, 4 were not eligible. One patient was removed in order to receive more aggressive treatment and another patient was removed due to disease progression or death prior to protocol therapy. 29 patients were enrolled.
Arm/Group Title Single Arm Trial
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Single Arm Trial

lapatinib ditosylate: 1500 mg, daily until disease progression

Period Title: Overall Study
Started 29
Completed 21
Not Completed 8
Reason Not Completed
Withdrawal by Subject             2
Physician Decision             2
Adverse Event             2
Unacceptable toxicity             2
Arm/Group Title Single Arm Trial
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Single Arm Trial

lapatinib ditosylate: 1500 mg, daily until disease progression

Overall Number of Baseline Participants 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 29 participants
72.5
(58 to 90)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
Female
0
   0.0%
Male
29
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
  10.3%
White
26
  89.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 29 participants
29
PSA   [1] 
Median (Full Range)
Unit of measure:  ng/mL
Number Analyzed 29 participants
21.6
(4.5 to 196.5)
[1]
Measure Description: Prostate-specific antigen, or PSA, is a protein produced by cells of the prostate gland. The PSA test measures the level of PSA in an individual's blood.The results are usually reported as nanograms of PSA per (ng/mL) of blood. In this study PSA response is defined as >50% decrease in PSA from baseline for 2 successive measurements at lease 4 weeks apart.
Alkaline phosphatase   [1] 
Median (Full Range)
Unit of measure:  U/L
Number Analyzed 29 participants
85
(55 to 110)
[1]
Measure Description: Alkaline phosphatase (ALP) is an enzyme found in your bloodstream. ALP helps break down proteins in the body and exists in different forms, depending on where it originates. Normal range is 44 to 147 U/L ( units per liter)
Hemoglobin   [1] 
Median (Full Range)
Unit of measure:  Grams per deciliter
Number Analyzed 29 participants
13
(11 to 14.7)
[1]
Measure Description: Hemoglobin is a component of red blood cells. The normal level is around 15 grams per deciliter (g/dl) and lower levels in men with prostate cancer indicate a worse prognosis.
Disease Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
Bone metastases only
8
  27.6%
Measurable disease only
7
  24.1%
Both bone and measureable disease
7
  24.1%
No metastasis
7
  24.1%
[1]
Measure Description: Metastasis is the development of secondary malignant growths at a distance from a primary site of cancer. Measurable disease is the presence of at least one measurable lesion. This is based on RECIST criteria. Response Evaluation Criteria In Solid Tumors (RECIST) is a set of published rules that defines the status of cancer in a patient. Looking at when tumors improve, stay the same, or worsen.
1.Primary Outcome
Title Number of Patients Experiencing Decline in Prostate-specific Antigen
Hide Description Determine the number of patients with hormone-refractory prostate cancer who experience > 50% decline in PSA from baseline for 2 successive measurements at least 4 weeks apart after treatment with lapatinib ditosylate.
Time Frame 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm Trial
Hide Arm/Group Description:

Single Arm Trial

lapatinib ditosylate: 1500 mg, daily until disease progression

Overall Number of Participants Analyzed 21
Measure Type: Count of Participants
Unit of Measure: Participants
2
   9.5%
2.Secondary Outcome
Title Time to Prostate-Specific Antigen (PSA) Progression
Hide Description Measured from start date of treatment to date of PSA progression, defined as a 25% increase above the pretreatment value or the nadir PSA (whichever is lower) and a minimum increase of 5 ng/ml, confirmed 2 or more weeks later.
Time Frame 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm Trial
Hide Arm/Group Description:

Single Arm Trial

lapatinib ditosylate: 1500 mg, daily until disease progression

Overall Number of Participants Analyzed 21
Median (95% Confidence Interval)
Unit of Measure: days
29
(29 to 56)
3.Secondary Outcome
Title Predictive Molecular Markers of Response to Treatment With Lapatinib (GW572016)
Hide Description To assess the correlation between expression of molecular markers and patient response to treatment with GW572016
Time Frame 4 years
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Hide Analysis Population Description
Data were not collected.
Arm/Group Title Single Arm Trial
Hide Arm/Group Description:

Single Arm Trial

lapatinib ditosylate: 1500 mg, daily until disease progression

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 4 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Arm Trial
Hide Arm/Group Description

Single Arm Trial

lapatinib ditosylate: 1500 mg, daily until disease progression

All-Cause Mortality
Single Arm Trial
Affected / at Risk (%)
Total   0/29 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Single Arm Trial
Affected / at Risk (%)
Total   4/29 (13.79%) 
Cardiac disorders   
Cardiac ischemia/infarction * 1  1/29 (3.45%) 
Gastrointestinal disorders   
Epigastric pain * 1  1/29 (3.45%) 
Diarrhea * 1  1/29 (3.45%) 
Injury, poisoning and procedural complications   
Fracture * 1  1/29 (3.45%) 
Musculoskeletal and connective tissue disorders   
Pain - Back * 1  1/29 (3.45%) 
Renal and urinary disorders   
Renal failure * 1  1/29 (3.45%) 
1
Term from vocabulary, CTCAE (3.0)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Single Arm Trial
Affected / at Risk (%)
Total   29/29 (100.00%) 
Blood and lymphatic system disorders   
Elevated Phosphorus * 1  1/29 (3.45%) 
Hemoglobin * 1  12/29 (41.38%) 
Neutrophils/granulocytes (ANC/AGC) * 1  1/29 (3.45%) 
Cardiac disorders   
Hypertension * 1  2/29 (6.90%) 
Pain - Cardiac/heart * 1  1/29 (3.45%) 
Ear and labyrinth disorders   
Hearing loss * 1  1/29 (3.45%) 
Endocrine disorders   
Thyroid function, low (hypothyroidism) * 1  1/29 (3.45%) 
Eye disorders   
Dry eye syndrome * 1  1/29 (3.45%) 
Conjunctivitis * 1  1/29 (3.45%) 
Gastrointestinal disorders   
Anorexia * 1  9/29 (31.03%) 
Constipation * 1  5/29 (17.24%) 
Dehydration * 1  1/29 (3.45%) 
Diarrhea * 1  22/29 (75.86%) 
Distension/bloating, abdominal * 1  1/29 (3.45%) 
Dry mouth/salivary gland (xerostomia) * 1  2/29 (6.90%) 
Dysphagia (difficulty swallowing) * 1  1/29 (3.45%) 
Flatulence * 1  4/29 (13.79%) 
Epigastric pain * 1  1/29 (3.45%) 
Heartburn/dyspepsia * 1  8/29 (27.59%) 
Mucositis/stomatitis (clinical exam) - Anus * 1  1/29 (3.45%) 
Mucositis/stomatitis (clinical exam) - Oral cavity * 1  2/29 (6.90%) 
Nausea * 1  8/29 (27.59%) 
Pain - Abdomen NOS * 1  1/29 (3.45%) 
Pain-Stomach * 1  1/29 (3.45%) 
Vomiting * 1  5/29 (17.24%) 
Large stools * 1  1/29 (3.45%) 
General disorders   
Edema: limb * 1  5/29 (17.24%) 
Fatigue (asthenia, lethargy, malaise) * 1  21/29 (72.41%) 
Flu-like syndrome * 1  4/29 (13.79%) 
Pain - Chest wall * 1  2/29 (6.90%) 
Shoulder Pain * 1  3/29 (10.34%) 
Pain - Pain NOS * 1  1/29 (3.45%) 
Rigors/chills * 1  2/29 (6.90%) 
Heel pain * 1  3/29 (10.34%) 
Immune system disorders   
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) * 1  2/29 (6.90%) 
Infections and infestations   
Infection with normal ANC or Grade 1 or 2 neutrophils - Appendix * 1  1/29 (3.45%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia) * 1  1/29 (3.45%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Upper airway NOS * 1  2/29 (6.90%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS * 1  3/29 (10.34%) 
Investigations   
Creatinine * 1  3/29 (10.34%) 
Leukocytes (total WBC) * 1  1/29 (3.45%) 
Lymphopenia * 1  6/29 (20.69%) 
Weight loss * 1  3/29 (10.34%) 
Metabolism and nutrition disorders   
Albumin, serum-low (hypoalbuminemia) * 1  2/29 (6.90%) 
Alkaline phosphatase * 1  1/29 (3.45%) 
ALT, SGPT (serum glutamic pyruvic transaminase) * 1  3/29 (10.34%) 
AST, SGOT(serum glutamic oxaloacetic transaminase) * 1  1/29 (3.45%) 
Bilirubin (hyperbilirubinemia) * 1  1/29 (3.45%) 
Cholesterol, serum-high (hypercholesteremia) * 1  1/29 (3.45%) 
Glucose, serum-high (hyperglycemia) * 1  2/29 (6.90%) 
Magnesium, serum-high (hypermagnesemia) * 1  5/29 (17.24%) 
Potassium, serum-high (hyperkalemia) * 1  3/29 (10.34%) 
Sodium, serum-low (hyponatremia) * 1  1/29 (3.45%) 
Musculoskeletal and connective tissue disorders   
Joint-function * 1  1/29 (3.45%) 
Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-lower * 1  1/29 (3.45%) 
Muscle weakness, generalized or specific area (not due to neuropathy) - Right-sided * 1  1/29 (3.45%) 
Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized * 1  1/29 (3.45%) 
Pain - Back * 1  3/29 (10.34%) 
Pain - Extremity-limb * 1  3/29 (10.34%) 
Pain - Joint * 1  5/29 (17.24%) 
Pain - Muscle * 1  1/29 (3.45%) 
Nervous system disorders   
Dizziness * 1  2/29 (6.90%) 
Memory impairment * 1  2/29 (6.90%) 
Neuropathy: sensory * 1  1/29 (3.45%) 
Pain - Head/headache * 1  5/29 (17.24%) 
Taste alteration (dysgeusia) * 1  2/29 (6.90%) 
Tremor * 1  2/29 (6.90%) 
Psychiatric disorders   
Insomnia * 1  3/29 (10.34%) 
Renal and urinary disorders   
Bladder spasms * 1  2/29 (6.90%) 
Hemorrhage, GU - Bladder * 1  1/29 (3.45%) 
Incontinence, urinary * 1  1/29 (3.45%) 
Leak (including anastomotic), GU - Bladder * 1  1/29 (3.45%) 
Obstruction, GU - Bladder * 1  1/29 (3.45%) 
Lower urinary tract symptoms * 1  1/29 (3.45%) 
Urinary frequency/urgency * 1  5/29 (17.24%) 
Dysuria * 1  1/29 (3.45%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath) * 1  1/29 (3.45%) 
Hemorrhage, pulmonary/upper respiratory - Nose * 1  1/29 (3.45%) 
Nasal cavity/paranasal sinus reactions * 1  1/29 (3.45%) 
Upper respiratory infection * 1  1/29 (3.45%) 
Skin and subcutaneous tissue disorders   
Skin lesions * 1  1/29 (3.45%) 
Dry skin * 1  4/29 (13.79%) 
Hair loss/alopecia (scalp or body) * 1  1/29 (3.45%) 
Nail changes * 1  3/29 (10.34%) 
Pruritus/itching * 1  4/29 (13.79%) 
Rash/desquamation * 1  4/29 (13.79%) 
Rash: acne/acneiform * 1  7/29 (24.14%) 
Rash: hand-foot skin reaction * 1  3/29 (10.34%) 
Skin breakdown/decubitus ulcer * 1  1/29 (3.45%) 
Sweating (diaphoresis) * 1  1/29 (3.45%) 
Urticaria (hives, welts, wheals) * 1  1/29 (3.45%) 
Oily skin * 1  1/29 (3.45%) 
Bleeding mole * 1  1/29 (3.45%) 
Vascular disorders   
Gross hematuria * 1 [1]  1/29 (3.45%) 
Hot flashes/flushes * 1  1/29 (3.45%) 
1
Term from vocabulary, CTCAE (3.0)
*
Indicates events were collected by non-systematic assessment
[1]
1 x daily
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: Robin V. Johnson
Organization: UNC Lineberger Comprehensive Cancer Center
Phone: 919-966-1125
Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00246753     History of Changes
Other Study ID Numbers: LCCC 0505
CDR0000550151 ( Other Identifier: PDQ number )
First Submitted: October 28, 2005
First Posted: October 31, 2005
Results First Submitted: March 8, 2017
Results First Posted: June 28, 2017
Last Update Posted: June 28, 2017