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Lapatinib in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Peritoneal 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: NCT00113373
Recruitment Status : Completed
First Posted : June 8, 2005
Results First Posted : June 11, 2015
Last Update Posted : June 6, 2018
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 Primary Peritoneal Cavity Cancer
Recurrent Ovarian Epithelial Cancer
Interventions Drug: lapatinib ditosylate
Other: laboratory biomarker analysis
Enrollment 28
Recruitment Details The study was activated on 5/2/2005 and closed to accrual on 5/1/2006.
Pre-assignment Details  
Arm/Group Title Lapatinib
Hide Arm/Group Description 1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
Period Title: Overall Study
Started 28
Completed 25 [1]
Not Completed 3
Reason Not Completed
Ineligible: wrong primary             1
Ineligible: second primary             1
Never Treated             1
[1]
Eligible and treated patients.
Arm/Group Title Lapatinib
Hide Arm/Group Description 1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
Eligible and treated patients.
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants
63.4  (9.3)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 25 participants
40-49 years 3
50-59 years 4
60-69 years 12
70-79 years 4
80-89 years 2
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
25
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants
25
International Federation of Gynecology and Obstetrics (FIGO) Stage Recurrent/Persistent  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 25 participants
25
Histologic Type  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 25 participants
Endometrioid Adenocarcinoma 3
Undifferentiated Carcinoma 2
Serous Adenocarcinoma 20
1.Primary Outcome
Title Progression-free Survival (PFS) > 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 measurable disease every other cycle for the first 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and Treated Patients
Arm/Group Title Lapatinib
Hide Arm/Group Description:
1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
Overall Number of Participants Analyzed 25
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
8.0
(1.4 to 23.1)
2.Primary Outcome
Title Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria for Adverse Events (CTCAE) v3.0
Hide Description [Not Specified]
Time Frame Assessed every cycle while on treatment, 30 days after the last cycle of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and evaluable
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 25 25 25 25 25
Measure Type: Count of Participants
Unit of Measure: Participants
Leukopenia
23
  92.0%
2
   8.0%
0
   0.0%
0
   0.0%
0
   0.0%
Thrombocytopenia
24
  96.0%
1
   4.0%
0
   0.0%
0
   0.0%
0
   0.0%
Anemia
12
  48.0%
10
  40.0%
3
  12.0%
0
   0.0%
0
   0.0%
Other hematologic
24
  96.0%
1
   4.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hearing
21
  84.0%
0
   0.0%
4
  16.0%
0
   0.0%
0
   0.0%
Constitutional
12
  48.0%
9
  36.0%
1
   4.0%
2
   8.0%
1
   4.0%
Dermatologic
15
  60.0%
6
  24.0%
4
  16.0%
0
   0.0%
0
   0.0%
Gastrointestinal
5
  20.0%
11
  44.0%
5
  20.0%
4
  16.0%
0
   0.0%
Hemorrhage
23
  92.0%
2
   8.0%
0
   0.0%
0
   0.0%
0
   0.0%
Infection
24
  96.0%
0
   0.0%
1
   4.0%
0
   0.0%
0
   0.0%
Lymphatics
24
  96.0%
1
   4.0%
0
   0.0%
0
   0.0%
0
   0.0%
Musculoskeletal
22
  88.0%
1
   4.0%
1
   4.0%
1
   4.0%
0
   0.0%
Metabolic
13
  52.0%
8
  32.0%
2
   8.0%
2
   8.0%
0
   0.0%
Neuropathy
21
  84.0%
2
   8.0%
1
   4.0%
1
   4.0%
0
   0.0%
Ocular
24
  96.0%
1
   4.0%
0
   0.0%
0
   0.0%
0
   0.0%
Pain
17
  68.0%
7
  28.0%
0
   0.0%
1
   4.0%
0
   0.0%
Pulmonary
23
  92.0%
2
   8.0%
0
   0.0%
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Tumor Response
Hide Description RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Time Frame Baseline, every other cycle for 6 months and then every 6 months for up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and Treated Patients
Arm/Group Title Lapatinib
Hide Arm/Group Description:
1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
Overall Number of Participants Analyzed 25
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
0
(0.0 to 8.8)
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 for 6 months and then every 6 months for up to 5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and evaluable patients
Arm/Group Title Lapatinib
Hide Arm/Group Description:
1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
Overall Number of Participants Analyzed 25
Median (95% Confidence Interval)
Unit of Measure: months
1.77
(1.28 to 1.87)
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 entry into the study to death or the date of last contact, assessed up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and Treated Patients
Arm/Group Title Lapatinib
Hide Arm/Group Description:
1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
Overall Number of Participants Analyzed 25
Median (95% Confidence Interval)
Unit of Measure: months
10.5
(3.4 to 17.0)
6.Secondary Outcome
Title Prognostic Variable: Platinum Sensitivity
Hide Description Patients who had disease progression within 6 months of ending their last regimen of platinum therapy were considered platinum resistant. Patients who had disease progression between 6 and 12 months of ending their last platinum regimen were considered platinum sensitive. Patients who had disease progression beyond12 months of ending their last platinum regimen were also considered platinum sensitive.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and evaluable patients
Arm/Group Title Lapatinib
Hide Arm/Group Description:
1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
Overall Number of Participants Analyzed 25
Measure Type: Count of Participants
Unit of Measure: Participants
Platinum Sensitive
9
  36.0%
Platinum Resistant
16
  64.0%
7.Secondary Outcome
Title Prognostic Variables: 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 Performance Status 2 = Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients
Arm/Group Title Lapatinib
Hide Arm/Group Description:
1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
Overall Number of Participants Analyzed 25
Measure Type: Count of Participants
Unit of Measure: Participants
Performance Status 0
18
  72.0%
Performance Status 1
6
  24.0%
Performance Status 2
1
   4.0%
8.Secondary Outcome
Title Prognostic Variable: Cellular Histology
Hide Description Number of patients with Clear Cell Carcinoma or Mucinous Carcinoma
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and evaluable patients
Arm/Group Title Lapatinib
Hide Arm/Group Description:
1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
Overall Number of Participants Analyzed 25
Measure Type: Count of Participants
Unit of Measure: Participants
Clear Cell Carcinoma
0
   0.0%
Mucinous Carcinoma
0
   0.0%
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 Lapatinib
Hide Arm/Group Description 1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
All-Cause Mortality
Lapatinib
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lapatinib
Affected / at Risk (%)
Total   10/25 (40.00%) 
Gastrointestinal disorders   
Ileus * 1  2/25 (8.00%) 
Obstruction, Gi - Small Bowel Nos * 1  1/25 (4.00%) 
Nausea * 1  1/25 (4.00%) 
General disorders   
Death No Ctcae Term - Disease Progression Nos * 1  3/25 (12.00%) 
Death No Ctcae Term - Death Nos * 1  1/25 (4.00%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea * 1  1/25 (4.00%) 
Skin and subcutaneous tissue disorders   
Acne * 1  1/25 (4.00%) 
*
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%
Lapatinib
Affected / at Risk (%)
Total   25/25 (100.00%) 
Blood and lymphatic system disorders   
Platelets * 1  1/25 (4.00%) 
Leukocytes * 1  2/25 (8.00%) 
Lymphopenia * 1  2/25 (8.00%) 
Hemoglobin * 1  15/25 (60.00%) 
Edema: Limb * 1  2/25 (8.00%) 
Cardiac disorders   
Hypertension * 1  2/25 (8.00%) 
Ear and labyrinth disorders   
Tinnitus * 1  4/25 (16.00%) 
Endocrine disorders   
Hot Flashes * 1  2/25 (8.00%) 
Hypothyroidism * 1  1/25 (4.00%) 
Eye disorders   
Flashing Lights/Floaters * 1  1/25 (4.00%) 
Gastrointestinal disorders   
Esophagitis * 1  1/25 (4.00%) 
Heartburn * 1  1/25 (4.00%) 
Ascites * 1  1/25 (4.00%) 
Dysphagia * 1  1/25 (4.00%) 
Distention * 1  4/25 (16.00%) 
Taste Alteration * 1  1/25 (4.00%) 
Dry Mouth * 1  1/25 (4.00%) 
Mucositis (Functional/Sympt) - Oral Cavity * 1  1/25 (4.00%) 
Colitis * 1  1/25 (4.00%) 
Mucositis (Clinical Exam) - Oral Cavity * 1  2/25 (8.00%) 
Vomiting * 1  7/25 (28.00%) 
Anorexia * 1  5/25 (20.00%) 
Dehydration * 1  2/25 (8.00%) 
Constipation * 1  8/25 (32.00%) 
Nausea * 1  16/25 (64.00%) 
Diarrhea * 1  18/25 (72.00%) 
General disorders   
Sweating * 1  1/25 (4.00%) 
Weight Loss * 1  2/25 (8.00%) 
Fatigue * 1  13/25 (52.00%) 
Death No Ctcae Term - Death Nos * 1  1/25 (4.00%) 
Pain: Pelvis * 1  1/25 (4.00%) 
Pain: Vagina * 1  1/25 (4.00%) 
Pain: Head/Headache * 1  4/25 (16.00%) 
Pain: Extremity-Limb * 1  1/25 (4.00%) 
Pain: Back * 1  1/25 (4.00%) 
Pain: Joint * 1  1/25 (4.00%) 
Pain: Bladder * 1  1/25 (4.00%) 
Pain: Stomach * 1  2/25 (8.00%) 
Pain: Oral Cavity * 1  1/25 (4.00%) 
Pain: Abdominal Pain Nos * 1  10/25 (40.00%) 
Pain: Muscle * 1  2/25 (8.00%) 
Infections and infestations   
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos * 1  1/25 (4.00%) 
Colitis, Infectious (Eg.C. Difficile) * 1  1/25 (4.00%) 
Inf Unknown Anc: Urinary Tract Nos * 1  1/25 (4.00%) 
Inf Unknown Anc: Bladder (Urinary) * 1  1/25 (4.00%) 
Metabolism and nutrition disorders   
Ast * 1  3/25 (12.00%) 
Cholesterol,serum High * 1  1/25 (4.00%) 
Creatinine * 1  5/25 (20.00%) 
Hypoalbuminemia * 1  4/25 (16.00%) 
Alt * 1  3/25 (12.00%) 
Alkaline Phosphatase * 1  3/25 (12.00%) 
Bilirubin * 1  1/25 (4.00%) 
Hyponatremia * 1  6/25 (24.00%) 
Hyperuricemia * 1  1/25 (4.00%) 
Bicarbonate, Serum-Low * 1  1/25 (4.00%) 
Hypocalcemia * 1  3/25 (12.00%) 
Hyperkalemia * 1  1/25 (4.00%) 
Hyperglycemia * 1  9/25 (36.00%) 
Hypokalemia * 1  4/25 (16.00%) 
Hypoglycemia * 1  1/25 (4.00%) 
Hypercalcemia * 1  1/25 (4.00%) 
Hypomagnesemia * 1  4/25 (16.00%) 
Musculoskeletal and connective tissue disorders   
Soft Tissue Necrosis - Abdomen * 1  1/25 (4.00%) 
Osteoporosis * 1  1/25 (4.00%) 
Joint-Function * 1  1/25 (4.00%) 
Arthritis * 1  1/25 (4.00%) 
Muscle Weakness - Whole Body/Generalized * 1  1/25 (4.00%) 
Nervous system disorders   
Mood Alteration - Depression * 1  7/25 (28.00%) 
Mood Alteration - Anxiety * 1  1/25 (4.00%) 
Confusion * 1  1/25 (4.00%) 
Memory Impairment * 1  1/25 (4.00%) 
Dizziness * 1  1/25 (4.00%) 
Neuropathy-Sensory * 1  5/25 (20.00%) 
Renal and urinary disorders   
Bladder Spasm * 1  1/25 (4.00%) 
Urinary Frequency * 1  2/25 (8.00%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  3/25 (12.00%) 
Dyspnea * 1  7/25 (28.00%) 
Skin and subcutaneous tissue disorders   
Nail Changes * 1  1/25 (4.00%) 
Hair Loss/Alopecia (Scalp Or Body) * 1  4/25 (16.00%) 
Acne * 1  5/25 (20.00%) 
Rash * 1  5/25 (20.00%) 
Dry Skin * 1  4/25 (16.00%) 
Pruritus * 1  2/25 (8.00%) 
Hand-Foot * 1  1/25 (4.00%) 
Vascular disorders   
Hemorrhage, Gu - Vagina * 1  2/25 (8.00%) 
Hemorrhage, Gi - Rectum * 1  1/25 (4.00%) 
Hemorrhage/Pulmonary - Nose * 1  3/25 (12.00%) 
Hemorrhage, Gu - Bladder * 1  1/25 (4.00%) 
*
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. Early termination of the study would result if warranted from an interim futility analysis. 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 Statistics and Data Management Center - Buffalo
Phone: 716-845-7733
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00113373     History of Changes
Other Study ID Numbers: NCI-2012-02654
NCI-2012-02654 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000429548
GOG-0170G ( Other Identifier: Gynecologic Oncology Group )
GOG-0170G ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: June 7, 2005
First Posted: June 8, 2005
Results First Submitted: May 28, 2015
Results First Posted: June 11, 2015
Last Update Posted: June 6, 2018