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Trial record 29 of 125 for:    lapatinib | Recruiting, Active, not recruiting, Completed Studies | Phase 2

Lapatinib Ditosylate in Treating Patients With a Rising PSA Indicating Recurrent Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00103194
Recruitment Status : Completed
First Posted : February 8, 2005
Results First Posted : April 13, 2012
Last Update Posted : September 30, 2014
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 Recurrent Prostate Cancer
Stage I Prostate Cancer
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Stage III Prostate Cancer
Interventions Drug: lapatinib ditosylate
Other: laboratory biomarker analysis
Enrollment 49
Recruitment Details Participants were recruited from ECOG member institutions between September 29, 2005 and July 5, 2006.
Pre-assignment Details  
Arm/Group Title GW572016 (Lapatinib)
Hide Arm/Group Description GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
Period Title: Overall Study
Started 49
Treated 49
Eligible 35
Eligible and Treated 35
Completed 18
Not Completed 31
Arm/Group Title GW572016 (Lapatinib)
Hide Arm/Group Description GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
Overall Number of Baseline Participants 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Median (Full Range)
Unit of measure:  Years
Number Analyzed 35 participants
65
(48 to 81)
[1]
Measure Description: Age of eligible patients who began treatment.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
Female
0
   0.0%
Male
35
 100.0%
[1]
Measure Description: Gender of eligible patients who began treatment.
1.Primary Outcome
Title Number of Patients With PSA Response, Defined as a 50% or Greater Decline in the Serum PSA Level
Hide Description

PSA response is defined as either complete response (CR) or partial response (PR) observed at any time during the entire measurement time period.

CR: In patients treated with prior radical prostatectomy, a PSA < 0.2 ng/mL confirmed by a repeat PSA at least one month apart was considered a complete biochemical response. In patients treated with radiation therapy only, a PSA < 1 ng/mL on three separate occasions taken at least one month apart was considered a complete biochemical response.

PR: A reduction in PSA by > 50% from baseline, confirmed by repeat PSA 1 month later.

Time Frame Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started protocol treatment
Arm/Group Title GW572016 (Lapatinib)
Hide Arm/Group Description:
GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: participants
Response 0
Stable Disease 28
Progression 4
Unevaluable 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GW572016 (Lapatinib)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter PSA response rate
Estimated Value 0
Confidence Interval (2-Sided) 90%
0 to 8.2
Estimation Comments [Not Specified]
2.Secondary Outcome
Title The Change in PSA Slope With GW572016 (Lapatinib)
Hide Description PSA was evaluated every cycle while on treatment. PSA test results show the level of PSA detected in the blood. These results were reported as nanograms of PSA per milliliter (ng/mL) of blood. PSA slope is the change in PSA level over time. A sharp rise in the PSA level raises the suspicion of cancer and may indicate a fast-growing cancer.
Time Frame Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually, for 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
One patient who withdrew from study after receiving 4 days of treatment and did not have any follow-up PSA measurements was excluded from this analysis, so the number of participants analyzed is 34.
Arm/Group Title GW572016 (Lapatinib)
Hide Arm/Group Description:
GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
Overall Number of Participants Analyzed 34
Mean (Standard Error)
Unit of Measure: log (PSA)/month
Pre-treatment PSA slope 0.19  (0.019)
Post-treatment PSA slope 0.13  (0.017)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GW572016 (Lapatinib)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method Mixed Models Analysis
Comments The analysis is testing the null hypothesis that there is no difference between the pre-treatment and post-treatment PSA slopes.
3.Secondary Outcome
Title Progression-free Survival Rate at 2 Years
Hide Description Proportion of patients who are living with a disease that does not get worse at 2 years from registration based on Kaplan-Meier method.
Time Frame Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started treatment.
Arm/Group Title GW572016 (Lapatinib)
Hide Arm/Group Description:
GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
Overall Number of Participants Analyzed 35
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
16.0
(6.5 to 29.1)
4.Secondary Outcome
Title Relationship Between Progression-free Survival and EGFR Expression Levels
Hide Description The association between EGFR (epidermal growth factor receptor) expression levels and the length of time during and after treatment in which a patient is living with a disease that does not get worse.
Time Frame Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started treatment.
Arm/Group Title GW572016 (Lapatinib)
Hide Arm/Group Description:
GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
Overall Number of Participants Analyzed 35
Median (90% Confidence Interval)
Unit of Measure: months
High EGFR
17.4
(4.7 to 20.9)
Low EGFR
6.0
(3.0 to 12.4)
Time Frame Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GW572016 (Lapatinib)
Hide Arm/Group Description GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
All-Cause Mortality
GW572016 (Lapatinib)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
GW572016 (Lapatinib)
Affected / at Risk (%)
Total   4/49 (8.16%) 
General disorders   
Fatigue  1  1/49 (2.04%) 
Investigations   
AST Increased  1  1/49 (2.04%) 
Bilirubin Increased  1  2/49 (4.08%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GW572016 (Lapatinib)
Affected / at Risk (%)
Total   46/49 (93.88%) 
Blood and lymphatic system disorders   
Anemia  1  4/49 (8.16%) 
Gastrointestinal disorders   
Constipation  1  3/49 (6.12%) 
Diarrhea w/o Prior Colostomy  1  34/49 (69.39%) 
Flatulence  1  3/49 (6.12%) 
Dyspepsia  1  5/49 (10.20%) 
Nausea  1  3/49 (6.12%) 
Abdominal Pain  1  5/49 (10.20%) 
General disorders   
Fatigue  1  23/49 (46.94%) 
Investigations   
ALT Increased  1  9/49 (18.37%) 
AST Increased  1  7/49 (14.29%) 
Bilirubin Increased  1  9/49 (18.37%) 
Metabolism and nutrition disorders   
Anorexia  1  4/49 (8.16%) 
Hyperglycemia  1  4/49 (8.16%) 
Nervous system disorders   
Neuropathy-Sensory  1  4/49 (8.16%) 
Headache  1  4/49 (8.16%) 
Psychiatric disorders   
Insomnia  1  4/49 (8.16%) 
Respiratory, thoracic and mediastinal disorders   
Nose, Hemorrhage  1  3/49 (6.12%) 
Skin and subcutaneous tissue disorders   
Dry Skin  1  6/49 (12.24%) 
Alopecia  1  3/49 (6.12%) 
Nail Changes  1  6/49 (12.24%) 
Pruritus/Itching  1  6/49 (12.24%) 
Rash/Desquamation  1  9/49 (18.37%) 
Rash: Acne/Acneiform  1  35/49 (71.43%) 
Skin- Other  1  5/49 (10.20%) 
Vascular disorders   
Flushing  1  3/49 (6.12%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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: "Study Statistician"
Organization: "ECOG Statistical Office"
Phone: 617-632-3012
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00103194     History of Changes
Obsolete Identifiers: NCT02154373
Other Study ID Numbers: NCI-2014-01158
NCI-2014-01158 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
E5803 ( Other Identifier: Eastern Cooperative Oncology Group (ECOG) )
CDR0000409729
U10CA180820 ( U.S. NIH Grant/Contract )
U10CA021115 ( U.S. NIH Grant/Contract )
First Submitted: February 7, 2005
First Posted: February 8, 2005
Results First Submitted: November 3, 2011
Results First Posted: April 13, 2012
Last Update Posted: September 30, 2014