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Trial record 24 of 125 for:    lapatinib | Recruiting, Active, not recruiting, Completed Studies | Phase 2

Lapatinib in Treating Patients With Recurrent or Persistent Endometrial Cancer

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: NCT00096447
Recruitment Status : Completed
First Posted : November 10, 2004
Results First Posted : September 18, 2015
Last Update Posted : December 4, 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
Condition Recurrent Endometrial Carcinoma
Intervention Drug: lapatinib ditosylate
Enrollment 31
Recruitment Details The study was activated on 11/1/2004 and closed to accrual on 9/26/2005.
Pre-assignment Details  
Arm/Group Title GW572016
Hide Arm/Group Description 1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
Period Title: Overall Study
Started 31
Completed 30 [1]
Not Completed 1
Reason Not Completed
Never treated             1
[1]
Eligible and treated patients.
Arm/Group Title GW572016
Hide Arm/Group Description 1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
Eligible and treated patients.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
62.0  (11.1)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants
30-39 years 2
40-49 years 4
50-59 years 3
60-69 years 13
70-79 years 8
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
30
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
International Federation of Gynecology and Obstetrics (FIGO) Stage - Recurrent/Persistent  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants
30
Histologic Type  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants
Adenocarcinoma, Unspecified 2
Clear Cell Carcinoma 3
Endometrioid Adenocarcinoma 16
Mixed Epithelial Carcinoma 2
Serous Adenocarcinoma 7
1.Primary Outcome
Title Percentage of Patients With Progression-free Survival > 6 Months
Hide Description Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
Time Frame For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, for up to 5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients.
Arm/Group Title GW572016
Hide Arm/Group Description:
1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
Overall Number of Participants Analyzed 30
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
10
(2.3 to 23.9)
2.Primary Outcome
Title Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0
Hide Description The frequency and severity of all toxicities are tabulated.
Time Frame Every cycle during treatment and 30 days after the last cycle of therapy.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and evaluable patients
Arm/Group Title Grade 0 Grade 1 (CTCAE v 3.0) Grade 2 (CTCAE v 3.0) Grade 3 (CTCAE v 3.0) Grade 4 (CTCAE v 3.0)
Hide Arm/Group Description:
Number of patients who did not experience the specified AE.
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
Overall Number of Participants Analyzed 30 30 30 30 30
Measure Type: Count of Participants
Unit of Measure: Participants
Leukopenia
29
  96.7%
1
   3.3%
0
   0.0%
0
   0.0%
0
   0.0%
Thrombocytopenia
28
  93.3%
2
   6.7%
0
   0.0%
0
   0.0%
0
   0.0%
Anemia
11
  36.7%
8
  26.7%
10
  33.3%
0
   0.0%
1
   3.3%
Cardiovascular
28
  93.3%
1
   3.3%
0
   0.0%
1
   3.3%
0
   0.0%
Constitutional
13
  43.3%
10
  33.3%
7
  23.3%
0
   0.0%
0
   0.0%
Dermatologic
22
  73.3%
6
  20.0%
1
   3.3%
1
   3.3%
0
   0.0%
Gastrointestinal
5
  16.7%
12
  40.0%
7
  23.3%
6
  20.0%
0
   0.0%
Genitourinary/renal
29
  96.7%
0
   0.0%
0
   0.0%
1
   3.3%
0
   0.0%
Hemorrhage
29
  96.7%
0
   0.0%
0
   0.0%
1
   3.3%
0
   0.0%
Lymphatics
29
  96.7%
0
   0.0%
1
   3.3%
0
   0.0%
0
   0.0%
Musculoskeletal
27
  90.0%
2
   6.7%
1
   3.3%
0
   0.0%
0
   0.0%
Metabolic
20
  66.7%
5
  16.7%
2
   6.7%
2
   6.7%
1
   3.3%
Neuropathy
29
  96.7%
1
   3.3%
0
   0.0%
0
   0.0%
0
   0.0%
Other hematologic
27
  90.0%
3
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ocular
26
  86.7%
4
  13.3%
0
   0.0%
0
   0.0%
0
   0.0%
Pain
25
  83.3%
4
  13.3%
1
   3.3%
0
   0.0%
0
   0.0%
Pulmonary
27
  90.0%
1
   3.3%
1
   3.3%
1
   3.3%
0
   0.0%
3.Secondary Outcome
Title Percentage of Patients With Tumor Response
Hide Description Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. 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; Overall Response (OR) = CR + PR.
Time Frame For those patients whose disease can be evaluated by physical examination, response was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, for up to 5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients.
Arm/Group Title GW572016
Hide Arm/Group Description:
1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
Overall Number of Participants Analyzed 30
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
3.3
(0.2 to 14.9)
4.Secondary Outcome
Title Duration of Progression-free Survival
Hide Description Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
Time Frame Every other cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and evaluable patients
Arm/Group Title GW572016
Hide Arm/Group Description:
1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
Overall Number of Participants Analyzed 30
Median (Inter-Quartile Range)
Unit of Measure: months
1.82
(1.41 to 3.48)
5.Secondary Outcome
Title Overall Survival
Hide Description The observed length of life from entry into the study to death or the date of last contact.
Time Frame From study entry to death or last contact, up to 5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients.
Arm/Group Title GW572016
Hide Arm/Group Description:
1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
Overall Number of Participants Analyzed 30
Median (95% Confidence Interval)
Unit of Measure: Months
7.33
(3.94 to 15.77)
6.Secondary Outcome
Title Prognostic Factors (Performance Status)
Hide Description

Performance status 0 = Fully active, able to carry on all pre-disease performance without restriction.

Performance status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work.

Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and evaluable
Arm/Group Title GW572016
Hide Arm/Group Description:
1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
Performance status 0
19
  63.3%
Performance status 1
11
  36.7%
7.Secondary Outcome
Title Prognostic Factor (Histologic Grade)
Hide Description G1 - Highly differentiated adenomatous carcinoma. G2 - Differentiated adenomatous carcinoma with partly solid areas. G3 - Predominantly solid or entirely undifferentiated carcinoma. Not graded - tumor grade not reported.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and evaluable
Arm/Group Title GW572016
Hide Arm/Group Description:
1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1
3
  10.0%
Grade 2
6
  20.0%
Grade 3
14
  46.7%
Not graded
7
  23.3%
Time Frame All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GW572016
Hide Arm/Group Description 1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
All-Cause Mortality
GW572016
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
GW572016
Affected / at Risk (%)
Total   10/30 (33.33%) 
Blood and lymphatic system disorders   
Hemoglobin * 1  2/30 (6.67%) 
Gastrointestinal disorders   
Fistula, Gi - Rectum * 1  1/30 (3.33%) 
Obstruction, Gi - Jejunum * 1  1/30 (3.33%) 
Nausea * 1  1/30 (3.33%) 
Diarrhea * 1  1/30 (3.33%) 
General disorders   
Death No Ctcae Term - Disease Progression Nos * 1  1/30 (3.33%) 
Infections and infestations   
Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia) * 1  1/30 (3.33%) 
Inf Unknown Anc: Skin (Cellulitis) * 1  1/30 (3.33%) 
Renal and urinary disorders   
Obstruction, Gu - Ureter * 1  1/30 (3.33%) 
Fistula, Gu - Vagina * 1  1/30 (3.33%) 
Renal Failure * 1  1/30 (3.33%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea * 1  1/30 (3.33%) 
*
Indicates events were collected by non-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 0%
GW572016
Affected / at Risk (%)
Total   30/30 (100.00%) 
Blood and lymphatic system disorders   
Platelets * 1  2/30 (6.67%) 
Leukocytes * 1  2/30 (6.67%) 
Hemoglobin * 1  21/30 (70.00%) 
Edema: Viscera * 1  1/30 (3.33%) 
Edema: Limb * 1  1/30 (3.33%) 
Cardiac disorders   
S/N Arrhythmia: Atrial Fibrillation * 1  1/30 (3.33%) 
S/N Arrhythmia: Atrial Tachycardia * 1  1/30 (3.33%) 
Hypertension * 1  2/30 (6.67%) 
Valvular Heart Disease * 1  1/30 (3.33%) 
Left Venticular Diastolic Dysfunction * 1  1/30 (3.33%) 
Lt Ventricular Systolic Dysfunction * 1  2/30 (6.67%) 
Hypotension * 1  2/30 (6.67%) 
Endocrine disorders   
Hot Flashes * 1  2/30 (6.67%) 
Diabetes * 1  1/30 (3.33%) 
Eye disorders   
Glaucoma * 1  1/30 (3.33%) 
Dry Eye * 1  1/30 (3.33%) 
Blurred Vision * 1  3/30 (10.00%) 
Gastrointestinal disorders   
Flatulence * 1  2/30 (6.67%) 
Heartburn * 1  4/30 (13.33%) 
Dysphagia * 1  1/30 (3.33%) 
Distention * 1  1/30 (3.33%) 
Taste Alteration * 1  1/30 (3.33%) 
Mucositis (Functional/Sympt) - Oral Cavity * 1  1/30 (3.33%) 
Mucositis (Clinical Exam) - Oral Cavity * 1  1/30 (3.33%) 
Vomiting * 1  8/30 (26.67%) 
Anorexia * 1  15/30 (50.00%) 
Dehydration * 1  3/30 (10.00%) 
Constipation * 1  6/30 (20.00%) 
Nausea * 1  15/30 (50.00%) 
Diarrhea * 1  18/30 (60.00%) 
General disorders   
Sweating * 1  3/30 (10.00%) 
Weight Gain * 1  1/30 (3.33%) 
Fever * 1  2/30 (6.67%) 
Weight Loss * 1  3/30 (10.00%) 
Rigors/Chills * 1  1/30 (3.33%) 
Fatigue * 1  20/30 (66.67%) 
Insomnia * 1  6/30 (20.00%) 
Pain: Pelvis * 1  1/30 (3.33%) 
Pain: Vagina * 1  1/30 (3.33%) 
Pain: Chest /Thorax Nos * 1  1/30 (3.33%) 
Pain: Chest Wall * 1  1/30 (3.33%) 
Pain: Head/Headache * 1  2/30 (6.67%) 
Pain: Extremity-Limb * 1  4/30 (13.33%) 
Pain: Back * 1  3/30 (10.00%) 
Pain: Joint * 1  5/30 (16.67%) 
Pain: Stomach * 1  1/30 (3.33%) 
Pain: Oral Cavity * 1  1/30 (3.33%) 
Pain: Dental/Teeth/Peridontal * 1  1/30 (3.33%) 
Pain: Abdominal Pain Nos * 1  5/30 (16.67%) 
Pain: Lip * 1  2/30 (6.67%) 
Pain: Middle Ear * 1  1/30 (3.33%) 
Pain: Tumor * 1  3/30 (10.00%) 
Pain: Muscle * 1  2/30 (6.67%) 
Immune system disorders   
Rhinitis * 1  1/30 (3.33%) 
Infections and infestations   
Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos * 1  1/30 (3.33%) 
Inf Unknown Anc: Lung (Pneumonia) * 1  1/30 (3.33%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos * 1  1/30 (3.33%) 
Inf Unknown Anc: Blood * 1  1/30 (3.33%) 
Infection - Other * 1  1/30 (3.33%) 
Inf Unknown Anc: Bladder (Urinary) * 1  1/30 (3.33%) 
Inf Unknown Anc: Wound * 1  1/30 (3.33%) 
Inf Unknown Anc: Ungual (Nails) * 1  1/30 (3.33%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Bladder * 1  3/30 (10.00%) 
Inf W/Gr 3 Or 4 Anc: Urinary Tract Nos * 1  1/30 (3.33%) 
Metabolism and nutrition disorders   
Ast * 1  2/30 (6.67%) 
Proteinuria * 1  2/30 (6.67%) 
Creatinine * 1  3/30 (10.00%) 
Hypoalbuminemia * 1  2/30 (6.67%) 
Alt * 1  2/30 (6.67%) 
Alkaline Phosphatase * 1  6/30 (20.00%) 
Bilirubin * 1  1/30 (3.33%) 
Hyponatremia * 1  3/30 (10.00%) 
Hypocalcemia * 1  3/30 (10.00%) 
Hyperglycemia * 1  7/30 (23.33%) 
Hypokalemia * 1  3/30 (10.00%) 
Hypercalcemia * 1  1/30 (3.33%) 
Hypomagnesemia * 1  4/30 (13.33%) 
Musculoskeletal and connective tissue disorders   
Arthritis * 1  1/30 (3.33%) 
Muscle Weakness - Whole Body/Generalized * 1  3/30 (10.00%) 
Muscle Weakness - Extremity-Lower * 1  1/30 (3.33%) 
Nervous system disorders   
Mood Alteration - Depression * 1  3/30 (10.00%) 
Tremor * 1  1/30 (3.33%) 
Somnolence * 1  1/30 (3.33%) 
Ataxia * 1  1/30 (3.33%) 
Memory Impairment * 1  1/30 (3.33%) 
Dizziness * 1  1/30 (3.33%) 
Neuropathy-Sensory * 1  2/30 (6.67%) 
Neuropathy-Motor * 1  1/30 (3.33%) 
Renal and urinary disorders   
Urinary Retention * 1  1/30 (3.33%) 
Fistula, Gu - Vagina * 1  1/30 (3.33%) 
Fistula, Gu - Genital Tract-Female * 1  1/30 (3.33%) 
Renal Failure * 1  1/30 (3.33%) 
Urinary Frequency * 1  2/30 (6.67%) 
Reproductive system and breast disorders   
Vaginal Discharge * 1  1/30 (3.33%) 
Respiratory, thoracic and mediastinal disorders   
Nasal/Paranasal Reactions * 1  1/30 (3.33%) 
Cough * 1  1/30 (3.33%) 
Dyspnea * 1  9/30 (30.00%) 
Skin and subcutaneous tissue disorders   
Nail Changes * 1  1/30 (3.33%) 
Hair Loss/Alopecia (Scalp Or Body) * 1  1/30 (3.33%) 
Rash * 1  8/30 (26.67%) 
Flushing * 1  1/30 (3.33%) 
Dermatology/Skin - Other * 1  1/30 (3.33%) 
Vascular disorders   
Inr * 1  1/30 (3.33%) 
Ptt * 1  1/30 (3.33%) 
Hemorrhage, Gu - Urinary Nos * 1  1/30 (3.33%) 
Hemorrhage, Gu - Vagina * 1  3/30 (10.00%) 
Hemorrhage, Gi - Upper Gi Nos * 1  1/30 (3.33%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
The clinical trial was a two-stage design, accruing approximately 25 patients in each stage. Results from a planned interim futility analysis resulted in the early closure of the study. This study stopped early for lack of treatment efficacy.
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: Angela M. Kuras, Associate Director of Data Management
Organization: NRG Oncology Statistics and Data Management Center - Buffalo
Phone: 716-845-7733
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00096447     History of Changes
Other Study ID Numbers: NCI-2012-02631
GOG-0229D
U10CA027469 ( U.S. NIH Grant/Contract )
CDR0000393398 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: November 9, 2004
First Posted: November 10, 2004
Results First Submitted: June 3, 2015
Results First Posted: September 18, 2015
Last Update Posted: December 4, 2017