Trial Outcomes & Findings for Lapatinib in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy (NCT NCT00246753)
NCT ID: NCT00246753
Last Updated: 2017-06-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
4 years
Results posted on
2017-06-28
Participant Flow
Men with castration-resistant prostate cancer were recruited from 3 local institutions from 11/11/2005 to 8/29/2007.
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.
Participant milestones
| Measure |
Single Arm Trial
Single Arm Trial
lapatinib ditosylate: 1500 mg, daily until disease progression
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Single Arm Trial
Single Arm Trial
lapatinib ditosylate: 1500 mg, daily until disease progression
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Unacceptable toxicity
|
2
|
Baseline Characteristics
Lapatinib in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy
Baseline characteristics by cohort
| Measure |
Single Arm Trial
n=29 Participants
Single Arm Trial
lapatinib ditosylate: 1500 mg, daily until disease progression
|
|---|---|
|
Age, Continuous
|
72.5 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=99 Participants
|
|
PSA
|
21.6 ng/mL
n=99 Participants
|
|
Alkaline phosphatase
|
85 U/L
n=99 Participants
|
|
Hemoglobin
|
13 grams per deciliter
n=99 Participants
|
|
Disease Status
Bone metastases only
|
8 Participants
n=99 Participants
|
|
Disease Status
Measurable disease only
|
7 Participants
n=99 Participants
|
|
Disease Status
Both bone and measureable disease
|
7 Participants
n=99 Participants
|
|
Disease Status
No metastasis
|
7 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 4 yearsDetermine 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.
Outcome measures
| Measure |
Single Arm Trial
n=21 Participants
Single Arm Trial
lapatinib ditosylate: 1500 mg, daily until disease progression
|
|---|---|
|
Number of Patients Experiencing Decline in Prostate-specific Antigen
|
2 Participants
|
SECONDARY outcome
Timeframe: 4 yearsMeasured 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.
Outcome measures
| Measure |
Single Arm Trial
n=21 Participants
Single Arm Trial
lapatinib ditosylate: 1500 mg, daily until disease progression
|
|---|---|
|
Time to Prostate-Specific Antigen (PSA) Progression
|
29 days
Interval 29.0 to 56.0
|
SECONDARY outcome
Timeframe: 4 yearsPopulation: Data were not collected.
To assess the correlation between expression of molecular markers and patient response to treatment with GW572016
Outcome measures
Outcome data not reported
Adverse Events
Single Arm Trial
Serious events: 4 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single Arm Trial
n=29 participants at risk
Single Arm Trial
lapatinib ditosylate: 1500 mg, daily until disease progression
|
|---|---|
|
Gastrointestinal disorders
Epigastric pain
|
3.4%
1/29 • 4 years
|
|
Gastrointestinal disorders
Diarrhea
|
3.4%
1/29 • 4 years
|
|
Renal and urinary disorders
Renal failure
|
3.4%
1/29 • 4 years
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
3.4%
1/29 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
3.4%
1/29 • 4 years
|
|
Injury, poisoning and procedural complications
Fracture
|
3.4%
1/29 • 4 years
|
Other adverse events
| Measure |
Single Arm Trial
n=29 participants at risk
Single Arm Trial
lapatinib ditosylate: 1500 mg, daily until disease progression
|
|---|---|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
6.9%
2/29 • 4 years
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
3.4%
1/29 • 4 years
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
6.9%
2/29 • 4 years
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
10.3%
3/29 • 4 years
|
|
Gastrointestinal disorders
Anorexia
|
31.0%
9/29 • 4 years
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
3.4%
1/29 • 4 years
|
|
Ear and labyrinth disorders
Hearing loss
|
3.4%
1/29 • 4 years
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
3.4%
1/29 • 4 years
|
|
Renal and urinary disorders
Bladder spasms
|
6.9%
2/29 • 4 years
|
|
Blood and lymphatic system disorders
Elevated Phosphorus
|
3.4%
1/29 • 4 years
|
|
Metabolism and nutrition disorders
Cholesterol, serum-high (hypercholesteremia)
|
3.4%
1/29 • 4 years
|
|
Gastrointestinal disorders
Constipation
|
17.2%
5/29 • 4 years
|
|
Investigations
Creatinine
|
10.3%
3/29 • 4 years
|
|
Gastrointestinal disorders
Dehydration
|
3.4%
1/29 • 4 years
|
|
Skin and subcutaneous tissue disorders
Skin lesions
|
3.4%
1/29 • 4 years
|
|
Gastrointestinal disorders
Diarrhea
|
75.9%
22/29 • 4 years
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
3.4%
1/29 • 4 years
|
|
Nervous system disorders
Dizziness
|
6.9%
2/29 • 4 years
|
|
Eye disorders
Dry eye syndrome
|
3.4%
1/29 • 4 years
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
6.9%
2/29 • 4 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
13.8%
4/29 • 4 years
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
3.4%
1/29 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
3.4%
1/29 • 4 years
|
|
General disorders
Edema: limb
|
17.2%
5/29 • 4 years
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
72.4%
21/29 • 4 years
|
|
Gastrointestinal disorders
Flatulence
|
13.8%
4/29 • 4 years
|
|
General disorders
Flu-like syndrome
|
13.8%
4/29 • 4 years
|
|
Gastrointestinal disorders
Epigastric pain
|
3.4%
1/29 • 4 years
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
6.9%
2/29 • 4 years
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
3.4%
1/29 • 4 years
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
27.6%
8/29 • 4 years
|
|
Blood and lymphatic system disorders
Hemoglobin
|
41.4%
12/29 • 4 years
|
|
Renal and urinary disorders
Hemorrhage, GU - Bladder
|
3.4%
1/29 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Nose
|
3.4%
1/29 • 4 years
|
|
Vascular disorders
Gross hematuria
|
3.4%
1/29 • 4 years
|
|
Vascular disorders
Hot flashes/flushes
|
3.4%
1/29 • 4 years
|
|
Cardiac disorders
Hypertension
|
6.9%
2/29 • 4 years
|
|
Renal and urinary disorders
Incontinence, urinary
|
3.4%
1/29 • 4 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Appendix
|
3.4%
1/29 • 4 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)
|
3.4%
1/29 • 4 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Upper airway NOS
|
6.9%
2/29 • 4 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS
|
10.3%
3/29 • 4 years
|
|
Psychiatric disorders
Insomnia
|
10.3%
3/29 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Joint-function
|
3.4%
1/29 • 4 years
|
|
Renal and urinary disorders
Leak (including anastomotic), GU - Bladder
|
3.4%
1/29 • 4 years
|
|
Investigations
Leukocytes (total WBC)
|
3.4%
1/29 • 4 years
|
|
Investigations
Lymphopenia
|
20.7%
6/29 • 4 years
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
17.2%
5/29 • 4 years
|
|
Nervous system disorders
Memory impairment
|
6.9%
2/29 • 4 years
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Anus
|
3.4%
1/29 • 4 years
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
6.9%
2/29 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-lower
|
3.4%
1/29 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Right-sided
|
3.4%
1/29 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized
|
3.4%
1/29 • 4 years
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
10.3%
3/29 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reactions
|
3.4%
1/29 • 4 years
|
|
Gastrointestinal disorders
Nausea
|
27.6%
8/29 • 4 years
|
|
Nervous system disorders
Neuropathy: sensory
|
3.4%
1/29 • 4 years
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
3.4%
1/29 • 4 years
|
|
Renal and urinary disorders
Obstruction, GU - Bladder
|
3.4%
1/29 • 4 years
|
|
Eye disorders
Conjunctivitis
|
3.4%
1/29 • 4 years
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
3.4%
1/29 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
10.3%
3/29 • 4 years
|
|
Cardiac disorders
Pain - Cardiac/heart
|
3.4%
1/29 • 4 years
|
|
General disorders
Pain - Chest wall
|
6.9%
2/29 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
10.3%
3/29 • 4 years
|
|
Nervous system disorders
Pain - Head/headache
|
17.2%
5/29 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
17.2%
5/29 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
3.4%
1/29 • 4 years
|
|
General disorders
Shoulder Pain
|
10.3%
3/29 • 4 years
|
|
General disorders
Pain - Pain NOS
|
3.4%
1/29 • 4 years
|
|
Gastrointestinal disorders
Pain-Stomach
|
3.4%
1/29 • 4 years
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
10.3%
3/29 • 4 years
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
13.8%
4/29 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
3.4%
1/29 • 4 years
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
13.8%
4/29 • 4 years
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
24.1%
7/29 • 4 years
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
10.3%
3/29 • 4 years
|
|
Renal and urinary disorders
Lower urinary tract symptoms
|
3.4%
1/29 • 4 years
|
|
General disorders
Rigors/chills
|
6.9%
2/29 • 4 years
|
|
Skin and subcutaneous tissue disorders
Skin breakdown/decubitus ulcer
|
3.4%
1/29 • 4 years
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
3.4%
1/29 • 4 years
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
3.4%
1/29 • 4 years
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
6.9%
2/29 • 4 years
|
|
Endocrine disorders
Thyroid function, low (hypothyroidism)
|
3.4%
1/29 • 4 years
|
|
Nervous system disorders
Tremor
|
6.9%
2/29 • 4 years
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
17.2%
5/29 • 4 years
|
|
Skin and subcutaneous tissue disorders
Urticaria (hives, welts, wheals)
|
3.4%
1/29 • 4 years
|
|
Gastrointestinal disorders
Vomiting
|
17.2%
5/29 • 4 years
|
|
Investigations
Weight loss
|
10.3%
3/29 • 4 years
|
|
Skin and subcutaneous tissue disorders
Oily skin
|
3.4%
1/29 • 4 years
|
|
Skin and subcutaneous tissue disorders
Bleeding mole
|
3.4%
1/29 • 4 years
|
|
General disorders
Heel pain
|
10.3%
3/29 • 4 years
|
|
Renal and urinary disorders
Dysuria
|
3.4%
1/29 • 4 years
|
|
Gastrointestinal disorders
Large stools
|
3.4%
1/29 • 4 years
|
Additional Information
Robin V. Johnson
UNC Lineberger Comprehensive Cancer Center
Phone: 919-966-1125
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60